Back to resultsA Study to Evaluate the Efficacy and Safety of Eptinezumab for the Prevention of Migraine in Participants That Are Not Helped by Previous Preventive Treatments (DELIVER)
Primary Purpose
Migraine
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Eptinezumab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Migraine
Eligibility Criteria
Inclusion Criteria:
- The participant has a diagnosis of migraine, with a history of chronic or episodic migraines of at least 12 months prior to the Screening Visit
- The participant has a migraine onset of ≤50 years of age.
- The participant has ≥4 migraine days per month for each month within the past 3 months prior to the Screening Visit.
- The participant has demonstrated compliance with the Headache eDiary by entry of data for at least 24 of the 28 days following the Screening Visit.
- The participant fulfils the following criteria for chronic migraine (CM) or episodic migraine (EM) in prospectively collected information in the eDiary during the screening period:
- For participants with CM: Migraine occurring on ≥8 days and headache occurring on >14 days
- For participants with EM: Migraine occurring on ≥4 days and headache occurring on ≤14 days
- The participant has documented evidence of treatment failure (must be supported by medical record or by physician's confirmation specific to each treatment) in the past 10 years of 2-4 different migraine preventive medications.
- The participant has a history of either previous or active use of triptans for migraine.
Exclusion Criteria:
- The participant has experienced failure on a previous treatment targeting the calcitonin gene-related peptide (CGRP) pathway.
- The participant has a treatment failure on valproate/divalproex or botulinum toxin A/B and the treatment is not the latest preventive medication prior to study inclusion. The medication is regarded as the latest if the medication start date is after the start date of the other preventive medications and the medication stop date is after the stop date of the other preventive medications.
- The participant has confounding and clinically significant pain syndromes, (for example, fibromyalgia, chronic low back pain, complex regional pain syndrome).
- The participant has a diagnosis of acute or active temporomandibular disorder.
- The participant has a history or diagnosis of chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes such as hemiplegic migraine (sporadic and familial), ophthalmoplegic migraine, and migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration).
- The participant has a psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit. Participants with a lifetime history of psychosis and/or mania in the last 5 years prior to the Screening Visit are excluded.
- The participant has a history of clinically significant cardiovascular disease or vascular ischaemia or thromboembolic events (for example, cerebrovascular accident, deep vein thrombosis, or pulmonary embolism).
Other in- and exclusion criteria may apply
Sites / Locations
- Diablo Clinical Research
- Sarkis Clinical Trials - Gainesville
- Accel Research Sites - Maitland
- Michigan Headache and Neurological Institute
- Clinical Research Institute Inc. - Minneapolis
- Albuqerque Clinical Trials
- Dent Neurologic Institute - Amherst
- Integrative Clinical Trials
- CTI Clinical Research Center
- Hometown Urgent Care & Occupational Health/Hometown Research - Huber Heights
- Lynn Health Science Institute - Oklahoma City
- Clinical Neuroscience Solutions - Memphis
- Northwest Clinical Research Center (NWCRC)
- Northwest Neurological
- Universitair Ziekenhuis Brussel
- Jessa Ziekenhuis - Campus Virga Jesse
- Universitair Ziekenhuis Gent
- Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan
- Multiprofile Hospital for Active Treatment in Neurology and Psychiatry Sveti Naum
- First Multiprofile Hospital for Active Treatment - Sofia
- Multiprofile Hospital for Active Treatment Heart and Brain EAD
- Medical Center - Teodora EOOD
- Acibadem City Clinic Tokuda Hospital
- Medical Center Medica Plus
- MUDr. Helena Hojdíkova s.r.o. Neurologicka Ambulance
- Vestra Clinics
- CCR Brno
- Fakultni nemocnice Ostrava
- Fakultní Thomayerova nemocnice
- Neurologicka Ambulance - Forbeli
- Neuropsychiatrie S.R.O.
- Institut Neuropsychiatrické Péce
- CCR Prague
- CCR Ostrava
- Fakultní Nemocnice u sv. Anny v Brne
- Nemocnice Jihlava
- Neurosanatio s.r.o
- Neurologie, MP-neuro s.r.o., poliklinika Modry pavilon
- NeuroMed Zlín s.r.o.
- Rigshospitalet Glostrup
- Odense Universitetshospital
- Sydvestjysk Sygehus - Esbjerg
- Tampereen Yliopistollinen Sairaala
- Terveystalo Ruoholahti
- Terveystalo Turku Pulssi
- Itä-Suomen Yliopisto - Kuopion Kampus
- Terveystalo Tampere
- Hôpital Cimiez
- Hôpital Charles-Nicolle
- Hôpital Roger Salengro
- Centre Hosptitalier Universitaire d'Angers
- Assistance Publique Hôpitaux de Marseille
- Hôpital Pierre Wertheimer
- Helsicore - Israeli-Georgian Medical Research Clinic
- LLC Todua Clinic
- Pineo Medical Ecosystem
- Archangel Saint Michael Multiprofile Clinical Hospital
- Aversi Clinic - Central Branch
- Mediclub Georgia Medical
- Jerarsi Clinic
- Malkhaz Katsiashvili Multiprofile Emergency Center
- Simon Khechinashvili University Hospital
- Consilium Medulla Multiprofile Clinic
- MVZ Dr. Roth & Kollegen GbR
- Neuroplus
- NeuroConcept AG
- Praxis Dr. Steinwachs
- CTC North
- Migräne- und Kopfschmerzklinik Königstein
- Synexus - Prüfzentrum Frankfurt/Main
- Studienzentrum Nord West
- Neurozentrum Bielefeld
- Neurologische Praxis Dr. Stude
- Praxis Astrid Gendolla
- Universitätsklinikum Essen
- Synexus - Leipzig
- Synexus Clinical Research - Berlin
- Neuropraxis München Süd
- Valeomed Diagnosztikai Kozpont
- Pest Megyei Flor Ferenc Korhaz
- UNO Medical Trials Kft.
- Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - San Raffaele Pisana
- Universita Campus Bio-Medico di Roma
- Azienda Ospedaliera - Universitaria Sant' Andrea
- IRCCS Istituto Delle Scienze Neurologiche di Bologna
- Azienda Ospedaliero - Universitaria Careggi
- Fondazione Mondino - Istituto Neurologico Nazionale a Carattere Scientifico IRCCS
- Centrum Medyczne Oporow
- Centrum Medyczne Pratia - Bydgoszcz
- Prywatny Gabinet Lekarski Urszula Chyrchel-Paszkiewicz
- Indywidualna Praktyka Lekarska dr hab. n. med. Anna Szczepanska-Szerej
- Pratia MCM Krakow
- Specjalistyczne Gabinety Sp. z o.o.
- Instytut Zdrowia dr Boczarska-Jedynak
- Concept Medica Trials Prywatny Gabinet Lekarski Urszula Chyrchel-Paszkiewicz
- SOMED CR - Warsaw
- MTZ Clinical Research Powered by Pratia
- Synexus - Gdynia
- Neuro-Care Katowice
- Synexus - Czestochowa
- Synexus - Katowice
- Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska
- Centrum Medyczne Solumed
- Synexus - Poznan
- Centrum Medyczne Pratia - Czestochowa
- SOMED CR - Lodz
- University Headache Clinic
- Neurologicka ambulancia MUDr. Dupejova s.r.o.
- In Medic
- MEDBAJ s.r.o.
- Medicínske Centrum Konzílium - Dubnica nad Vahom
- Hospital Universitario de Basurto
- Hospital Universitario Puerta de Hierro - Majadahonda
- Hospital Universitario Quironsalud Madrid
- Clinica Universidad de Navarra - Pamplona
- Hospital Alvaro Cunqueiro - Clinico Universitario Vigo
- Hospital Universitari Vall d'Hebron
- Hospital Universitario La Paz
- Hospital Universitario Virgen del Rocío
- Hospital Clínico Universitario de Valladolid
- Hospital Clínico Universitario de Valencia
- Hospital Clinico Universitario Lozano Blesa
- Migränkliniken Europa AB
- Stortorgets neurologmottagning
- Centralsjukhuset Kristianstad
- Universitetssjukhuset i Linköping
- Synexus - Scotland Clinical Research Centre
- Synexus - The Lancashire Clinic
- Synexus Midlands Clinical Research Centre
- Synexus - The Hexham Clinic
- Synexus - Merseyside Clinical Research Centre
- Panthera Biopartners - North London
- Synexus - Manchester Clinical Research Centre
- Panthera Biopartners - Manchester
- Panthera Biopartners - Preston
- Synexus - Thames Valley Clinical Research Centre
- Northern Care Alliance NHS Foundation Trust
- Synexus - Wales
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Placebo
Eptinezumab 100 mg
Eptinezumab 300 mg
Arm Description
Participants will receive placebo matching to eptinezumab by IV infusion, every 12 weeks starting from Baseline (Day 0) through Week 24.
Participants will receive eptinezumab 100 mg by IV infusion, every 12 weeks starting from Baseline (Day 0) through Week 24.
Participants will receive eptinezumab 300 mg by IV infusion, every 12 weeks starting from Baseline (Day 0) through Week 24.
Outcomes
Primary Outcome Measures
Change From Baseline in the Number of Monthly Migraine Days (MMDs) Averaged Over Weeks 1 to 12
A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.
Secondary Outcome Measures
Percentage of Participants With ≥50% Reduction From Baseline in MMDs Averaged Over Weeks 1 to 12
A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.
Change From Baseline in the Number of MMDs Averaged Over Weeks 13 to 24
A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.
Percentage of Participants With ≥75% Reduction From Baseline in MMDs Averaged Over Weeks 1 to 12
A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.
Change From Baseline in the Headache Impact Test (HIT-6) Score at Week 12
The HIT-6 (version 1.0) is a Likert-type, self-reporting questionnaire designed to assess the impact of an occurring headache and its effect on the ability to function normally in daily life. The HIT-6 contains 6 questions, each item was rated from never to always with the following response scores: never = 6, rarely = 8, sometimes = 10, very often = 11, and always = 13. The total score for the HIT-6 was the sum of each response score ranging from 36 to 78. The life impact derived from the total score was described as followed: severe (≥60), substantial (56-59), some (50-55), little to none (≤49).
Percentage of Participants With ≥50% Reduction From Baseline in MMDs Averaged Over Weeks 13 to 24
A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.
Percentage of Participants With ≥75% Reduction From Baseline in MMDs Averaged Over Weeks 13 to 24
A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.
Percentage of Participants With 100% Reduction From Baseline in MMDs Averaged Over Weeks 1 to 12
A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.
Percentage of Participants With ≥50% Reduction From Baseline in Monthly Headache Days (MHDs) Averaged Over Weeks 1 to 12
A headache day was defined as a day with a headache that lasted ≥30 minutes or met the definition of a migraine day (as defined in criterion A, B, C, or D above in outcome measure 1).
Percentage of Participants With ≥75% Reduction From Baseline in Monthly Headache Days (MHDs) Averaged Over Weeks 1 to 12
A headache day was defined as a day with a headache that lasted ≥30 minutes or met the definition of a migraine day (as defined in criterion A, B, C, or D above in outcome measure 1).
Percentage of Participants With 100% Reduction From Baseline in Monthly Headache Days (MHDs) Averaged Over Weeks 1 to 12
A headache day was defined as a day with a headache that lasted ≥30 minutes or met the definition of a migraine day (as defined in criterion A, B, C, or D above in outcome measure 1).
Change From Baseline in the Number of MHDs Averaged Over Weeks 1 to 12
A headache day was defined as a day with a headache that lasted ≥30 minutes or met the definition of a migraine day (as defined in criterion A, B, C, or D above in outcome measure 1).
Change From Baseline in the Percentage of Migraine Attacks With Severe Pain Intensity Averaged Over Weeks 1 to 12
A migraine attack was defined as a headache that occurred on a single day or lasted >1 day and that met the criteria for a migraine day (as defined in criterion A, B, C, or D above in outcome measure 1).
Change From Baseline in the Percentage of Headache Episodes With Severe Pain Intensity Averaged Over Weeks 1 to 12
A headache episode was defined as a headache lasted ≥30 minutes or that met the criteria for a migraine (as defined in criterion A, B, C, or D above in outcome measure 1).
Change From Baseline in the Number of Monthly Days With Use of Acute Migraine Medication Averaged Over Weeks 1 to 12
In the evening eDiary, participants were asked each day to fill out whether they used any of the following medications during that day: Ergotamine, triptan, analgesic, opioid, or combination analgesic. A day where the participant answered that they took any of those in the evening eDiary was considered a day with use of acute migraine medication.
Change From Baseline in the Number of Monthly Days With Use of Acute Migraine Medication Averaged Over Weeks 13 to 24
In the evening eDiary, participants were asked each day to fill out whether they used any of the following medications during that day: Ergotamine, triptan, analgesic, opioid, or combination analgesic. A day where the participant answered that they took any of those in the evening eDiary was considered a day with use of acute migraine medication.
Change From Baseline in the Number of MMDs With Use of Acute Medication Averaged Over Weeks 1 to 12
Number of MMDs with acute medication usage was derived using the answer to "Did you take any medications to treat this headache?" in the headache diary. The question was asked when a participant was ending a headache. Thus, a migraine day with acute medication usage was defined as a migraine day with the extra condition that this question was answered as "Yes".
Change From Baseline in the Number of MMDs With Use of Acute Medication Averaged Over Weeks 13 to 24
Number of MMDs with acute medication usage was derived using the answer to "Did you take any medications to treat this headache?" in the headache diary. The question was asked when a participant was ending a headache. Thus, a migraine day with acute medication usage was defined as a migraine day with the extra condition that this question was answered as "Yes".
Patient Global Impression of Change (PGIC) Score at Week 12
The PGIC is a single, participant-reported item reflecting the participant's impression of change in his/her disease status since the start of the study (that is, in relation to activity limitations, symptoms, emotions, and overall quality of life). Participants rated their impression of change in disease status on a 7-point scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse) where a higher score indicated worsening. Score ranges from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status.
PGIC Score at Week 24
The PGIC is a single, participant-reported item reflecting the participant's impression of change in his/her disease status since the start of the study (that is, in relation to activity limitations, symptoms, emotions, and overall quality of life). Participants rated their impression of change in disease status on a 7-point scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse) where a higher score indicated worsening. Score ranges from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status.
Change From Baseline in the Number of MMDs in Participants With Medication Overuse Headache (MOH) Averaged Over Weeks 1 to 12
Percentage of Participants With Migraine on the Day After First Dosing
Most Bothersome Symptom (MBS) Score at Week 12
Participants were asked about their most bothersome symptom associated with their migraines during the Baseline Visit. Participants were asked to rate the improvement in this symptom from baseline on a 7-point scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse) where a high score indicated worsening. Score ranges from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status. The MBS areas included: nausea, vomiting, sensitivity to light, sensitivity to sound, mental cloudiness, fatigue, pain with activity, mood changes, and other symptoms.
Change From Baseline in the HIT-6 Score at Week 24
The HIT-6 (version 1.0) is a Likert-type, self-reporting questionnaire designed to assess the impact of an occurring headache and its effect on the ability to function normally in daily life. The HIT-6 contains 6 questions, each item was rated from never to always with the following response scores: never = 6, rarely = 8, sometimes = 10, very often = 11, and always = 13. The total score for the HIT-6 was the sum of each response score ranging from 36 to 78. The life impact derived from the total score was described as followed: severe (≥60), substantial (56-59), some (50-55), little to none (≤49).
Change From Baseline in the Migraine-Specific Quality of Life (MSQ) Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Week 12
The MSQ is a participant-reported outcome designed to assess the quality of life in participants with migraine. It consists of 14 items covering 3 domains: role function restrictive (7 items); role function preventive (4 items); and emotional function (3 items). Each item was scored on a 6-point scale ranging from 1 (none of the time) to 6 (all of the time). Raw domain scores were summed and transformed to a 0- to 100-point scale. Higher scores indicated better quality of life.
Change From Baseline in the Health-Related Quality of Life (EQ-5D-5L) Visual Analog Scale (VAS) Score at Week 12
The EQ-5D-5L is a participant-reported assessment designed to measure the participant's well-being. It consists of 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a VAS of the overall health state. Each descriptive item was rated on a 5-point index ranging from 1 (no problems) to 5 (extreme problems). The VAS ranged from 0 (worst imaginable health state) to 100 (best imaginable health state).
Change From Baseline in the MSQ Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Week 24
The MSQ is a participant-reported outcome designed to assess the quality of life in participants with migraine. It consists of 14 items covering 3 domains: role function restrictive (7 items); role function preventive (4 items); and emotional function (3 items). Each item was scored on a 6-point scale ranging from 1 (none of the time) to 6 (all of the time). Raw domain scores were summed and transformed to a 0- to 100-point scale. Higher scores indicated better quality of life.
Change From Baseline in the Health-Related Quality of Life (EQ-5D-5L) VAS Score at Week 24
The EQ-5D-5L is a participant-reported assessment designed to measure the participant's well-being. It consists of 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a VAS of the overall health state. Each descriptive item was rated on a 5-point index ranging from 1 (no problems) to 5 (extreme problems). The VAS ranged from 0 (worst imaginable health state) to 100 (best imaginable health state).
Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire Subscores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 12
The WPAI Questionnaire is a participant-reported instrument developed to measure the impact on work productivity and regular activities attributable to a specific health problem (migraine). Recall period is the past 7 days. It contains 6 items that measure: 1) employment status, 2) hours missed from work due to the specific health problem, 3) hours missed from work for other reasons, 4) hours actually worked, 5) degree health affected productivity while working, and 6) degree health affected productivity in regular unpaid activities. Four scores were calculated from the responses to these 6 items: absenteeism, presenteeism, work productivity loss, and activity impairment. Scores were calculated as impairment percentages (0-100%), with higher numbers indicating greater impairment and less productivity, i.e, worse outcomes.
Change From Baseline in the WPAI Questionnaire Subscores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 24
The WPAI Questionnaire is a participant-reported instrument developed to measure the impact on work productivity and regular activities attributable to a specific health problem (migraine). Recall period is the past 7 days. It contains 6 items that measure: 1) employment status, 2) hours missed from work due to the specific health problem, 3) hours missed from work for other reasons, 4) hours actually worked, 5) degree health affected productivity while working, and 6) degree health affected productivity in regular unpaid activities. Four scores were calculated from the responses to these 6 items: absenteeism, presenteeism, work productivity loss, and activity impairment. Scores were calculated as impairment percentages (0-100%), with higher numbers indicating greater impairment and less productivity, i.e, worse outcomes.
Percentage of Participants With ≥5-Point Reduction From Baseline to Week 12 in HIT-6 Score
The HIT-6 (version 1.0) is a Likert-type, self-reporting questionnaire designed to assess the impact of an occurring headache and its effect on the ability to function normally in daily life. The HIT-6 contains 6 questions, each item was rated from never to always with the following response scores: never = 6, rarely = 8, sometimes = 10, very often = 11, and always = 13. The total score for the HIT-6 was the sum of each response score ranging from 36 to 78. The life impact derived from the total score was described as followed: severe (≥60), substantial (56-59), some (50-55), little to none (≤49).
Percentage of Participants With ≥5-Point Reduction From Baseline to Week 24 in HIT-6 Score
The HIT-6 (version 1.0) is a Likert-type, self-reporting questionnaire designed to assess the impact of an occurring headache and its effect on the ability to function normally in daily life. The HIT-6 contains 6 questions, each item was rated from never to always with the following response scores: never = 6, rarely = 8, sometimes = 10, very often = 11, and always = 13. The total score for the HIT-6 was the sum of each response score ranging from 36 to 78. The life impact derived from the total score was described as followed: severe (≥60), substantial (56-59), some (50-55), little to none (≤49).
Health Care Resource Utilization (HCRU): Visits to a Family Doctor/General Practitioner
Number of participants who visited to a family doctor/general practitioner has been reported.
HCRU: Visits to a Specialist
Number of participants who visited to a specialist has been reported.
HCRU: Number of Emergency Department Visits Due to Your Migraine
Number of participants who visited to emergency department due to your migraine has been reported.
HCRU: Number of Hospital Admissions Due to Migraine
Number of participants who admitted in the hospital due to migraine has been reported.
HCRU: Total Number of Overnight Hospital Stays Due to Migraine
Number of participants who had total number of overnight hospital stays due to migraine has been reported.
Change From Baseline in the Number of MMDs Averaged Over Weeks 25 to 36, 37 to 48, 49 to 60, and 61 to 72
A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.
Percentage of Participants With ≥50% Reduction From Baseline in MMDs Averaged Over Weeks 25 to 36, 37 to 48, 49 to 60, and 61 to 72
A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.
Percentage of Participants With ≥75% Reduction From Baseline in MMDs Averaged Over Weeks 25 to 36, 37 to 48, 49 to 60, and 61 to 72
A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.
Change From Baseline in HIT-6 Score at Weeks 36, 48, 60, and 72
The HIT-6 (version 1.0) is a Likert-type, self-reporting questionnaire designed to assess the impact of an occurring headache and its effect on the ability to function normally in daily life. The HIT-6 contains 6 questions, each item was rated from never to always with the following response scores: never = 6, rarely = 8, sometimes = 10, very often = 11, and always = 13. The total score for the HIT-6 was the sum of each response score ranging from 36 to 78. The life impact derived from the total score was described as followed: severe (≥60), substantial (56-59), some (50-55), little to none (≤49).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04418765
Brief Title
A Study to Evaluate the Efficacy and Safety of Eptinezumab for the Prevention of Migraine in Participants That Are Not Helped by Previous Preventive Treatments
Acronym
DELIVER
Official Title
Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study With an Extension Period to Evaluate the Efficacy and Safety of Eptinezumab for the Prevention of Migraine in Patients With Unsuccessful Prior Preventive Treatments
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
July 15, 2021 (Actual)
Study Completion Date
September 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lundbeck A/S
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Evaluation of eptinezumab in the prevention of migraine in participants with unsuccessful prior preventive treatments.
Detailed Description
The total study duration from the screening visit to the completion visit is approximately 76 weeks and includes a screening period (28-30 days), a placebo-controlled treatment period (24 weeks) and a treatment extension period (48 weeks).
The participant will start treatment at the baseline visit and follow a 12-week dosing schedule with either eptinezumab (100 or 300 milligrams [mg]) or placebo by intraveneous (IV) infusion. Participants who were assigned to placebo in the placebo-controlled treatment period, will be randomly allocated to one of two treatment groups: eptinezumab 300 mg or eptinezumab 100 mg.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
892 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo matching to eptinezumab by IV infusion, every 12 weeks starting from Baseline (Day 0) through Week 24.
Arm Title
Eptinezumab 100 mg
Arm Type
Experimental
Arm Description
Participants will receive eptinezumab 100 mg by IV infusion, every 12 weeks starting from Baseline (Day 0) through Week 24.
Arm Title
Eptinezumab 300 mg
Arm Type
Experimental
Arm Description
Participants will receive eptinezumab 300 mg by IV infusion, every 12 weeks starting from Baseline (Day 0) through Week 24.
Intervention Type
Drug
Intervention Name(s)
Eptinezumab
Intervention Description
Eptinezumab, concentrate for solution for infusion 100 mg/milliliter (mL)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
concentrate for solution for infusion, intravenously
Primary Outcome Measure Information:
Title
Change From Baseline in the Number of Monthly Migraine Days (MMDs) Averaged Over Weeks 1 to 12
Description
A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.
Time Frame
Baseline, Weeks 1 - 12
Secondary Outcome Measure Information:
Title
Percentage of Participants With ≥50% Reduction From Baseline in MMDs Averaged Over Weeks 1 to 12
Description
A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.
Time Frame
Baseline to Weeks 1 - 12
Title
Change From Baseline in the Number of MMDs Averaged Over Weeks 13 to 24
Description
A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.
Time Frame
Baseline, Weeks 13 - 24
Title
Percentage of Participants With ≥75% Reduction From Baseline in MMDs Averaged Over Weeks 1 to 12
Description
A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.
Time Frame
Baseline to Weeks 1 - 12
Title
Change From Baseline in the Headache Impact Test (HIT-6) Score at Week 12
Description
The HIT-6 (version 1.0) is a Likert-type, self-reporting questionnaire designed to assess the impact of an occurring headache and its effect on the ability to function normally in daily life. The HIT-6 contains 6 questions, each item was rated from never to always with the following response scores: never = 6, rarely = 8, sometimes = 10, very often = 11, and always = 13. The total score for the HIT-6 was the sum of each response score ranging from 36 to 78. The life impact derived from the total score was described as followed: severe (≥60), substantial (56-59), some (50-55), little to none (≤49).
Time Frame
Baseline, Week 12
Title
Percentage of Participants With ≥50% Reduction From Baseline in MMDs Averaged Over Weeks 13 to 24
Description
A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.
Time Frame
Baseline to Weeks 13 - 24
Title
Percentage of Participants With ≥75% Reduction From Baseline in MMDs Averaged Over Weeks 13 to 24
Description
A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.
Time Frame
Baseline to Weeks 13 - 24
Title
Percentage of Participants With 100% Reduction From Baseline in MMDs Averaged Over Weeks 1 to 12
Description
A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.
Time Frame
Baseline to Weeks 1 - 12
Title
Percentage of Participants With ≥50% Reduction From Baseline in Monthly Headache Days (MHDs) Averaged Over Weeks 1 to 12
Description
A headache day was defined as a day with a headache that lasted ≥30 minutes or met the definition of a migraine day (as defined in criterion A, B, C, or D above in outcome measure 1).
Time Frame
Baseline to Weeks 1 - 12
Title
Percentage of Participants With ≥75% Reduction From Baseline in Monthly Headache Days (MHDs) Averaged Over Weeks 1 to 12
Description
A headache day was defined as a day with a headache that lasted ≥30 minutes or met the definition of a migraine day (as defined in criterion A, B, C, or D above in outcome measure 1).
Time Frame
Baseline to Weeks 1 - 12
Title
Percentage of Participants With 100% Reduction From Baseline in Monthly Headache Days (MHDs) Averaged Over Weeks 1 to 12
Description
A headache day was defined as a day with a headache that lasted ≥30 minutes or met the definition of a migraine day (as defined in criterion A, B, C, or D above in outcome measure 1).
Time Frame
Baseline to Weeks 1 - 12
Title
Change From Baseline in the Number of MHDs Averaged Over Weeks 1 to 12
Description
A headache day was defined as a day with a headache that lasted ≥30 minutes or met the definition of a migraine day (as defined in criterion A, B, C, or D above in outcome measure 1).
Time Frame
Baseline, Weeks 1 - 12
Title
Change From Baseline in the Percentage of Migraine Attacks With Severe Pain Intensity Averaged Over Weeks 1 to 12
Description
A migraine attack was defined as a headache that occurred on a single day or lasted >1 day and that met the criteria for a migraine day (as defined in criterion A, B, C, or D above in outcome measure 1).
Time Frame
Baseline, Weeks 1 - 12
Title
Change From Baseline in the Percentage of Headache Episodes With Severe Pain Intensity Averaged Over Weeks 1 to 12
Description
A headache episode was defined as a headache lasted ≥30 minutes or that met the criteria for a migraine (as defined in criterion A, B, C, or D above in outcome measure 1).
Time Frame
Baseline, Weeks 1 - 12
Title
Change From Baseline in the Number of Monthly Days With Use of Acute Migraine Medication Averaged Over Weeks 1 to 12
Description
In the evening eDiary, participants were asked each day to fill out whether they used any of the following medications during that day: Ergotamine, triptan, analgesic, opioid, or combination analgesic. A day where the participant answered that they took any of those in the evening eDiary was considered a day with use of acute migraine medication.
Time Frame
Baseline, Weeks 1 - 12
Title
Change From Baseline in the Number of Monthly Days With Use of Acute Migraine Medication Averaged Over Weeks 13 to 24
Description
In the evening eDiary, participants were asked each day to fill out whether they used any of the following medications during that day: Ergotamine, triptan, analgesic, opioid, or combination analgesic. A day where the participant answered that they took any of those in the evening eDiary was considered a day with use of acute migraine medication.
Time Frame
Baseline, Weeks 13- 24
Title
Change From Baseline in the Number of MMDs With Use of Acute Medication Averaged Over Weeks 1 to 12
Description
Number of MMDs with acute medication usage was derived using the answer to "Did you take any medications to treat this headache?" in the headache diary. The question was asked when a participant was ending a headache. Thus, a migraine day with acute medication usage was defined as a migraine day with the extra condition that this question was answered as "Yes".
Time Frame
Baseline, Weeks 1 - 12
Title
Change From Baseline in the Number of MMDs With Use of Acute Medication Averaged Over Weeks 13 to 24
Description
Number of MMDs with acute medication usage was derived using the answer to "Did you take any medications to treat this headache?" in the headache diary. The question was asked when a participant was ending a headache. Thus, a migraine day with acute medication usage was defined as a migraine day with the extra condition that this question was answered as "Yes".
Time Frame
Baseline, Weeks 13 - 24
Title
Patient Global Impression of Change (PGIC) Score at Week 12
Description
The PGIC is a single, participant-reported item reflecting the participant's impression of change in his/her disease status since the start of the study (that is, in relation to activity limitations, symptoms, emotions, and overall quality of life). Participants rated their impression of change in disease status on a 7-point scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse) where a higher score indicated worsening. Score ranges from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status.
Time Frame
Week 12
Title
PGIC Score at Week 24
Description
The PGIC is a single, participant-reported item reflecting the participant's impression of change in his/her disease status since the start of the study (that is, in relation to activity limitations, symptoms, emotions, and overall quality of life). Participants rated their impression of change in disease status on a 7-point scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse) where a higher score indicated worsening. Score ranges from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status.
Time Frame
Week 24
Title
Change From Baseline in the Number of MMDs in Participants With Medication Overuse Headache (MOH) Averaged Over Weeks 1 to 12
Time Frame
Baseline, Weeks 1 - 12
Title
Percentage of Participants With Migraine on the Day After First Dosing
Time Frame
Day 1
Title
Most Bothersome Symptom (MBS) Score at Week 12
Description
Participants were asked about their most bothersome symptom associated with their migraines during the Baseline Visit. Participants were asked to rate the improvement in this symptom from baseline on a 7-point scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse) where a high score indicated worsening. Score ranges from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status. The MBS areas included: nausea, vomiting, sensitivity to light, sensitivity to sound, mental cloudiness, fatigue, pain with activity, mood changes, and other symptoms.
Time Frame
Week 12
Title
Change From Baseline in the HIT-6 Score at Week 24
Description
The HIT-6 (version 1.0) is a Likert-type, self-reporting questionnaire designed to assess the impact of an occurring headache and its effect on the ability to function normally in daily life. The HIT-6 contains 6 questions, each item was rated from never to always with the following response scores: never = 6, rarely = 8, sometimes = 10, very often = 11, and always = 13. The total score for the HIT-6 was the sum of each response score ranging from 36 to 78. The life impact derived from the total score was described as followed: severe (≥60), substantial (56-59), some (50-55), little to none (≤49).
Time Frame
Baseline, Week 24
Title
Change From Baseline in the Migraine-Specific Quality of Life (MSQ) Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Week 12
Description
The MSQ is a participant-reported outcome designed to assess the quality of life in participants with migraine. It consists of 14 items covering 3 domains: role function restrictive (7 items); role function preventive (4 items); and emotional function (3 items). Each item was scored on a 6-point scale ranging from 1 (none of the time) to 6 (all of the time). Raw domain scores were summed and transformed to a 0- to 100-point scale. Higher scores indicated better quality of life.
Time Frame
Baseline, Week 12
Title
Change From Baseline in the Health-Related Quality of Life (EQ-5D-5L) Visual Analog Scale (VAS) Score at Week 12
Description
The EQ-5D-5L is a participant-reported assessment designed to measure the participant's well-being. It consists of 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a VAS of the overall health state. Each descriptive item was rated on a 5-point index ranging from 1 (no problems) to 5 (extreme problems). The VAS ranged from 0 (worst imaginable health state) to 100 (best imaginable health state).
Time Frame
Baseline, Week 12
Title
Change From Baseline in the MSQ Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Week 24
Description
The MSQ is a participant-reported outcome designed to assess the quality of life in participants with migraine. It consists of 14 items covering 3 domains: role function restrictive (7 items); role function preventive (4 items); and emotional function (3 items). Each item was scored on a 6-point scale ranging from 1 (none of the time) to 6 (all of the time). Raw domain scores were summed and transformed to a 0- to 100-point scale. Higher scores indicated better quality of life.
Time Frame
Baseline, Week 24
Title
Change From Baseline in the Health-Related Quality of Life (EQ-5D-5L) VAS Score at Week 24
Description
The EQ-5D-5L is a participant-reported assessment designed to measure the participant's well-being. It consists of 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a VAS of the overall health state. Each descriptive item was rated on a 5-point index ranging from 1 (no problems) to 5 (extreme problems). The VAS ranged from 0 (worst imaginable health state) to 100 (best imaginable health state).
Time Frame
Baseline, Week 24
Title
Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire Subscores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 12
Description
The WPAI Questionnaire is a participant-reported instrument developed to measure the impact on work productivity and regular activities attributable to a specific health problem (migraine). Recall period is the past 7 days. It contains 6 items that measure: 1) employment status, 2) hours missed from work due to the specific health problem, 3) hours missed from work for other reasons, 4) hours actually worked, 5) degree health affected productivity while working, and 6) degree health affected productivity in regular unpaid activities. Four scores were calculated from the responses to these 6 items: absenteeism, presenteeism, work productivity loss, and activity impairment. Scores were calculated as impairment percentages (0-100%), with higher numbers indicating greater impairment and less productivity, i.e, worse outcomes.
Time Frame
Baseline, Week 12
Title
Change From Baseline in the WPAI Questionnaire Subscores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 24
Description
The WPAI Questionnaire is a participant-reported instrument developed to measure the impact on work productivity and regular activities attributable to a specific health problem (migraine). Recall period is the past 7 days. It contains 6 items that measure: 1) employment status, 2) hours missed from work due to the specific health problem, 3) hours missed from work for other reasons, 4) hours actually worked, 5) degree health affected productivity while working, and 6) degree health affected productivity in regular unpaid activities. Four scores were calculated from the responses to these 6 items: absenteeism, presenteeism, work productivity loss, and activity impairment. Scores were calculated as impairment percentages (0-100%), with higher numbers indicating greater impairment and less productivity, i.e, worse outcomes.
Time Frame
Baseline, Week 24
Title
Percentage of Participants With ≥5-Point Reduction From Baseline to Week 12 in HIT-6 Score
Description
The HIT-6 (version 1.0) is a Likert-type, self-reporting questionnaire designed to assess the impact of an occurring headache and its effect on the ability to function normally in daily life. The HIT-6 contains 6 questions, each item was rated from never to always with the following response scores: never = 6, rarely = 8, sometimes = 10, very often = 11, and always = 13. The total score for the HIT-6 was the sum of each response score ranging from 36 to 78. The life impact derived from the total score was described as followed: severe (≥60), substantial (56-59), some (50-55), little to none (≤49).
Time Frame
Baseline to Week 12
Title
Percentage of Participants With ≥5-Point Reduction From Baseline to Week 24 in HIT-6 Score
Description
The HIT-6 (version 1.0) is a Likert-type, self-reporting questionnaire designed to assess the impact of an occurring headache and its effect on the ability to function normally in daily life. The HIT-6 contains 6 questions, each item was rated from never to always with the following response scores: never = 6, rarely = 8, sometimes = 10, very often = 11, and always = 13. The total score for the HIT-6 was the sum of each response score ranging from 36 to 78. The life impact derived from the total score was described as followed: severe (≥60), substantial (56-59), some (50-55), little to none (≤49).
Time Frame
Baseline to Week 24
Title
Health Care Resource Utilization (HCRU): Visits to a Family Doctor/General Practitioner
Description
Number of participants who visited to a family doctor/general practitioner has been reported.
Time Frame
Week 12
Title
HCRU: Visits to a Specialist
Description
Number of participants who visited to a specialist has been reported.
Time Frame
Week 12
Title
HCRU: Number of Emergency Department Visits Due to Your Migraine
Description
Number of participants who visited to emergency department due to your migraine has been reported.
Time Frame
Week 12
Title
HCRU: Number of Hospital Admissions Due to Migraine
Description
Number of participants who admitted in the hospital due to migraine has been reported.
Time Frame
Week 12
Title
HCRU: Total Number of Overnight Hospital Stays Due to Migraine
Description
Number of participants who had total number of overnight hospital stays due to migraine has been reported.
Time Frame
Week 12
Title
Change From Baseline in the Number of MMDs Averaged Over Weeks 25 to 36, 37 to 48, 49 to 60, and 61 to 72
Description
A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.
Time Frame
Baseline, Weeks 25 - 36, 37 - 48, 49 - 60, and 61 - 72
Title
Percentage of Participants With ≥50% Reduction From Baseline in MMDs Averaged Over Weeks 25 to 36, 37 to 48, 49 to 60, and 61 to 72
Description
A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.
Time Frame
Baseline to Weeks 25 - 36, 37 - 48, 49 - 60, and 61 - 72
Title
Percentage of Participants With ≥75% Reduction From Baseline in MMDs Averaged Over Weeks 25 to 36, 37 to 48, 49 to 60, and 61 to 72
Description
A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.
Time Frame
Baseline to Weeks 25 - 36, 37 - 48, 49 - 60, and 61 - 72
Title
Change From Baseline in HIT-6 Score at Weeks 36, 48, 60, and 72
Description
The HIT-6 (version 1.0) is a Likert-type, self-reporting questionnaire designed to assess the impact of an occurring headache and its effect on the ability to function normally in daily life. The HIT-6 contains 6 questions, each item was rated from never to always with the following response scores: never = 6, rarely = 8, sometimes = 10, very often = 11, and always = 13. The total score for the HIT-6 was the sum of each response score ranging from 36 to 78. The life impact derived from the total score was described as followed: severe (≥60), substantial (56-59), some (50-55), little to none (≤49).
Time Frame
Baseline, Weeks 36, 48, 60, and 72
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The participant has a diagnosis of migraine, with a history of chronic or episodic migraines of at least 12 months prior to the Screening Visit
The participant has a migraine onset of ≤50 years of age.
The participant has ≥4 migraine days per month for each month within the past 3 months prior to the Screening Visit.
The participant has demonstrated compliance with the Headache eDiary by entry of data for at least 24 of the 28 days following the Screening Visit.
The participant fulfils the following criteria for chronic migraine (CM) or episodic migraine (EM) in prospectively collected information in the eDiary during the screening period:
For participants with CM: Migraine occurring on ≥8 days and headache occurring on >14 days
For participants with EM: Migraine occurring on ≥4 days and headache occurring on ≤14 days
The participant has documented evidence of treatment failure (must be supported by medical record or by physician's confirmation specific to each treatment) in the past 10 years of 2-4 different migraine preventive medications.
The participant has a history of either previous or active use of triptans for migraine.
Exclusion Criteria:
The participant has experienced failure on a previous treatment targeting the calcitonin gene-related peptide (CGRP) pathway.
The participant has a treatment failure on valproate/divalproex or botulinum toxin A/B and the treatment is not the latest preventive medication prior to study inclusion. The medication is regarded as the latest if the medication start date is after the start date of the other preventive medications and the medication stop date is after the stop date of the other preventive medications.
The participant has confounding and clinically significant pain syndromes, (for example, fibromyalgia, chronic low back pain, complex regional pain syndrome).
The participant has a diagnosis of acute or active temporomandibular disorder.
The participant has a history or diagnosis of chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes such as hemiplegic migraine (sporadic and familial), ophthalmoplegic migraine, and migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration).
The participant has a psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit. Participants with a lifetime history of psychosis and/or mania in the last 5 years prior to the Screening Visit are excluded.
The participant has a history of clinically significant cardiovascular disease or vascular ischaemia or thromboembolic events (for example, cerebrovascular accident, deep vein thrombosis, or pulmonary embolism).
Other in- and exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Email contact via H. Lundbeck A/S
Organizational Affiliation
LundbeckClinicalTrials@Lundbeck.com
Official's Role
Study Director
Facility Information:
Facility Name
Diablo Clinical Research
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Sarkis Clinical Trials - Gainesville
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Accel Research Sites - Maitland
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Michigan Headache and Neurological Institute
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104-5131
Country
United States
Facility Name
Clinical Research Institute Inc. - Minneapolis
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55402
Country
United States
Facility Name
Albuqerque Clinical Trials
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Dent Neurologic Institute - Amherst
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
Country
United States
Facility Name
Integrative Clinical Trials
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11229
Country
United States
Facility Name
CTI Clinical Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
Hometown Urgent Care & Occupational Health/Hometown Research - Huber Heights
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45424
Country
United States
Facility Name
Lynn Health Science Institute - Oklahoma City
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Clinical Neuroscience Solutions - Memphis
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Northwest Clinical Research Center (NWCRC)
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
Northwest Neurological
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Universitair Ziekenhuis Brussel
City
Brussels
State/Province
Bruxelles-Capitale
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Jessa Ziekenhuis - Campus Virga Jesse
City
Hasselt
State/Province
Limburg
ZIP/Postal Code
3500
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan
City
Brugge
State/Province
West-Vlaanderen
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Multiprofile Hospital for Active Treatment in Neurology and Psychiatry Sveti Naum
City
Sofia
State/Province
Sofia City
ZIP/Postal Code
1113
Country
Bulgaria
Facility Name
First Multiprofile Hospital for Active Treatment - Sofia
City
Sofia
State/Province
Sofia City
ZIP/Postal Code
1142
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment Heart and Brain EAD
City
Pleven
ZIP/Postal Code
5804
Country
Bulgaria
Facility Name
Medical Center - Teodora EOOD
City
Ruse
ZIP/Postal Code
7012
Country
Bulgaria
Facility Name
Acibadem City Clinic Tokuda Hospital
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
Medical Center Medica Plus
City
Veliko Tarnovo
ZIP/Postal Code
5006
Country
Bulgaria
Facility Name
MUDr. Helena Hojdíkova s.r.o. Neurologicka Ambulance
City
Hradec Kralove
State/Province
Hradec Kralové
ZIP/Postal Code
500 03
Country
Czechia
Facility Name
Vestra Clinics
City
Rychnov nad Kneznou
State/Province
Hradec Kralové
ZIP/Postal Code
516 01
Country
Czechia
Facility Name
CCR Brno
City
Brno
State/Province
Jihormoravsky Kraj
ZIP/Postal Code
602 00
Country
Czechia
Facility Name
Fakultni nemocnice Ostrava
City
Ostrava-Poruba-Poruba
State/Province
Moravian-Silesian
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Fakultní Thomayerova nemocnice
City
Praha 4
State/Province
Prague
ZIP/Postal Code
140 59
Country
Czechia
Facility Name
Neurologicka Ambulance - Forbeli
City
Praha 6
State/Province
Prague
ZIP/Postal Code
160 00
Country
Czechia
Facility Name
Neuropsychiatrie S.R.O.
City
Praha 6
State/Province
Prague
ZIP/Postal Code
160 00
Country
Czechia
Facility Name
Institut Neuropsychiatrické Péce
City
Praha 8
State/Province
Prague
ZIP/Postal Code
186 00
Country
Czechia
Facility Name
CCR Prague
City
Praha 3
State/Province
Praha
ZIP/Postal Code
130 00
Country
Czechia
Facility Name
CCR Ostrava
City
Ostrava
State/Province
Severomoravsky Kraj
ZIP/Postal Code
702 00
Country
Czechia
Facility Name
Fakultní Nemocnice u sv. Anny v Brne
City
Brno
State/Province
South Moravian
ZIP/Postal Code
656 91
Country
Czechia
Facility Name
Nemocnice Jihlava
City
Jihlava
ZIP/Postal Code
586 01
Country
Czechia
Facility Name
Neurosanatio s.r.o
City
Litomyshl
ZIP/Postal Code
57001
Country
Czechia
Facility Name
Neurologie, MP-neuro s.r.o., poliklinika Modry pavilon
City
Slezska Ostrava
ZIP/Postal Code
710 00
Country
Czechia
Facility Name
NeuroMed Zlín s.r.o.
City
Zlín
ZIP/Postal Code
760 01
Country
Czechia
Facility Name
Rigshospitalet Glostrup
City
Glostrup
State/Province
Hovedstaden
ZIP/Postal Code
2600
Country
Denmark
Facility Name
Odense Universitetshospital
City
Odense
State/Province
Syddanmark
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Sydvestjysk Sygehus - Esbjerg
City
Esbjerg
ZIP/Postal Code
6700
Country
Denmark
Facility Name
Tampereen Yliopistollinen Sairaala
City
Tampere
State/Province
Länsi-Suomen Lääni
ZIP/Postal Code
33520
Country
Finland
Facility Name
Terveystalo Ruoholahti
City
Helsinki
State/Province
Southern Finland
ZIP/Postal Code
00180
Country
Finland
Facility Name
Terveystalo Turku Pulssi
City
Turku
State/Province
Western Finland
ZIP/Postal Code
20100
Country
Finland
Facility Name
Itä-Suomen Yliopisto - Kuopion Kampus
City
Kuopio
ZIP/Postal Code
70210
Country
Finland
Facility Name
Terveystalo Tampere
City
Tampere
ZIP/Postal Code
33100
Country
Finland
Facility Name
Hôpital Cimiez
City
Nice Cedex 1
State/Province
Côte-d'Or
ZIP/Postal Code
91179 - 06003
Country
France
Facility Name
Hôpital Charles-Nicolle
City
Rouen
State/Province
Haute-Normandie
ZIP/Postal Code
76000
Country
France
Facility Name
Hôpital Roger Salengro
City
Lille Cedex
State/Province
Nord
ZIP/Postal Code
59037
Country
France
Facility Name
Centre Hosptitalier Universitaire d'Angers
City
Angers
State/Province
Pays De La Loire
ZIP/Postal Code
49 933
Country
France
Facility Name
Assistance Publique Hôpitaux de Marseille
City
Marseille cedex 5
State/Province
Provence Alpes Cote D'Azure
ZIP/Postal Code
13 354
Country
France
Facility Name
Hôpital Pierre Wertheimer
City
Bron
State/Province
Rhone-Alps
ZIP/Postal Code
69500
Country
France
Facility Name
Helsicore - Israeli-Georgian Medical Research Clinic
City
T'bilisi
State/Province
Tbilisi
ZIP/Postal Code
0112
Country
Georgia
Facility Name
LLC Todua Clinic
City
T'bilisi
State/Province
Tbilisi
ZIP/Postal Code
0112
Country
Georgia
Facility Name
Pineo Medical Ecosystem
City
Tbilisi
ZIP/Postal Code
0114
Country
Georgia
Facility Name
Archangel Saint Michael Multiprofile Clinical Hospital
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
Aversi Clinic - Central Branch
City
Tbilisi
ZIP/Postal Code
0160
Country
Georgia
Facility Name
Mediclub Georgia Medical
City
Tbilisi
ZIP/Postal Code
0160
Country
Georgia
Facility Name
Jerarsi Clinic
City
Tbilisi
ZIP/Postal Code
0167
Country
Georgia
Facility Name
Malkhaz Katsiashvili Multiprofile Emergency Center
City
Tbilisi
ZIP/Postal Code
0172
Country
Georgia
Facility Name
Simon Khechinashvili University Hospital
City
Tbilisi
ZIP/Postal Code
0179
Country
Georgia
Facility Name
Consilium Medulla Multiprofile Clinic
City
Tbilisi
ZIP/Postal Code
0186
Country
Georgia
Facility Name
MVZ Dr. Roth & Kollegen GbR
City
Ostfildern
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
73760
Country
Germany
Facility Name
Neuroplus
City
Mannheim
State/Province
Baden-Württemberg
ZIP/Postal Code
68163
Country
Germany
Facility Name
NeuroConcept AG
City
Stuttgart
State/Province
Baden-Württemberg
ZIP/Postal Code
70182
Country
Germany
Facility Name
Praxis Dr. Steinwachs
City
Nürnberg
State/Province
Bayern
ZIP/Postal Code
90402
Country
Germany
Facility Name
CTC North
City
Hamburg
State/Province
Hamburg (Hansestadt)
ZIP/Postal Code
20251
Country
Germany
Facility Name
Migräne- und Kopfschmerzklinik Königstein
City
Königstein Im Taunus
State/Province
Hessen
ZIP/Postal Code
61462
Country
Germany
Facility Name
Synexus - Prüfzentrum Frankfurt/Main
City
Frankfurt am Main
State/Province
Hesse
ZIP/Postal Code
60313
Country
Germany
Facility Name
Studienzentrum Nord West
City
Westerstede
State/Province
Niedersachsen
ZIP/Postal Code
26655
Country
Germany
Facility Name
Neurozentrum Bielefeld
City
Bielefeld
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
33647
Country
Germany
Facility Name
Neurologische Praxis Dr. Stude
City
Bochum
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44787
Country
Germany
Facility Name
Praxis Astrid Gendolla
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45133
Country
Germany
Facility Name
Universitätsklinikum Essen
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Synexus - Leipzig
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
Facility Name
Synexus Clinical Research - Berlin
City
Berlin
ZIP/Postal Code
12627
Country
Germany
Facility Name
Neuropraxis München Süd
City
Unterhaching
ZIP/Postal Code
82008
Country
Germany
Facility Name
Valeomed Diagnosztikai Kozpont
City
Esztergom
State/Province
Komarom-Esztergom County
ZIP/Postal Code
2500
Country
Hungary
Facility Name
Pest Megyei Flor Ferenc Korhaz
City
Kistarcsa
State/Province
Pest
ZIP/Postal Code
2143
Country
Hungary
Facility Name
UNO Medical Trials Kft.
City
Budapest
ZIP/Postal Code
1152
Country
Hungary
Facility Name
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - San Raffaele Pisana
City
Rome
State/Province
Roma
ZIP/Postal Code
00163
Country
Italy
Facility Name
Universita Campus Bio-Medico di Roma
City
Roma
State/Province
Rome
ZIP/Postal Code
00128
Country
Italy
Facility Name
Azienda Ospedaliera - Universitaria Sant' Andrea
City
Roma
State/Province
Rome
ZIP/Postal Code
00189
Country
Italy
Facility Name
IRCCS Istituto Delle Scienze Neurologiche di Bologna
City
Bologna
ZIP/Postal Code
40139
Country
Italy
Facility Name
Azienda Ospedaliero - Universitaria Careggi
City
Florence
ZIP/Postal Code
50139
Country
Italy
Facility Name
Fondazione Mondino - Istituto Neurologico Nazionale a Carattere Scientifico IRCCS
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Centrum Medyczne Oporow
City
Wroclaw
State/Province
Dolnoslaskie
ZIP/Postal Code
52-416
Country
Poland
Facility Name
Centrum Medyczne Pratia - Bydgoszcz
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
85-796
Country
Poland
Facility Name
Prywatny Gabinet Lekarski Urszula Chyrchel-Paszkiewicz
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-093
Country
Poland
Facility Name
Indywidualna Praktyka Lekarska dr hab. n. med. Anna Szczepanska-Szerej
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-582
Country
Poland
Facility Name
Pratia MCM Krakow
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
30-510
Country
Poland
Facility Name
Specjalistyczne Gabinety Sp. z o.o.
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
30-539
Country
Poland
Facility Name
Instytut Zdrowia dr Boczarska-Jedynak
City
Oswiecim
State/Province
Malopolskie
ZIP/Postal Code
32-600
Country
Poland
Facility Name
Concept Medica Trials Prywatny Gabinet Lekarski Urszula Chyrchel-Paszkiewicz
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
00-773
Country
Poland
Facility Name
SOMED CR - Warsaw
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
01-737
Country
Poland
Facility Name
MTZ Clinical Research Powered by Pratia
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
01-868
Country
Poland
Facility Name
Synexus - Gdynia
City
Gdynia
State/Province
Pomorskie
ZIP/Postal Code
81-537
Country
Poland
Facility Name
Neuro-Care Katowice
City
Siemianowice Slaskie
State/Province
Silesia
ZIP/Postal Code
41-100
Country
Poland
Facility Name
Synexus - Czestochowa
City
Czestochowa
State/Province
Slaskie
ZIP/Postal Code
42-202
Country
Poland
Facility Name
Synexus - Katowice
City
Katowice
State/Province
Slaskie
ZIP/Postal Code
40-040
Country
Poland
Facility Name
Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska
City
Elblag
State/Province
Warminsko-Mazurskie
ZIP/Postal Code
82-300
Country
Poland
Facility Name
Centrum Medyczne Solumed
City
Poznan
State/Province
Wielkopolskie
ZIP/Postal Code
60-529
Country
Poland
Facility Name
Synexus - Poznan
City
Poznan
State/Province
Wielkopolskie
ZIP/Postal Code
60-702
Country
Poland
Facility Name
Centrum Medyczne Pratia - Czestochowa
City
Czestochowa
ZIP/Postal Code
42-200
Country
Poland
Facility Name
SOMED CR - Lodz
City
Lodz
ZIP/Postal Code
90-368
Country
Poland
Facility Name
University Headache Clinic
City
Moscow
ZIP/Postal Code
121467
Country
Russian Federation
Facility Name
Neurologicka ambulancia MUDr. Dupejova s.r.o.
City
Banska Bystrica
ZIP/Postal Code
97404
Country
Slovakia
Facility Name
In Medic
City
Bardejov
ZIP/Postal Code
8501
Country
Slovakia
Facility Name
MEDBAJ s.r.o.
City
Dolny Kubin
ZIP/Postal Code
026 01
Country
Slovakia
Facility Name
Medicínske Centrum Konzílium - Dubnica nad Vahom
City
Dubnica nad Vahom
ZIP/Postal Code
01841
Country
Slovakia
Facility Name
Hospital Universitario de Basurto
City
Bilbao
State/Province
Biscay
ZIP/Postal Code
48013
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro - Majadahonda
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital Universitario Quironsalud Madrid
City
Pozuelo de Alarcon
State/Province
Madrid
ZIP/Postal Code
28223
Country
Spain
Facility Name
Clinica Universidad de Navarra - Pamplona
City
Pamplona
State/Province
Navarre
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Alvaro Cunqueiro - Clinico Universitario Vigo
City
Vigo
State/Province
Pontevedra
ZIP/Postal Code
36213
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocío
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Clínico Universitario de Valladolid
City
Valladolid
ZIP/Postal Code
47003
Country
Spain
Facility Name
Hospital Clínico Universitario de Valencia
City
València
ZIP/Postal Code
46010
Country
Spain
Facility Name
Hospital Clinico Universitario Lozano Blesa
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Migränkliniken Europa AB
City
Värnamo
State/Province
Kronoborgs Län
ZIP/Postal Code
331 50
Country
Sweden
Facility Name
Stortorgets neurologmottagning
City
Helsingborg
State/Province
Skåne Län
ZIP/Postal Code
25220
Country
Sweden
Facility Name
Centralsjukhuset Kristianstad
City
Kristianstad
State/Province
Skåne Län
ZIP/Postal Code
291 85
Country
Sweden
Facility Name
Universitetssjukhuset i Linköping
City
Linkoeping
State/Province
Östergötlands Län
ZIP/Postal Code
581 85
Country
Sweden
Facility Name
Synexus - Scotland Clinical Research Centre
City
Bellshill
State/Province
England
ZIP/Postal Code
ML4 3NJ
Country
United Kingdom
Facility Name
Synexus - The Lancashire Clinic
City
Chorley
State/Province
England
ZIP/Postal Code
PR7 7NA
Country
United Kingdom
Facility Name
Synexus Midlands Clinical Research Centre
City
Edgbaston
State/Province
England
ZIP/Postal Code
B15 2SQ
Country
United Kingdom
Facility Name
Synexus - The Hexham Clinic
City
Hexham
State/Province
England
ZIP/Postal Code
NE46 1QJ
Country
United Kingdom
Facility Name
Synexus - Merseyside Clinical Research Centre
City
Liverpool
State/Province
England
ZIP/Postal Code
L22 0LG
Country
United Kingdom
Facility Name
Panthera Biopartners - North London
City
London
State/Province
England
ZIP/Postal Code
EN3 4GS
Country
United Kingdom
Facility Name
Synexus - Manchester Clinical Research Centre
City
Manchester
State/Province
England
ZIP/Postal Code
M15 6SE
Country
United Kingdom
Facility Name
Panthera Biopartners - Manchester
City
Manchester
State/Province
England
ZIP/Postal Code
OL11 4AU
Country
United Kingdom
Facility Name
Panthera Biopartners - Preston
City
Preston
State/Province
England
ZIP/Postal Code
PR2 9QB
Country
United Kingdom
Facility Name
Synexus - Thames Valley Clinical Research Centre
City
Reading
State/Province
England
ZIP/Postal Code
RG2 0TG
Country
United Kingdom
Facility Name
Northern Care Alliance NHS Foundation Trust
City
Salford
State/Province
England
ZIP/Postal Code
M6 8HD
Country
United Kingdom
Facility Name
Synexus - Wales
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF15 9SS
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
35716692
Citation
Ashina M, Lanteri-Minet M, Pozo-Rosich P, Ettrup A, Christoffersen CL, Josiassen MK, Phul R, Sperling B. Safety and efficacy of eptinezumab for migraine prevention in patients with two-to-four previous preventive treatment failures (DELIVER): a multi-arm, randomised, double-blind, placebo-controlled, phase 3b trial. Lancet Neurol. 2022 Jul;21(7):597-607. doi: 10.1016/S1474-4422(22)00185-5.
Results Reference
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Learn more about this trial
A Study to Evaluate the Efficacy and Safety of Eptinezumab for the Prevention of Migraine in Participants That Are Not Helped by Previous Preventive Treatments
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