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Atogepant for Prophylaxis of Migraine in Participants Who Failed Previous Oral Prophylactic Treatments. (ELEVATE)

Primary Purpose

Episodic Migraine

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Atogepant 60 mg
Placebo
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Episodic Migraine focused on measuring Episodic migraine

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • At least a 1-year history of migraine with or without aura consistent with a diagnosis according to the ICHD-3, 2018.
  • Age of the participant at the time of migraine onset < 50 years -History of 4 to 14 migraine days per month on average in the 3 months prior to Visit 1 in the investigator's judgment
  • Female participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period. Male participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period.
  • 4 to 14 migraine days in the 28-day baseline period per eDiary
  • Failed oral migraine prophylaxis medications from 2 to 4 medication classes

Exclusion Criteria:

  • Any clinically significant hematologic, endocrine, pulmonary, hepatic, gastrointestinal, or neurologic disease
  • Participant has any other concurrent pain condition that, in the opinion of the investigator, may significantly impact the current headache disorder
  • In the opinion of the investigator, confounding psychiatric conditions, dementia, epilepsy, or significant neurological disorders other than migraine
  • Has ≥ 15 headache days per month on average across the 3 months prior to Visit 1 in the investigator's judgment
  • Has ≥ 15 headache days in the 28-day baseline period per eDiary
  • Clinically significant cardiovascular or cerebrovascular disease
  • Has a history of migraine accompanied by diplopia or decreased level of consciousness or retinal migraine as defined by ICHD-3, 2018
  • Has a current diagnosis of chronic migraine, new persistent daily headache, medication overuse headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy as defined by ICHD-3, 2018

Sites / Locations

  • Axiom Research /ID# 226379
  • Pharmacology Research Institute (PRI) - Encino (Wake) /ID# 226434
  • Pharmacology Research Institute (PRI) - Los Alamitos (Wake) /ID# 226388
  • Pharmacology Research Institute (PRI) - Los Alamitos (Wake) /ID# 226405
  • Excell Research, Inc /ID# 228386
  • Alpine Clinical Research Center /ID# 226201
  • Sensible Healthcare /ID# 226197
  • Meridien Research /ID# 226224
  • Meridien Research /ID# 226302
  • Velocity Clinical Research - Boise /ID# 226320
  • Allied Physicians - Fort Wayne Neurological Center /ID# 226350
  • Deaconess Clinic - Gateway Health Center /ID# 226481
  • Pharmasite Research, Inc. /ID# 226445
  • StudyMetrix Research /ID# 226297
  • Clinvest Research LLC /ID# 226273
  • Methodist Physicians Clinic /ID# 226470
  • Amici Clinical Research - Raritan /ID# 226282
  • Albuquerque Clinical Trials, Inc /ID# 233445
  • CTI Clinical Trial and Consulting /ID# 226281
  • FutureSearch Trials of Neurology /ID# 226423
  • Austin Clinical Trial Partners /ID# 228387
  • DiscoveResearch, Inc /ID# 226491
  • FutureSearch Trials of Dallas, LP /ID# 226493
  • LinQ Research, LLC /ID# 226227
  • Highland Clinical Research /ID# 226288
  • Northwest Clinical Research Center /ID# 226228
  • Alfred Health /ID# 226341
  • The Royal Melbourne Hospital /ID# 226402
  • Aggarwal and Associates Limited /ID# 226321
  • Ottawa Headache Centre Research Inc /ID# 226257
  • Diex Recherche Sherbrooke Inc. /ID# 226375
  • POLIKLINIKA CHOCEN, a.s. /ID# 226510
  • BRAIN-SOULTHERAPY s.r.o. /ID# 226489
  • CCR Ostrava, s.r.o. /ID# 226279
  • A-SHINE s.r.o. /ID# 226208
  • CLINTRIAL s.r.o. /ID# 226192
  • CCR Czech a.s /ID# 226270
  • FORBELI s.r.o. /ID# 226396
  • DADO MEDICAL s.r.o. /ID# 226548
  • CCR Prague s.r.o. /ID# 226214
  • INEP medical s.r.o. /ID# 226531
  • Vestra Clinics s.r.o. /ID# 226547
  • NeuroMed Zlin s.r.o. /ID# 226487
  • Rigshospitalet Glostrup /ID# 226271
  • CHU Nice - Hopital de Cimiez /ID# 226401
  • CHU de SAINT ETIENNE - Hopital Nord /ID# 226397
  • CHU Lille /ID# 226501
  • CHU Clermont Ferand - Hopital Gabriel Montpied /ID# 226438
  • AP-HP - Hopital Lariboisière /ID# 226221
  • Universitaetsklinikum Tuebingen /ID# 226529
  • Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 226441
  • Klinische Forschung Dresden GmbH /ID# 226194
  • Praxis Dr. Gendolla /ID# 226497
  • Universitaetsklinikum Essen /ID# 226527
  • Klinische Forschung Hannover-Mitte GmbH /ID# 226195
  • Universitaetsklinikum Jena Klinik fuer Neurologie /ID# 226439
  • Vitos Orthopaedische Klinik Kassel gemeinnuetzige GmbH /ID# 231767
  • Schmerzklinik Kiel /ID# 226499
  • AmBeNet GmbH /ID# 226213
  • Pharmakologisches Studienzentrum Chemnitz GmbH /ID# 226202
  • Universitaetsmedizin Rostock /ID# 226517
  • Neuropoint GmbH /ID# 226377
  • Neuropraxis Muenchen Sued /ID# 226216
  • Studienzentrum Nord-West /ID# 226360
  • Intermed GmbH /ID# 226376
  • DKD Helios Klinik Wiesbaden /ID# 226534
  • Bugat Pal Korhaz /ID# 226357
  • Valeomed Kft /ID# 226535
  • Szent Borbala Korhaz /ID# 226400
  • Somogy Megyei Kaposi Mor Oktato Korhaz /ID# 226485
  • Mind Klinika Kft. /ID# 233438
  • Clinexpert Kft /ID# 226467
  • Department of Neurology, University of Szeged /ID# 226442
  • Ospedale Ss. Filippo e Nicola /ID# 226530
  • Fondazione Policlinico Universitario Campus Bio-Medico di Roma /ID# 226361
  • Univ. of Bologna-IRCCS-Istituto delle Scienze Neurologiche /ID# 226475
  • Azienda Ospedaliero Universitaria Careggi /ID# 226502
  • Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 226399
  • AOU Universita degli Studi della Campania Luigi Vanvitelli /ID# 226503
  • Universita di Pavia /ID# 226536
  • Martini Ziekenhuis /ID# 226343
  • Canisius-Wilhelmina Ziekenhuis /ID# 226488
  • ZorgSaam Zorggroep Zeeuws-Vlaanderen /ID# 226317
  • Centrum Medyczne Oporow /ID# 226469
  • NZOZ Vitamed /ID# 226293
  • Gabinet Lekarski Jacek Rozniecki /ID# 226323
  • Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 226235
  • Specjalistyczne Gabinety Sp. z o.o. /ID# 226266
  • Centrum Leczenia Padaczki i Migreny /ID# 226543
  • Duplicate_RCMed Oddzial Sochaczew /ID# 226369
  • Centrum Medyczne Pratia Gdynia /ID# 226437
  • Silmedic Sp. z o.o. /ID# 226267
  • Solumed Centrum Medyczne /ID# 226299
  • EuroMedis sp. z o.o. /ID# 226268
  • Bashkir State Medical University /ID# 226552
  • Kazan State Medical University /ID# 226498
  • Sbhi Cp 2 Hdm /Id# 226494
  • University Headache Clinic /ID# 226435
  • Cephalgolog /ID# 226541
  • Hospital Unversitario Marques de Valdecilla /ID# 226239
  • University Clinical Hospital of Valladolid /ID# 226528
  • Hospital Universitario Vall d'Hebron /ID# 226230
  • Hospital Santa Creu i Sant Pau /ID# 226550
  • Hospital Clinico Universitario San Carlos /ID# 226483
  • Hospital Clinico Universitario de Valencia /ID# 226472
  • Hospital Clinico Universitario Lozano Blesa /ID# 226395
  • Karolinska university hospital, Huddinge /ID# 226215
  • Queen Elizabeth University Hospital /ID# 226492
  • Re:Cognition Health - Guildford /ID# 226539
  • NHS Highland /ID# 226542
  • Leeds Teaching Hospitals NHS Trust /ID# 226538
  • St Pancras Clinical Research /ID# 226551
  • King's College Hospital NHS Foundation Trust /ID# 226525
  • Re:Cognition Health - London /ID# 226540

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Atogepant 60 mg

Arm Description

Participants received atogepant-matching placebo tablets, orally, once daily (QD) for up to 12 weeks in a double-blind (DB) treatment period.

Participants received atogepant 60 mg, orally, QD for up to 12 weeks in a DB treatment period.

Outcomes

Primary Outcome Measures

Change From Baseline in Mean Monthly Migraine Days Across 12-Week Treatment Period in mITT Population
Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache. The monthly (4-week) migraine days were defined as the total number of reported migraine days in diary divided by total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date. Negative change from Baseline indicates improvement. Mixed-effects model for repeated measures (MMRM) was used for analysis.
Change From Baseline in Mean Monthly Migraine Days Across 12-Week Treatment Period in OTHE Population
Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache. The monthly (4-week) migraine days were defined as the total number of reported migraine days in diary divided by total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date. Negative change from Baseline indicates improvement. MMRM was used for analysis.

Secondary Outcome Measures

Number of Participants With At Least a 50% Reduction in 3-Month Average of Monthly Migraine Days Across the 12-week Treatment Period in mITT Population
Data is reported for 50% responders averaged at each 4-week period. 50% responders are participants with at least a 50% reduction from baseline in 3-month average of monthly migraine days. Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache. The monthly (4-week) migraine days are equal to total number of reported migraine days in diary divided by total number of days with diary records in each 4-week period multiplied by 28.
Number of Participants With At Least a 50% Reduction in 3-Month Average of Monthly Migraine Days Across the 12-week Treatment Period in OTHE Population
Data is reported for 50% responders averaged at each 4-week period. 50% responders are participants with at least a 50% reduction from baseline in 3-month average of monthly migraine days. Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache. The monthly (4-week) migraine days are equal to total number of reported migraine days in diary divided by total number of days with diary records in each 4-week period multiplied by 28.
Change From Baseline in Mean Monthly Headache Days Across the 12-week Treatment Period in mITT Population
Participants recorded daily total duration of a headache in a diary. A headache day is any calendar day on which the participant experienced a headache pain lasting 2 hours or longer unless an acute headache medication was used after the start of the headache. The monthly (4-week) headache days were defined as the total number of reported headache days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline is defined as the number of headache days during the last 28 days prior to the randomization date. Negative change from Baseline indicates improvement. MMRM was used for analysis.
Change From Baseline in Mean Monthly Headache Days Across the 12-week Treatment Period in OTHE Population
Participants recorded daily total duration of a headache in a diary. A headache day is any calendar day on which the participant experienced a headache pain lasting 2 hours or longer unless an acute headache medication was used after the start of the headache. The monthly (4-week) headache days were defined as the total number of reported headache days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline is defined as the number of headache days during the last 28 days prior to the randomization date. Negative change from Baseline indicates improvement. MMRM was used for analysis.
Change From Baseline in Mean Monthly Acute Medication Use Days Across the 12-week Treatment Period in mITT Population
An acute medication use day is defined as any day on which a participant reports, per eDiary, the intake of allowed medication(s) to treat an acute migraine. The monthly (4-week) acute medication use days were defined as the total number of reported acute medication use days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date. A negative change from Baseline indicates improvement.
Change From Baseline in Mean Monthly Acute Medication Use Days Across the 12-week Treatment Period in OTHE Population
An acute medication use day is defined as any day on which a participant reports, per eDiary, the intake of allowed medication(s) to treat an acute migraine. The monthly (4-week) acute medication use days were defined as the total number of reported acute medication use days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date. A negative change from Baseline indicates improvement.
Change From Baseline in Migraine Specific Quality of Life Questionnaire (MSQ) v2.1 Role Function-Restrictive Domain Score at Week 12 in mITT Population
The MSQ v2.1 is a 14-item questionnaire designed to measure health-related quality of life impairments attributed to migraine in the past 4 weeks. It is divided into 3 domains: Role Function Restrictive (question numbers 1-7, score ranges 7 to 42) assesses how migraines limit one's daily social and work-related activities; Role Function Preventive (question numbers 8-11, score ranges 4 to 24) assesses how migraines prevent these activities; and the Emotional Function (question numbers 12-14, score ranges 3 to 18) domain assesses the emotions associated with migraines. Participants respond to items using a 6-point scale ranging from none of the time to all of the time. Raw dimension scores are computed as a sum of item responses and rescaled to a 0 to 100 scale, where higher scores indicate better quality of life. MMRM was used for analysis.
Change From Baseline in Migraine Specific Quality of Life Questionnaire (MSQ) v2.1 Role Function-Restrictive Domain Score at Week 12 in OTHE Population
The MSQ v2.1 is a 14-item questionnaire designed to measure health-related quality of life impairments attributed to migraine in the past 4 weeks. It is divided into 3 domains: Role Function Restrictive (question numbers 1-7, score ranges 7 to 42) assesses how migraines limit one's daily social and work-related activities; Role Function Preventive (question numbers 8-11, score ranges 4 to 24) assesses how migraines prevent these activities; and the Emotional Function (question numbers 12-14, score ranges 3 to 18) domain assesses the emotions associated with migraines. Participants respond to items using a 6-point scale ranging from none of the time to all of the time. Raw dimension scores are computed as a sum of item responses and rescaled to a 0 to 100 scale, where higher scores indicate better quality of life. MMRM was used for analysis.
Change From Baseline in Mean Monthly Performance of Daily Activities Domain Score of the Activity Impairment in Migraine - Diary (AIM-D) Across the 12-Week Treatment Period in mITT Population
The AIM-D is a 11-item patient-reported outcome (PRO) measure that assesses the impact of migraine on the performance of daily activities which include, 7 items: difficulty with household chores, errands, leisure activities at home, leisure or social activities outside the home, strenuous physical activities, concentrating, and thinking clearly and physical impairment; 4 items: difficulty walking, moving body, bending forward, moving head using a 6-point rating scale where 0=not difficult at all, 1=a little difficult, 2=somewhat difficult, 3=very difficult, 4=extremely difficult, and 5=I could not do it at all. The raw performance of daily activities domain scores were transformed to 0-100 scale, with higher scores indicating greater impact of migraine (higher disease burden).
Change From Baseline in Mean Monthly Physical Impairment Domain Score of the AIM-D Across the 12-Week Treatment Period in mITT Population
The AIM-D is a 11-item PRO measure that assesses the impact of migraine on the performance of daily activities which includes 7 items: difficulty with household chores, errands, leisure activities at home, leisure or social activities outside the home, strenuous physical activities, concentrating, and thinking clearly and physical impairment; 4 items: difficulty walking, moving body, bending forward, moving head using a 6-point rating scale where 0=not difficult at all, 1=a little difficult, 2=somewhat difficult, 3=very difficult, 4=extremely difficult, and 5=I could not do it at all. The raw physical impairment domain scores were transformed to 0-100 scale, with higher scores indicating greater impact of migraine (higher disease burden).
Change From Baseline in the Headache Impact Test (HIT-6) Total Score at Week 12 in OTHE Population
HIT-6 is a 6-question assessment used to measure the impact headaches have on a participant's ability to function on the job, at school, at home, and in social situations. It assesses the effect that headaches have on normal daily life and the participant's ability to function. Responses are based on frequency using a 5-point scale ranging from "never" to "always." The HIT-6 total score, which ranges from 36 to 78, is the sum of the responses - each of which is assigned a score ranging from 6 points (never) to 13 points (always). MMRM was used for the analyses.
Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. TEAEs were defined as any AE with the onset that was after the first dose of study intervention.

Full Information

First Posted
February 2, 2021
Last Updated
September 19, 2023
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT04740827
Brief Title
Atogepant for Prophylaxis of Migraine in Participants Who Failed Previous Oral Prophylactic Treatments.
Acronym
ELEVATE
Official Title
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Atogepant for the Prophylaxis of Migraine in Participants With Episodic Migraine Who Have Previously Failed 2 to 4 Classes of Oral Prophylactic Treatments (ELEVATE)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
March 5, 2021 (Actual)
Primary Completion Date
August 4, 2022 (Actual)
Study Completion Date
August 4, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will assess the safety, tolerability, and efficacy of Atogepant 60 mg compared with placebo in participants with episodic migraine and who have previously failed 2 to 4 classes of oral prophylactic treatments.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Episodic Migraine
Keywords
Episodic migraine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
315 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received atogepant-matching placebo tablets, orally, once daily (QD) for up to 12 weeks in a double-blind (DB) treatment period.
Arm Title
Atogepant 60 mg
Arm Type
Active Comparator
Arm Description
Participants received atogepant 60 mg, orally, QD for up to 12 weeks in a DB treatment period.
Intervention Type
Drug
Intervention Name(s)
Atogepant 60 mg
Intervention Description
Atogepant tablets.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Atogepant matching placebo tablets.
Primary Outcome Measure Information:
Title
Change From Baseline in Mean Monthly Migraine Days Across 12-Week Treatment Period in mITT Population
Description
Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache. The monthly (4-week) migraine days were defined as the total number of reported migraine days in diary divided by total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date. Negative change from Baseline indicates improvement. Mixed-effects model for repeated measures (MMRM) was used for analysis.
Time Frame
Baseline to Week 12
Title
Change From Baseline in Mean Monthly Migraine Days Across 12-Week Treatment Period in OTHE Population
Description
Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache. The monthly (4-week) migraine days were defined as the total number of reported migraine days in diary divided by total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date. Negative change from Baseline indicates improvement. MMRM was used for analysis.
Time Frame
Baseline to Week 12
Secondary Outcome Measure Information:
Title
Number of Participants With At Least a 50% Reduction in 3-Month Average of Monthly Migraine Days Across the 12-week Treatment Period in mITT Population
Description
Data is reported for 50% responders averaged at each 4-week period. 50% responders are participants with at least a 50% reduction from baseline in 3-month average of monthly migraine days. Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache. The monthly (4-week) migraine days are equal to total number of reported migraine days in diary divided by total number of days with diary records in each 4-week period multiplied by 28.
Time Frame
Baseline to Week 12
Title
Number of Participants With At Least a 50% Reduction in 3-Month Average of Monthly Migraine Days Across the 12-week Treatment Period in OTHE Population
Description
Data is reported for 50% responders averaged at each 4-week period. 50% responders are participants with at least a 50% reduction from baseline in 3-month average of monthly migraine days. Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache. The monthly (4-week) migraine days are equal to total number of reported migraine days in diary divided by total number of days with diary records in each 4-week period multiplied by 28.
Time Frame
Baseline to Week 12
Title
Change From Baseline in Mean Monthly Headache Days Across the 12-week Treatment Period in mITT Population
Description
Participants recorded daily total duration of a headache in a diary. A headache day is any calendar day on which the participant experienced a headache pain lasting 2 hours or longer unless an acute headache medication was used after the start of the headache. The monthly (4-week) headache days were defined as the total number of reported headache days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline is defined as the number of headache days during the last 28 days prior to the randomization date. Negative change from Baseline indicates improvement. MMRM was used for analysis.
Time Frame
Baseline to Week 12
Title
Change From Baseline in Mean Monthly Headache Days Across the 12-week Treatment Period in OTHE Population
Description
Participants recorded daily total duration of a headache in a diary. A headache day is any calendar day on which the participant experienced a headache pain lasting 2 hours or longer unless an acute headache medication was used after the start of the headache. The monthly (4-week) headache days were defined as the total number of reported headache days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline is defined as the number of headache days during the last 28 days prior to the randomization date. Negative change from Baseline indicates improvement. MMRM was used for analysis.
Time Frame
Baseline to Week 12
Title
Change From Baseline in Mean Monthly Acute Medication Use Days Across the 12-week Treatment Period in mITT Population
Description
An acute medication use day is defined as any day on which a participant reports, per eDiary, the intake of allowed medication(s) to treat an acute migraine. The monthly (4-week) acute medication use days were defined as the total number of reported acute medication use days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date. A negative change from Baseline indicates improvement.
Time Frame
Baseline to Week 12
Title
Change From Baseline in Mean Monthly Acute Medication Use Days Across the 12-week Treatment Period in OTHE Population
Description
An acute medication use day is defined as any day on which a participant reports, per eDiary, the intake of allowed medication(s) to treat an acute migraine. The monthly (4-week) acute medication use days were defined as the total number of reported acute medication use days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date. A negative change from Baseline indicates improvement.
Time Frame
Baseline to Week 12
Title
Change From Baseline in Migraine Specific Quality of Life Questionnaire (MSQ) v2.1 Role Function-Restrictive Domain Score at Week 12 in mITT Population
Description
The MSQ v2.1 is a 14-item questionnaire designed to measure health-related quality of life impairments attributed to migraine in the past 4 weeks. It is divided into 3 domains: Role Function Restrictive (question numbers 1-7, score ranges 7 to 42) assesses how migraines limit one's daily social and work-related activities; Role Function Preventive (question numbers 8-11, score ranges 4 to 24) assesses how migraines prevent these activities; and the Emotional Function (question numbers 12-14, score ranges 3 to 18) domain assesses the emotions associated with migraines. Participants respond to items using a 6-point scale ranging from none of the time to all of the time. Raw dimension scores are computed as a sum of item responses and rescaled to a 0 to 100 scale, where higher scores indicate better quality of life. MMRM was used for analysis.
Time Frame
Baseline to Week 12
Title
Change From Baseline in Migraine Specific Quality of Life Questionnaire (MSQ) v2.1 Role Function-Restrictive Domain Score at Week 12 in OTHE Population
Description
The MSQ v2.1 is a 14-item questionnaire designed to measure health-related quality of life impairments attributed to migraine in the past 4 weeks. It is divided into 3 domains: Role Function Restrictive (question numbers 1-7, score ranges 7 to 42) assesses how migraines limit one's daily social and work-related activities; Role Function Preventive (question numbers 8-11, score ranges 4 to 24) assesses how migraines prevent these activities; and the Emotional Function (question numbers 12-14, score ranges 3 to 18) domain assesses the emotions associated with migraines. Participants respond to items using a 6-point scale ranging from none of the time to all of the time. Raw dimension scores are computed as a sum of item responses and rescaled to a 0 to 100 scale, where higher scores indicate better quality of life. MMRM was used for analysis.
Time Frame
Baseline to Week 12
Title
Change From Baseline in Mean Monthly Performance of Daily Activities Domain Score of the Activity Impairment in Migraine - Diary (AIM-D) Across the 12-Week Treatment Period in mITT Population
Description
The AIM-D is a 11-item patient-reported outcome (PRO) measure that assesses the impact of migraine on the performance of daily activities which include, 7 items: difficulty with household chores, errands, leisure activities at home, leisure or social activities outside the home, strenuous physical activities, concentrating, and thinking clearly and physical impairment; 4 items: difficulty walking, moving body, bending forward, moving head using a 6-point rating scale where 0=not difficult at all, 1=a little difficult, 2=somewhat difficult, 3=very difficult, 4=extremely difficult, and 5=I could not do it at all. The raw performance of daily activities domain scores were transformed to 0-100 scale, with higher scores indicating greater impact of migraine (higher disease burden).
Time Frame
Baseline to Week 12
Title
Change From Baseline in Mean Monthly Physical Impairment Domain Score of the AIM-D Across the 12-Week Treatment Period in mITT Population
Description
The AIM-D is a 11-item PRO measure that assesses the impact of migraine on the performance of daily activities which includes 7 items: difficulty with household chores, errands, leisure activities at home, leisure or social activities outside the home, strenuous physical activities, concentrating, and thinking clearly and physical impairment; 4 items: difficulty walking, moving body, bending forward, moving head using a 6-point rating scale where 0=not difficult at all, 1=a little difficult, 2=somewhat difficult, 3=very difficult, 4=extremely difficult, and 5=I could not do it at all. The raw physical impairment domain scores were transformed to 0-100 scale, with higher scores indicating greater impact of migraine (higher disease burden).
Time Frame
Baseline to Week 12
Title
Change From Baseline in the Headache Impact Test (HIT-6) Total Score at Week 12 in OTHE Population
Description
HIT-6 is a 6-question assessment used to measure the impact headaches have on a participant's ability to function on the job, at school, at home, and in social situations. It assesses the effect that headaches have on normal daily life and the participant's ability to function. Responses are based on frequency using a 5-point scale ranging from "never" to "always." The HIT-6 total score, which ranges from 36 to 78, is the sum of the responses - each of which is assigned a score ranging from 6 points (never) to 13 points (always). MMRM was used for the analyses.
Time Frame
Baseline to Week 12
Title
Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
Description
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. TEAEs were defined as any AE with the onset that was after the first dose of study intervention.
Time Frame
From first dose of study drug until 30 days after last dose of study drug (up to Week 12)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At least a 1-year history of migraine with or without aura consistent with a diagnosis according to the ICHD-3, 2018. Age of the participant at the time of migraine onset < 50 years -History of 4 to 14 migraine days per month on average in the 3 months prior to Visit 1 in the investigator's judgment Female participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period. Male participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period. 4 to 14 migraine days in the 28-day baseline period per eDiary Failed oral migraine prophylaxis medications from 2 to 4 medication classes Exclusion Criteria: Any clinically significant hematologic, endocrine, pulmonary, hepatic, gastrointestinal, or neurologic disease Participant has any other concurrent pain condition that, in the opinion of the investigator, may significantly impact the current headache disorder In the opinion of the investigator, confounding psychiatric conditions, dementia, epilepsy, or significant neurological disorders other than migraine Has ≥ 15 headache days per month on average across the 3 months prior to Visit 1 in the investigator's judgment Has ≥ 15 headache days in the 28-day baseline period per eDiary Clinically significant cardiovascular or cerebrovascular disease Has a history of migraine accompanied by diplopia or decreased level of consciousness or retinal migraine as defined by ICHD-3, 2018 Has a current diagnosis of chronic migraine, new persistent daily headache, medication overuse headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy as defined by ICHD-3, 2018
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ALLERGAN INC.
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Axiom Research /ID# 226379
City
Colton
State/Province
California
ZIP/Postal Code
92324
Country
United States
Facility Name
Pharmacology Research Institute (PRI) - Encino (Wake) /ID# 226434
City
Encino
State/Province
California
ZIP/Postal Code
91316
Country
United States
Facility Name
Pharmacology Research Institute (PRI) - Los Alamitos (Wake) /ID# 226388
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720-3500
Country
United States
Facility Name
Pharmacology Research Institute (PRI) - Los Alamitos (Wake) /ID# 226405
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720-3500
Country
United States
Facility Name
Excell Research, Inc /ID# 228386
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Alpine Clinical Research Center /ID# 226201
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80301-1880
Country
United States
Facility Name
Sensible Healthcare /ID# 226197
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Facility Name
Meridien Research /ID# 226224
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
Meridien Research /ID# 226302
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
Velocity Clinical Research - Boise /ID# 226320
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Allied Physicians - Fort Wayne Neurological Center /ID# 226350
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Facility Name
Deaconess Clinic - Gateway Health Center /ID# 226481
City
Newburgh
State/Province
Indiana
ZIP/Postal Code
47630
Country
United States
Facility Name
Pharmasite Research, Inc. /ID# 226445
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21208
Country
United States
Facility Name
StudyMetrix Research /ID# 226297
City
Saint Peters
State/Province
Missouri
ZIP/Postal Code
63303
Country
United States
Facility Name
Clinvest Research LLC /ID# 226273
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Methodist Physicians Clinic /ID# 226470
City
Fremont
State/Province
Nebraska
ZIP/Postal Code
68025
Country
United States
Facility Name
Amici Clinical Research - Raritan /ID# 226282
City
Raritan
State/Province
New Jersey
ZIP/Postal Code
08869
Country
United States
Facility Name
Albuquerque Clinical Trials, Inc /ID# 233445
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
CTI Clinical Trial and Consulting /ID# 226281
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
FutureSearch Trials of Neurology /ID# 226423
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Austin Clinical Trial Partners /ID# 228387
City
Austin
State/Province
Texas
ZIP/Postal Code
78737
Country
United States
Facility Name
DiscoveResearch, Inc /ID# 226491
City
Bryan
State/Province
Texas
ZIP/Postal Code
77802
Country
United States
Facility Name
FutureSearch Trials of Dallas, LP /ID# 226493
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
LinQ Research, LLC /ID# 226227
City
Pearland
State/Province
Texas
ZIP/Postal Code
77584
Country
United States
Facility Name
Highland Clinical Research /ID# 226288
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
Northwest Clinical Research Center /ID# 226228
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
Alfred Health /ID# 226341
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
The Royal Melbourne Hospital /ID# 226402
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Aggarwal and Associates Limited /ID# 226321
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6T 0G1
Country
Canada
Facility Name
Ottawa Headache Centre Research Inc /ID# 226257
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K2G 6E2
Country
Canada
Facility Name
Diex Recherche Sherbrooke Inc. /ID# 226375
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1L 0H8
Country
Canada
Facility Name
POLIKLINIKA CHOCEN, a.s. /ID# 226510
City
Chocen
ZIP/Postal Code
565 01
Country
Czechia
Facility Name
BRAIN-SOULTHERAPY s.r.o. /ID# 226489
City
Kladno
ZIP/Postal Code
272 01
Country
Czechia
Facility Name
CCR Ostrava, s.r.o. /ID# 226279
City
Ostrava
ZIP/Postal Code
702 00
Country
Czechia
Facility Name
A-SHINE s.r.o. /ID# 226208
City
Plzen
ZIP/Postal Code
301 00
Country
Czechia
Facility Name
CLINTRIAL s.r.o. /ID# 226192
City
Prague 10
ZIP/Postal Code
100 00
Country
Czechia
Facility Name
CCR Czech a.s /ID# 226270
City
Prague 4
ZIP/Postal Code
140 00
Country
Czechia
Facility Name
FORBELI s.r.o. /ID# 226396
City
Prague
ZIP/Postal Code
160 00
Country
Czechia
Facility Name
DADO MEDICAL s.r.o. /ID# 226548
City
Praha
ZIP/Postal Code
120 00
Country
Czechia
Facility Name
CCR Prague s.r.o. /ID# 226214
City
Praha
ZIP/Postal Code
130 00
Country
Czechia
Facility Name
INEP medical s.r.o. /ID# 226531
City
Praha
ZIP/Postal Code
186 00
Country
Czechia
Facility Name
Vestra Clinics s.r.o. /ID# 226547
City
Rychnov nad Kneznou
ZIP/Postal Code
516 01
Country
Czechia
Facility Name
NeuroMed Zlin s.r.o. /ID# 226487
City
Zlin
ZIP/Postal Code
760 01
Country
Czechia
Facility Name
Rigshospitalet Glostrup /ID# 226271
City
Glostrup
State/Province
Hovedstaden
ZIP/Postal Code
2600
Country
Denmark
Facility Name
CHU Nice - Hopital de Cimiez /ID# 226401
City
Nice
State/Province
Alpes-Maritimes
ZIP/Postal Code
06000
Country
France
Facility Name
CHU de SAINT ETIENNE - Hopital Nord /ID# 226397
City
St. Priest En Jarez
State/Province
Loire
ZIP/Postal Code
42270
Country
France
Facility Name
CHU Lille /ID# 226501
City
Lille
State/Province
Nord
ZIP/Postal Code
59000
Country
France
Facility Name
CHU Clermont Ferand - Hopital Gabriel Montpied /ID# 226438
City
Clermont Ferrand
ZIP/Postal Code
63000
Country
France
Facility Name
AP-HP - Hopital Lariboisière /ID# 226221
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Universitaetsklinikum Tuebingen /ID# 226529
City
Tubingen
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
72076
Country
Germany
Facility Name
Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 226441
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Klinische Forschung Dresden GmbH /ID# 226194
City
Dresden
ZIP/Postal Code
01069
Country
Germany
Facility Name
Praxis Dr. Gendolla /ID# 226497
City
Essen
ZIP/Postal Code
45133
Country
Germany
Facility Name
Universitaetsklinikum Essen /ID# 226527
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Klinische Forschung Hannover-Mitte GmbH /ID# 226195
City
Hannover
ZIP/Postal Code
30159
Country
Germany
Facility Name
Universitaetsklinikum Jena Klinik fuer Neurologie /ID# 226439
City
Jena
ZIP/Postal Code
07747
Country
Germany
Facility Name
Vitos Orthopaedische Klinik Kassel gemeinnuetzige GmbH /ID# 231767
City
Kassel
ZIP/Postal Code
34131
Country
Germany
Facility Name
Schmerzklinik Kiel /ID# 226499
City
Kiel
ZIP/Postal Code
24149
Country
Germany
Facility Name
AmBeNet GmbH /ID# 226213
City
Leipzig
ZIP/Postal Code
04107
Country
Germany
Facility Name
Pharmakologisches Studienzentrum Chemnitz GmbH /ID# 226202
City
Mittweida
ZIP/Postal Code
09648
Country
Germany
Facility Name
Universitaetsmedizin Rostock /ID# 226517
City
Rostock
ZIP/Postal Code
18057
Country
Germany
Facility Name
Neuropoint GmbH /ID# 226377
City
Ulm
ZIP/Postal Code
89073
Country
Germany
Facility Name
Neuropraxis Muenchen Sued /ID# 226216
City
Unterhaching
ZIP/Postal Code
82008
Country
Germany
Facility Name
Studienzentrum Nord-West /ID# 226360
City
Westerstede
ZIP/Postal Code
26655
Country
Germany
Facility Name
Intermed GmbH /ID# 226376
City
Wiesbaden
ZIP/Postal Code
65189
Country
Germany
Facility Name
DKD Helios Klinik Wiesbaden /ID# 226534
City
Wiesbaden
ZIP/Postal Code
65191
Country
Germany
Facility Name
Bugat Pal Korhaz /ID# 226357
City
Gyöngyös
State/Province
Heves
ZIP/Postal Code
3200
Country
Hungary
Facility Name
Valeomed Kft /ID# 226535
City
Esztergom
State/Province
Komarom-Esztergom
ZIP/Postal Code
2500
Country
Hungary
Facility Name
Szent Borbala Korhaz /ID# 226400
City
Tatabanya
State/Province
Komarom-Esztergom
ZIP/Postal Code
2800
Country
Hungary
Facility Name
Somogy Megyei Kaposi Mor Oktato Korhaz /ID# 226485
City
Kaposvár
State/Province
Somogy
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Mind Klinika Kft. /ID# 233438
City
Budapest
ZIP/Postal Code
1024
Country
Hungary
Facility Name
Clinexpert Kft /ID# 226467
City
Budapest
ZIP/Postal Code
1033
Country
Hungary
Facility Name
Department of Neurology, University of Szeged /ID# 226442
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Facility Name
Ospedale Ss. Filippo e Nicola /ID# 226530
City
Avezzano
State/Province
L Aquila
ZIP/Postal Code
67051
Country
Italy
Facility Name
Fondazione Policlinico Universitario Campus Bio-Medico di Roma /ID# 226361
City
Rome
State/Province
Lazio
ZIP/Postal Code
00128
Country
Italy
Facility Name
Univ. of Bologna-IRCCS-Istituto delle Scienze Neurologiche /ID# 226475
City
Bologna
ZIP/Postal Code
40126
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Careggi /ID# 226502
City
Florence
ZIP/Postal Code
50134
Country
Italy
Facility Name
Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 226399
City
Milan
ZIP/Postal Code
20133
Country
Italy
Facility Name
AOU Universita degli Studi della Campania Luigi Vanvitelli /ID# 226503
City
Napoli
ZIP/Postal Code
80138
Country
Italy
Facility Name
Universita di Pavia /ID# 226536
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Martini Ziekenhuis /ID# 226343
City
Groningen
ZIP/Postal Code
9728 NT
Country
Netherlands
Facility Name
Canisius-Wilhelmina Ziekenhuis /ID# 226488
City
Nijmegen
ZIP/Postal Code
6532 SZ
Country
Netherlands
Facility Name
ZorgSaam Zorggroep Zeeuws-Vlaanderen /ID# 226317
City
Terneuzen
ZIP/Postal Code
4535 PA
Country
Netherlands
Facility Name
Centrum Medyczne Oporow /ID# 226469
City
Wroclaw
State/Province
Dolnoslaskie
ZIP/Postal Code
52-416
Country
Poland
Facility Name
NZOZ Vitamed /ID# 226293
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
85-079
Country
Poland
Facility Name
Gabinet Lekarski Jacek Rozniecki /ID# 226323
City
Lodz
State/Province
Lodzkie
ZIP/Postal Code
90-338
Country
Poland
Facility Name
Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 226235
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-582
Country
Poland
Facility Name
Specjalistyczne Gabinety Sp. z o.o. /ID# 226266
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
30-539
Country
Poland
Facility Name
Centrum Leczenia Padaczki i Migreny /ID# 226543
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
31-209
Country
Poland
Facility Name
Duplicate_RCMed Oddzial Sochaczew /ID# 226369
City
Sochaczew
State/Province
Mazowieckie
ZIP/Postal Code
96-500
Country
Poland
Facility Name
Centrum Medyczne Pratia Gdynia /ID# 226437
City
Gdynia
State/Province
Pomorskie
ZIP/Postal Code
81-338
Country
Poland
Facility Name
Silmedic Sp. z o.o. /ID# 226267
City
Katowice
State/Province
Slaskie
ZIP/Postal Code
40-282
Country
Poland
Facility Name
Solumed Centrum Medyczne /ID# 226299
City
Poznan
State/Province
Wielkopolskie
ZIP/Postal Code
60-529
Country
Poland
Facility Name
EuroMedis sp. z o.o. /ID# 226268
City
Szczecin
State/Province
Zachodniopomorskie
ZIP/Postal Code
70-111
Country
Poland
Facility Name
Bashkir State Medical University /ID# 226552
City
Ufa
State/Province
Bashkortostan, Respublika
ZIP/Postal Code
450005
Country
Russian Federation
Facility Name
Kazan State Medical University /ID# 226498
City
Kazan
State/Province
Tatarstan, Respublika
ZIP/Postal Code
420012
Country
Russian Federation
Facility Name
Sbhi Cp 2 Hdm /Id# 226494
City
Moscow
ZIP/Postal Code
117556
Country
Russian Federation
Facility Name
University Headache Clinic /ID# 226435
City
Moscow
ZIP/Postal Code
119221
Country
Russian Federation
Facility Name
Cephalgolog /ID# 226541
City
Moscow
ZIP/Postal Code
125040
Country
Russian Federation
Facility Name
Hospital Unversitario Marques de Valdecilla /ID# 226239
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Facility Name
University Clinical Hospital of Valladolid /ID# 226528
City
Valledolid
State/Province
Castellon
ZIP/Postal Code
47005
Country
Spain
Facility Name
Hospital Universitario Vall d'Hebron /ID# 226230
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Santa Creu i Sant Pau /ID# 226550
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Hospital Clinico Universitario San Carlos /ID# 226483
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Clinico Universitario de Valencia /ID# 226472
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Hospital Clinico Universitario Lozano Blesa /ID# 226395
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Karolinska university hospital, Huddinge /ID# 226215
City
Huddinge
State/Province
Stockholms Lan
ZIP/Postal Code
141 86
Country
Sweden
Facility Name
Queen Elizabeth University Hospital /ID# 226492
City
Glasgow
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Facility Name
Re:Cognition Health - Guildford /ID# 226539
City
Guildford
ZIP/Postal Code
GU2 7YD
Country
United Kingdom
Facility Name
NHS Highland /ID# 226542
City
Inverness
ZIP/Postal Code
IV2 3UJ
Country
United Kingdom
Facility Name
Leeds Teaching Hospitals NHS Trust /ID# 226538
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
St Pancras Clinical Research /ID# 226551
City
London
ZIP/Postal Code
EC2Y 8EA
Country
United Kingdom
Facility Name
King's College Hospital NHS Foundation Trust /ID# 226525
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Re:Cognition Health - London /ID# 226540
City
London
ZIP/Postal Code
W1G 9JF
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/

Learn more about this trial

Atogepant for Prophylaxis of Migraine in Participants Who Failed Previous Oral Prophylactic Treatments.

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