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

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)

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.

Study Overview

• Status: Completed
• Conditions: Episodic Migraine
• Intervention / Treatment: Drug: Placebo; Drug: Atogepant 60 mg

• Study Type: Interventional
• Enrollment (Actual): 315
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Participants received atogepant-matching placebo tablets, orally, once daily (QD) for up to 12 weeks in a double-blind (DB) treatment period.	Drug: Placebo; Atogepant matching placebo tablets.
Active Comparator: Atogepant 60 mg; Participants received atogepant 60 mg, orally, QD for up to 12 weeks in a DB treatment period.	Drug: Atogepant 60 mg; Atogepant tablets.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to Week 12
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.	Baseline to Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to Week 12
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.	Baseline to Week 12
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.	Baseline to Week 12
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.	Baseline to Week 12
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.	Baseline to Week 12
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.	Baseline to Week 12
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.	Baseline to Week 12
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.	Baseline to Week 12
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).	Baseline to Week 12
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).	Baseline to Week 12
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.	Baseline to Week 12
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.	From first dose of study drug until 30 days after last dose of study drug (up to Week 12)

Collaborators and Investigators

• Sponsor: Allergan
• Investigators: Study Director: ALLERGAN INC., Allergan

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2021
• Primary Completion (Actual): August 4, 2022
• Study Completion (Actual): August 4, 2022

Study Registration Dates

• First Submitted: February 2, 2021
• First Submitted That Met QC Criteria: February 2, 2021
• First Posted (Actual): February 5, 2021

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 19, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Episodic migraine
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: 3101-304-002; 2019-003448-58 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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 Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• 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