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A Study of Eptinezumab in Participants With Migraine and Medication Overuse Headache

Primary Purpose

Migraine, Medication Overuse Headache

Status
Recruiting
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Eptinezumab
Placebo
Sponsored by
H. Lundbeck A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Migraine focused on measuring Eptinezumab, Migraine, Medication overuse headache, Brief educational intervention

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The participant has a diagnosis of migraine or MOH as defined by IHS ICHD-3 guidelines confirmed at the Screening Visit.
  • The participant has ≥8 migraine days per month for each month within the past 3 months prior to the Screening Visit.
  • The participant has ≥15 headache days per month for each month within the past 3 months prior to the Screening Visit.
  • The participant has had an onset of migraine diagnosis at ≤50 years of age.

Exclusion Criteria:

  • The participant has confounding and clinically significant pain syndromes (for example, fibromyalgia, chronic low back pain, and complex regional pain syndrome).
  • The participant has a diagnosis of acute or active temporomandibular disorders.
  • 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), recurrent painful ophthalmoplegic neuropathy, migraine with brainstem aura, and migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration).
  • The participant has psychosis, bipolar mania, dementia, or any other psychiatric conditions whose symptoms are not controlled or who has not been adequately treated for a minimum of 6 months prior to the Screening Visit.
  • The participant has a history of clinically significant cardiovascular disease including uncontrolled hypertension, vascular ischaemia, or thromboembolic events (for example, cerebrovascular accident, deep vein thrombosis, or pulmonary embolism).

Other inclusion and exclusion criteria may apply.

Sites / Locations

  • Clinical Research of Central Florida - ClinEdge - PPDSRecruiting
  • Legacy Clinical Solutions: Tandem Clinical Research, LLC - ClinEdge - Louisiana - PPDS
  • Clinvest - National Ave - Headlands - PPDS
  • Dent Neurologic InstituteRecruiting
  • Montefiore Headache Center - BRANY - PPDSRecruiting
  • Texas Center for Drug Development, Inc
  • Southern NeurologyRecruiting
  • Mater Adult HospitalRecruiting
  • Austin HospitalRecruiting
  • Alfred HealthRecruiting
  • Royal Melbourne HospitalRecruiting
  • Danish Headache CenterRecruiting
  • Sydvestjysk Sygehus EsbjergRecruiting
  • CHU de NiceRecruiting
  • Assistance Publique Hopitaux de MarseilleRecruiting
  • Hôpital Pierre-Paul RiquetRecruiting
  • Centre Hospitalier D'annecyRecruiting
  • CHRU NantesRecruiting
  • Centre Hospitalier Universitaire de Saint EtienneRecruiting
  • Hôpital Roger SalengroRecruiting
  • Centre Hospitalier Universitaire de Clermont Ferrand -Clermont-Ferrand -58 Rue MontalembertRecruiting
  • Hôpital Pierre WertheimerRecruiting
  • Hopital LariboisiereRecruiting
  • Groupe Hospitalier Paris Saint JosephRecruiting
  • Sindelfingen ClinicsRecruiting
  • Kopfschmerzzentrum FrankfurtRecruiting
  • Studienzentrum Nord-WestRecruiting
  • Praxis fuer Neurologie, Spezielle Schmerztherapie und Psychotherapie
  • Universitätsklinikum EssenRecruiting
  • Universitätsklinikum Carl Gustav Carus an der TU DresdenRecruiting
  • Universitatsklinikum Jena - Am Klinikum 1-Erlanger Allee 101Recruiting
  • Universitätsmedizin GreifswaldRecruiting
  • ASL 1 Abruzzo - PO AvezzanoRecruiting
  • AOU dell'Universita degli Studi della Campania Luigi Vanvitelli - Piazza Luigi Miraglia, 2Recruiting
  • IRCCS Istituto delle Scienze Neurologiche di BolognaRecruiting
  • Fondazione Policlinico Universitario Campus Bio-Medico di RomaRecruiting
  • Fondazione Policlinico Universitario A Gemelli-RomeRecruiting
  • Ospedale San Raffaele S.r.l. - PPDSRecruiting
  • Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta-Via Celoria, 11Recruiting
  • Azienda Ospedaliero Universitaria Consorziale Policlinico di BariRecruiting
  • Azienda Ospedaliera Universitaria CareggiRecruiting
  • Ospedale Santa Maria Della Misericordia Di PerugiaRecruiting
  • Azienda Ospedaliero Universitaria Di Modena PoliclinicoRecruiting
  • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone-Piazza Delle Cliniche 2Recruiting
  • Fondazione Istituto Neurologico Mondino IRCCSRecruiting
  • Leids Universitair Medisch CentrumRecruiting
  • Akershus UniversitetssykehusRecruiting
  • Haukeland UniversitetssykehusRecruiting
  • St. Olav's University HospitalRecruiting
  • Oslo UniversitetssykehusRecruiting
  • Hospital Universitario Puerta de Hierro - MajadahondaRecruiting
  • Hospital General Universitario Dr. BalmisRecruiting
  • Hospital Clinic de BarcelonaRecruiting
  • Hospital de La Santa Creu i Sant Pau
  • Hospital Universitario Vall d'Hebron - PPDSRecruiting
  • Hospital Puerta del MarRecruiting
  • C.H. Regional Reina Sofia - PPDSRecruiting
  • Hospital Universitari Arnau de VilanovaRecruiting
  • Hospital Universitario Fundacion Jimenez DiazRecruiting
  • Hospital Universitario HM Sanchinarro - CIOCCRecruiting
  • Hospital Universitario Virgen del Rocio - PPDSRecruiting
  • Hospital Universitari i Politecnic La Fe de ValenciaRecruiting
  • Hospital Clinico Universitario de ValladolidRecruiting
  • Hospital Clinico Universitario Lozano BlesaRecruiting
  • Skaneuro PrivatmottagningRecruiting
  • Karolinska Universitetssjukhuset HuddingeRecruiting
  • CTC Clinical Trial Consultants ABRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Eptinezumab

Placebo

Arm Description

Participants will receive an intravenous (IV) infusion of eptinezumab at Week 0 and Week 12.

Participants will receive a single IV infusion of matching placebo to eptinezumab at Week 0. Then, all participants will receive a single IV infusion of eptinezumab at Week 12.

Outcomes

Primary Outcome Measures

Change From Baseline in the Number of Monthly Migraine Days (MMDs)

Secondary Outcome Measures

Change From Baseline in MMDs
Change From Baseline in the Number of Monthly Headache Days (MHDs)
Change From Baseline in Average Daily Pain Assessment Score
Change From Baseline in Monthly Days with Acute Medication Use
Percentage of Participants Not Fulfilling the International Classification of Headache Disorders (ICHD-3) Diagnostic Criteria for Chronic Migraine (CM)
Percentage of Participants Not Fulfilling the ICHD-3 Diagnostic Criteria for MOH
Change From Baseline in MMDs with Acute Medication Use
Change from Baseline in Monthly Days of Medication Use (triptans, ergotamine, non-opioids, opioids, and combination analgesics)
Percentage of Participants with Migraine on the Day After Dosing
Response: ≥50% Reduction From Baseline in MMDs
Response: ≥75% Reduction From Baseline in MMDs
Response: ≥50% Reduction From Baseline in MHDs
Response: ≥75% Reduction From Baseline in MHDs
Change from Baseline in Rate of Migraines and Headaches with Severe Pain Intensity
Patient Global Impression of Change (PGIC) Score
The PGIC is a patient-reported measure of improvement in pain sensation and quality of life scored on a scale from 1 (very much improved) to 7 (very much worse).
Change in Most Bothersome Symptom (MBS) Score
Participants will identify a migraine-related symptom that is most bothersome for them. Participants will be asked to rate the improvement in this symptom from screening on a 7-point scale. The pre-specified bothersome items are: nausea, vomiting, sensitivity to light, sensitivity to sound.
Change From Baseline in the Headache Impact Test (HIT-6) Total Score
The HIT-6 (v1.0) is a 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 is 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 is the sum of each response score and ranges from 36 to 78. The life impact derived from the total score is described as followed: Severe (≥60), Substantial (56 59), Some (50-55), Little to None (≤49).
Change From Baseline in the Migraine Disability Assessment (mMIDAS) Total Score
The mMIDAS is a self-reporting questionnaire designed to assess absenteeism (complete disability) and presenteeism (reduced participation) in several domains, including work, school, family, social, and leisure activities. The total number of days with disability is rated on a 4-point scale, from the lower total score that indicates a Little or No Disability; Mild Disability; Moderate Disability to the higher total score that indicates a Severe Disability.
Change From Baseline in the Migraine-Specific Quality of Life (MSQ v2.1) Sub-Scores
The MSQ v2.1 is 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 is scored on a 6-point scale ranging from 1 (none of the time) to 6 (all of the time). Raw domain scores are summed and transformed to a 0-to-100-point scale. Higher scores indicate better quality of life. Sub-scores: Role Function-Restrictive, Role Function-Preventive, Emotional Function)
Change From Baseline in the Health-Related Quality of Life (EQ-5D-5L) Visual Analogue Scale (VAS) Score
The EQ-5D-5L42 is a patient-reported assessment designed to measure the participant's wellbeing. 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 is rated on a 5-point index ranging from 1 (no problems) to 5 (extreme problems) and a single summary index (from 0 to 1) can be calculated. The VAS ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).
Change From Baseline in Health Care Resources Utilisation (HCRU) Score
Migraine-specific health care resource utilization information will be collected in terms of outpatient health care professional visits, emergency room visits, hospital admissions, as well as duration of hospital stays.
Change From Baseline in Work Productivity as Measured Using the Work Productivity and Activity Impairment Questionnaire (WPAI) Sub-Scores
The WPAI is designed to provide a quantitative measure of the work productivity and activity impairment due to a specific health problem (WPAI:M). The WPAI:M assesses activities over the preceding 7 days and consists of 6 items: 1 item assess employment status, 3 items assess the number of hours worked, the number of hours missed from work due to the participant's condition, or due to other reasons, and 2 visual numerical scales to assess how much the participant's condition affects their productivity at work and their ability to complete normal daily activities. Sub-scores: (Absenteeism, Presenteeism, Work productivity loss, Activity impairment)
Change From Baseline in Hospital Anxiety and Depression (HADS) Sub-Scores
The HADS is a patient-rated scale designed to screen for anxiety and depressive states in non-psychiatric participants. The HADS consists of two sub-scales: the D-scale measures depression and the A-scale measures anxiety. Each sub-scale contains 7 items, and each item is rated from 0 (absent) to 3 (maximum severity). The score of each sub-scale ranges from 0 to 21 and are analysed separately.
Change From Baseline in Treatment Satisfaction Questionnaire for Medicine (9 Items) (TSQM-9) Score
The TSQM-9 is a generic questionnaire assessing the participants satisfaction with the medication. The tool consists of 9 items addressing effectiveness, side effects, convenience, and overall satisfaction of the study drug.

Full Information

First Posted
July 6, 2022
Last Updated
October 5, 2023
Sponsor
H. Lundbeck A/S
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1. Study Identification

Unique Protocol Identification Number
NCT05452239
Brief Title
A Study of Eptinezumab in Participants With Migraine and Medication Overuse Headache
Official Title
Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of add-on Eptinezumab Treatment to Brief Educational Intervention for the Preventive Treatment of Migraine in Patients With Dual Diagnosis of Migraine and Medication Overuse Headache
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
May 30, 2024 (Anticipated)
Study Completion Date
May 30, 2024 (Anticipated)

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

5. Study Description

Brief Summary
Medication overuse headache (MOH) is a type of headache caused by excessive use of acute headache or migraine medications (medications used to treat a headache or migraine once it begins). Treatment of MOH usually involves reducing the dose of or discontinuing acute medications. Eptinezumab is a medication used for the preventive treatment of migraine in adults. The main goals of this trial are to learn whether eptinezumab helps reduce the number of days with migraine, the number of days with headache, and acute medication use in adults who have migraine and MOH.
Detailed Description
The total study duration from screening visit to safety follow-up visit is approximately 36 weeks and includes a screening period (4 weeks), a placebo-controlled period (12 weeks), an open-label period (12 weeks), and a safety follow-up period (8 weeks).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine, Medication Overuse Headache
Keywords
Eptinezumab, Migraine, Medication overuse headache, Brief educational intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
570 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Eptinezumab
Arm Type
Experimental
Arm Description
Participants will receive an intravenous (IV) infusion of eptinezumab at Week 0 and Week 12.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive a single IV infusion of matching placebo to eptinezumab at Week 0. Then, all participants will receive a single IV infusion of eptinezumab at Week 12.
Intervention Type
Drug
Intervention Name(s)
Eptinezumab
Intervention Description
Solution for infusion
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Solution for infusion
Primary Outcome Measure Information:
Title
Change From Baseline in the Number of Monthly Migraine Days (MMDs)
Time Frame
Baseline to Weeks 1-4
Secondary Outcome Measure Information:
Title
Change From Baseline in MMDs
Time Frame
Weeks 1-12 and Weeks 13-24
Title
Change From Baseline in the Number of Monthly Headache Days (MHDs)
Time Frame
Weeks 1-4, Weeks 1-12, and Weeks 13-24
Title
Change From Baseline in Average Daily Pain Assessment Score
Time Frame
Weeks 1-2, Weeks 13-24
Title
Change From Baseline in Monthly Days with Acute Medication Use
Time Frame
Weeks 1-4, Weeks 1-12, and Weeks 13-24
Title
Percentage of Participants Not Fulfilling the International Classification of Headache Disorders (ICHD-3) Diagnostic Criteria for Chronic Migraine (CM)
Time Frame
Weeks 1-4, Weeks 1-12, and Weeks 13-24
Title
Percentage of Participants Not Fulfilling the ICHD-3 Diagnostic Criteria for MOH
Time Frame
Weeks 1-4, Weeks 1-12, and Weeks 13-24
Title
Change From Baseline in MMDs with Acute Medication Use
Time Frame
Weeks 1-12 and Weeks 13-24
Title
Change from Baseline in Monthly Days of Medication Use (triptans, ergotamine, non-opioids, opioids, and combination analgesics)
Time Frame
Weeks 1-12 and Weeks 13-24
Title
Percentage of Participants with Migraine on the Day After Dosing
Time Frame
On the day after dosing
Title
Response: ≥50% Reduction From Baseline in MMDs
Time Frame
Baseline to Weeks 1-4 and Weeks 1-12
Title
Response: ≥75% Reduction From Baseline in MMDs
Time Frame
Baseline to Weeks 1-4 and Weeks 1-12
Title
Response: ≥50% Reduction From Baseline in MHDs
Time Frame
Baseline to Weeks 1-4 and Weeks 1-12
Title
Response: ≥75% Reduction From Baseline in MHDs
Time Frame
Baseline to Weeks 1-4 and Weeks 1-12
Title
Change from Baseline in Rate of Migraines and Headaches with Severe Pain Intensity
Time Frame
Weeks 1-4 and Weeks 1-12
Title
Patient Global Impression of Change (PGIC) Score
Description
The PGIC is a patient-reported measure of improvement in pain sensation and quality of life scored on a scale from 1 (very much improved) to 7 (very much worse).
Time Frame
Week 4, Week 12, and Week 24
Title
Change in Most Bothersome Symptom (MBS) Score
Description
Participants will identify a migraine-related symptom that is most bothersome for them. Participants will be asked to rate the improvement in this symptom from screening on a 7-point scale. The pre-specified bothersome items are: nausea, vomiting, sensitivity to light, sensitivity to sound.
Time Frame
Weeks 1-12 and Weeks 13-24
Title
Change From Baseline in the Headache Impact Test (HIT-6) Total Score
Description
The HIT-6 (v1.0) is a 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 is 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 is the sum of each response score and ranges from 36 to 78. The life impact derived from the total score is described as followed: Severe (≥60), Substantial (56 59), Some (50-55), Little to None (≤49).
Time Frame
Week 4, Week 12, and Week 24
Title
Change From Baseline in the Migraine Disability Assessment (mMIDAS) Total Score
Description
The mMIDAS is a self-reporting questionnaire designed to assess absenteeism (complete disability) and presenteeism (reduced participation) in several domains, including work, school, family, social, and leisure activities. The total number of days with disability is rated on a 4-point scale, from the lower total score that indicates a Little or No Disability; Mild Disability; Moderate Disability to the higher total score that indicates a Severe Disability.
Time Frame
Baseline to Week 4, Week 12, and Week 24
Title
Change From Baseline in the Migraine-Specific Quality of Life (MSQ v2.1) Sub-Scores
Description
The MSQ v2.1 is 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 is scored on a 6-point scale ranging from 1 (none of the time) to 6 (all of the time). Raw domain scores are summed and transformed to a 0-to-100-point scale. Higher scores indicate better quality of life. Sub-scores: Role Function-Restrictive, Role Function-Preventive, Emotional Function)
Time Frame
Baseline to Week 4, Week 12, and Week 24
Title
Change From Baseline in the Health-Related Quality of Life (EQ-5D-5L) Visual Analogue Scale (VAS) Score
Description
The EQ-5D-5L42 is a patient-reported assessment designed to measure the participant's wellbeing. 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 is rated on a 5-point index ranging from 1 (no problems) to 5 (extreme problems) and a single summary index (from 0 to 1) can be calculated. The VAS ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).
Time Frame
Baseline to Week 4, Week 12, and Week 24
Title
Change From Baseline in Health Care Resources Utilisation (HCRU) Score
Description
Migraine-specific health care resource utilization information will be collected in terms of outpatient health care professional visits, emergency room visits, hospital admissions, as well as duration of hospital stays.
Time Frame
Baseline to Week 12 and Week 24
Title
Change From Baseline in Work Productivity as Measured Using the Work Productivity and Activity Impairment Questionnaire (WPAI) Sub-Scores
Description
The WPAI is designed to provide a quantitative measure of the work productivity and activity impairment due to a specific health problem (WPAI:M). The WPAI:M assesses activities over the preceding 7 days and consists of 6 items: 1 item assess employment status, 3 items assess the number of hours worked, the number of hours missed from work due to the participant's condition, or due to other reasons, and 2 visual numerical scales to assess how much the participant's condition affects their productivity at work and their ability to complete normal daily activities. Sub-scores: (Absenteeism, Presenteeism, Work productivity loss, Activity impairment)
Time Frame
Baseline to Week 12 and Week 24
Title
Change From Baseline in Hospital Anxiety and Depression (HADS) Sub-Scores
Description
The HADS is a patient-rated scale designed to screen for anxiety and depressive states in non-psychiatric participants. The HADS consists of two sub-scales: the D-scale measures depression and the A-scale measures anxiety. Each sub-scale contains 7 items, and each item is rated from 0 (absent) to 3 (maximum severity). The score of each sub-scale ranges from 0 to 21 and are analysed separately.
Time Frame
Baseline to Week 12 and Week 24
Title
Change From Baseline in Treatment Satisfaction Questionnaire for Medicine (9 Items) (TSQM-9) Score
Description
The TSQM-9 is a generic questionnaire assessing the participants satisfaction with the medication. The tool consists of 9 items addressing effectiveness, side effects, convenience, and overall satisfaction of the study drug.
Time Frame
Baseline to Week 4, Week 12, and Week 24

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 or MOH as defined by IHS ICHD-3 guidelines confirmed at the Screening Visit. The participant has ≥8 migraine days per month for each month within the past 3 months prior to the Screening Visit. The participant has ≥15 headache days per month for each month within the past 3 months prior to the Screening Visit. The participant has had an onset of migraine diagnosis at ≤50 years of age. Exclusion Criteria: The participant has confounding and clinically significant pain syndromes (for example, fibromyalgia, chronic low back pain, and complex regional pain syndrome). The participant has a diagnosis of acute or active temporomandibular disorders. 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), recurrent painful ophthalmoplegic neuropathy, migraine with brainstem aura, and migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration). The participant has psychosis, bipolar mania, dementia, or any other psychiatric conditions whose symptoms are not controlled or who has not been adequately treated for a minimum of 6 months prior to the Screening Visit. The participant has a history of clinically significant cardiovascular disease including uncontrolled hypertension, vascular ischaemia, or thromboembolic events (for example, cerebrovascular accident, deep vein thrombosis, or pulmonary embolism). Other inclusion and exclusion criteria may apply.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Email contact via H. Lundbeck A/S
Phone
+45 36301311
Email
LundbeckClinicalTrials@Lundbeck.com
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
Clinical Research of Central Florida - ClinEdge - PPDS
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880-3053
Country
United States
Individual Site Status
Recruiting
Facility Name
Legacy Clinical Solutions: Tandem Clinical Research, LLC - ClinEdge - Louisiana - PPDS
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072-3083
Country
United States
Individual Site Status
Completed
Facility Name
Clinvest - National Ave - Headlands - PPDS
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807-6012
Country
United States
Individual Site Status
Completed
Facility Name
Dent Neurologic Institute
City
Amherst
State/Province
New York
ZIP/Postal Code
14226-1727
Country
United States
Individual Site Status
Recruiting
Facility Name
Montefiore Headache Center - BRANY - PPDS
City
Bronx
State/Province
New York
ZIP/Postal Code
10461-2732
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Center for Drug Development, Inc
City
Houston
State/Province
Texas
ZIP/Postal Code
77081
Country
United States
Individual Site Status
Completed
Facility Name
Southern Neurology
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Individual Site Status
Recruiting
Facility Name
Mater Adult Hospital
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Individual Site Status
Recruiting
Facility Name
Austin Hospital
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Individual Site Status
Recruiting
Facility Name
Alfred Health
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Individual Site Status
Recruiting
Facility Name
Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Individual Site Status
Recruiting
Facility Name
Danish Headache Center
City
Glostrup
State/Province
Capital
ZIP/Postal Code
2600
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Sydvestjysk Sygehus Esbjerg
City
Esbjerg
ZIP/Postal Code
6700
Country
Denmark
Individual Site Status
Recruiting
Facility Name
CHU de Nice
City
Nice
State/Province
Alpes-Maritimes
ZIP/Postal Code
06000
Country
France
Individual Site Status
Recruiting
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
State/Province
Bouches-du-Rhône
ZIP/Postal Code
13385
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpital Pierre-Paul Riquet
City
Toulouse
State/Province
Haute-Garonne
ZIP/Postal Code
31000
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier D'annecy
City
Pringy
State/Province
Haute-Savoie
ZIP/Postal Code
74374
Country
France
Individual Site Status
Recruiting
Facility Name
CHRU Nantes
City
Saint-Herblain
State/Province
Loire-Atlantique
ZIP/Postal Code
44800
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire de Saint Etienne
City
Saint-Priest-en-Jarez
State/Province
Loire
ZIP/Postal Code
42055
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpital Roger Salengro
City
Lille
State/Province
Nord
ZIP/Postal Code
59000
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire de Clermont Ferrand -Clermont-Ferrand -58 Rue Montalembert
City
Clermont-Ferrand
State/Province
Puy-de-Dôme
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpital Pierre Wertheimer
City
Bron
State/Province
Rhône
ZIP/Postal Code
69500
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Lariboisiere
City
Paris
ZIP/Postal Code
75010
Country
France
Individual Site Status
Recruiting
Facility Name
Groupe Hospitalier Paris Saint Joseph
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Name
Sindelfingen Clinics
City
Sindelfingen
State/Province
Baden-Württemberg
ZIP/Postal Code
71065
Country
Germany
Individual Site Status
Recruiting
Facility Name
Kopfschmerzzentrum Frankfurt
City
Frankfurt am Main
State/Province
Hessen
ZIP/Postal Code
65929
Country
Germany
Individual Site Status
Recruiting
Facility Name
Studienzentrum Nord-West
City
Westerstede
State/Province
Niedersachsen
ZIP/Postal Code
26655
Country
Germany
Individual Site Status
Recruiting
Facility Name
Praxis fuer Neurologie, Spezielle Schmerztherapie und Psychotherapie
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45133
Country
Germany
Individual Site Status
Completed
Facility Name
Universitätsklinikum Essen
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45147
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Carl Gustav Carus an der TU Dresden
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitatsklinikum Jena - Am Klinikum 1-Erlanger Allee 101
City
Jena
State/Province
Thüringen
ZIP/Postal Code
07747
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsmedizin Greifswald
City
Greifswald
ZIP/Postal Code
17475
Country
Germany
Individual Site Status
Recruiting
Facility Name
ASL 1 Abruzzo - PO Avezzano
City
Avezzano
State/Province
Abruzzo
ZIP/Postal Code
67051
Country
Italy
Individual Site Status
Recruiting
Facility Name
AOU dell'Universita degli Studi della Campania Luigi Vanvitelli - Piazza Luigi Miraglia, 2
City
Napoli
State/Province
Campania
ZIP/Postal Code
80138
Country
Italy
Individual Site Status
Recruiting
Facility Name
IRCCS Istituto delle Scienze Neurologiche di Bologna
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40139
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione Policlinico Universitario Campus Bio-Medico di Roma
City
Roma
State/Province
Lazio
ZIP/Postal Code
00128
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione Policlinico Universitario A Gemelli-Rome
City
Roma
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale San Raffaele S.r.l. - PPDS
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20127
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta-Via Celoria, 11
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20133
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
City
Bari
State/Province
Puglia
ZIP/Postal Code
70124
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera Universitaria Careggi
City
Firenze
State/Province
Toscana
ZIP/Postal Code
50134
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale Santa Maria Della Misericordia Di Perugia
City
Perugia
State/Province
Umbria
ZIP/Postal Code
06129
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliero Universitaria Di Modena Policlinico
City
Modena
ZIP/Postal Code
41100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone-Piazza Delle Cliniche 2
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione Istituto Neurologico Mondino IRCCS
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Leids Universitair Medisch Centrum
City
Leiden
State/Province
Zuid-Holland
ZIP/Postal Code
2333 ZA
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Akershus Universitetssykehus
City
Nordbyhagen
State/Province
Akershus
ZIP/Postal Code
1474
Country
Norway
Individual Site Status
Recruiting
Facility Name
Haukeland Universitetssykehus
City
Bergen
State/Province
Hordaland
ZIP/Postal Code
5021
Country
Norway
Individual Site Status
Recruiting
Facility Name
St. Olav's University Hospital
City
Trondheim
State/Province
Sør-Trøndelag
ZIP/Postal Code
7006
Country
Norway
Individual Site Status
Recruiting
Facility Name
Oslo Universitetssykehus
City
Oslo
Country
Norway
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Puerta de Hierro - Majadahonda
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital General Universitario Dr. Balmis
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital de La Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Individual Site Status
Completed
Facility Name
Hospital Universitario Vall d'Hebron - PPDS
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Puerta del Mar
City
Cadiz
ZIP/Postal Code
11009
Country
Spain
Individual Site Status
Recruiting
Facility Name
C.H. Regional Reina Sofia - PPDS
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari Arnau de Vilanova
City
Lleida
ZIP/Postal Code
25198
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Fundacion Jimenez Diaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario HM Sanchinarro - CIOCC
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen del Rocio - PPDS
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari i Politecnic La Fe de Valencia
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinico Universitario de Valladolid
City
Valladolid
ZIP/Postal Code
47010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinico Universitario Lozano Blesa
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Skaneuro Privatmottagning
City
Lund
State/Province
Skane Lan
ZIP/Postal Code
222 22
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Karolinska Universitetssjukhuset Huddinge
City
Huddinge
State/Province
Stockholms Lan
ZIP/Postal Code
141 52
Country
Sweden
Individual Site Status
Recruiting
Facility Name
CTC Clinical Trial Consultants AB
City
Solna
State/Province
Stockholms Lan
ZIP/Postal Code
176 64
Country
Sweden
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

A Study of Eptinezumab in Participants With Migraine and Medication Overuse Headache

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