AzTrials
AzTrials

Chronic MigrainePhase 3NCT03855137

Efficacy, Safety, and Tolerability of Atogepant for the Prevention of Chronic Migraine

A Phase 3 study testing Atogepant 30 mg and Atogepant 60 mg in people with Chronic Migraine, run by Allergan at 150 sites in 17 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study evaluated the efficacy, safety and tolerability of atogepant in participants with chronic migraine. This study included a 12-week treatment period. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Chronic Migraine
What is being tested?
Atogepant 30 mg and Atogepant 60 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
778 participants
Where
150 sitesin 17 countries
Study dates
11 Mar 2019to 20 Jan 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • At least a 1-year history of chronic migraine (CM) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3), 2018
  • Age of the participant at the time of migraine onset < 50 years
  • Confirmation of headache/migraine headache day frequency as follows:
  • History of, on average, ≥ 15 headache days per month in the 3 months prior to Visit 1 in the opinion of the investigator AND
  • >=15 headache days during the 4-week screening/baseline period per the electronic diary (eDiary) AND
  • >=8 days during the 4-week screening/baseline period that qualify as being a migraine day per the eDiary
  • Participants must be using a medically acceptable and effective method of birth control during the course of the entire study

Who cannot join

  • Has a history of migraine, accompanied by diplopia or decreased level of consciousness, or retinal migraine
  • Has a current diagnosis of new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy
  • History of an inadequate response to > 4 medications (2 of which have different mechanisms of action) prescribed for the prevention of migraine
  • Woman is pregnant, planning to become pregnant during the course of the study, or currently lactating. Women of childbearing potential must have a negative urine pregnancy test at Visit 1 and Visit 2.

Trial locations and contacts

150 sites in 17 countries.

150 sites in 17 countries

United States41 sites

  • Abington Neurological Associates - Abington /ID# 236258

    Abington, Pennsylvania, 19001

  • Albany Medical Center Rheumatology /ID# 236540

    Albany, New York, 12208-3412

  • Albuquerque Clinical Trials, Inc /ID# 236853

    Albuquerque, New Mexico, 87102

  • Dent Neurosciences Research Center, Inc. /ID# 237040

    Amherst, New York, 14226

  • NeuroTrials Research Inc. /ID# 237364

    Atlanta, Georgia, 30328

  • Northwest Clinical Research Center /ID# 237581

    Bellevue, Washington, 98007

  • Beth Israel Deaconess Medical Center /ID# 237540

    Boston, Massachusetts, 02215-5400

  • Alpine Clinical Research Center /ID# 234346

    Boulder, Colorado, 80301-1880

  • DiscoveResearch, Inc /ID# 236274

    Bryan, Texas, 77802

  • WR-ClinSearch /ID# 238288

    Chattanooga, Tennessee, 37421-1605

  • Stetson-University of Cincinnati /ID# 236453

    Cincinnati, Ohio, 45219

  • Ochsner Clinic Foundation /ID# 236543

    Covington, Louisiana, 70433-8107

  • Texas Neurology /ID# 236359

    Dallas, Texas, 75214

  • University of Texas Southwestern Medical Center /ID# 236941

    Dallas, Texas, 75390-7208

  • California Headache and Balance Center /ID# 236246

    Fresno, California, 93720

  • Headache Wellness Center /ID# 236431

    Greensboro, North Carolina, 27405

  • Josephson-Wallack-Munshower Neurology - NE /ID# 238234

    Indianapolis, Indiana, 46256-4692

  • Nevada Headache Institute /ID# 236420

    Las Vegas, Nevada, 89113

  • Dartmouth-Hitchcock Medical Center /ID# 237444

    Lebanon, New Hampshire, 03756

  • Baptist Health Center for Clinical Research /ID# 237361

    Little Rock, Arkansas, 72205

  • Wr-Pri Llc /Id# 236008

    Los Alamitos, California, 90720

  • MedStar Georgetown Neurology /ID# 236324

    McLean, Virginia, 22101

  • Clinical Neuroscience Solutions - Memphis /ID# 237478

    Memphis, Tennessee, 38119

  • Clinical Research Institute, Inc /ID# 238299

    Minneapolis, Minnesota, 55402-2606

  • BTC of New Bedford /ID# 236384

    New Bedford, Massachusetts, 02740

  • Pharmacology Research Institute (PRI) - Newport Beach (Wake) /ID# 237692

    Newport Beach, California, 92660

  • Barrow Neuro Institute /ID# 236776

    Phoenix, Arizona, 85013

  • Preferred Primary Care Physicians, Inc. /ID# 236439

    Pittsburgh, Pennsylvania, 15236

  • Collective Medical Research /ID# 236400

    Prairie Village, Kansas, 66208

  • Raleigh Neurology Associates /ID# 237141

    Raleigh, North Carolina, 27607

  • Headache Neurology Research Institute /ID# 236464

    Ridgeland, Mississippi, 39157

  • J. Lewis Research, Inc. / Foothill Family Clinic /ID# 236395

    Salt Lake City, Utah, 84109

  • J. Lewis Research, Inc. Foothill Family Clinic South /ID# 236297

    Salt Lake City, Utah, 84121

  • Highland Clinical Research /ID# 237816

    Salt Lake City, Utah, 84124

  • Schuster Medical Research Institute /ID# 236447

    Sherman Oaks, California, 91403

  • Accel Research Sites - St Petersburg Clinical Research Unit /ID# 237161

    St. Petersburg, Florida, 33709-3113

  • Puget Sound Neurology /ID# 236321

    Tacoma, Washington, 25328

  • Accel Research Sites - Tampa Clinical Research Unit /ID# 237485

    Tampa, Florida, 33634

  • Sentara Neurology Specialists - Virginia Beach /ID# 234349

    Virginia Beach, Virginia, 23456-0019

  • George Washington University Medical Faculty Associates /ID# 238011

    Washington D.C., District of Columbia, 20037-3201

  • Premiere Research Institute - Palm Beach /ID# 238192

    West Palm Beach, Florida, 33407-3209

Other trials in United States

Japan23 sites

  • Niwa Family Clinic /ID# 234552

    Chofu-shi, Tokyo, 182-0006

  • Fukuiken Saiseikai Hospital /ID# 236794

    Fukui-shi, Fukui, 918-8235

  • DOI Internal Medicine-Neurology Clinic /ID# 234562

    Hiroshima, 730-0031

  • Hiroshima Neurology Clinic /ID# 234563

    Hiroshima, 732-0822

  • Saitama Medical University Hospital /ID# 237019

    Iruma-gun, Saitama, 350-0495

  • Tokai University Hospital /ID# 237595

    Isehara-shi, Kanagawa, 259-1193

  • Atsuchi Neurosurgical Hospital /ID# 234779

    Kagoshima, Kagoshima-ken, 892-0842

  • Tanaka Neurosurgical clinic /ID# 234760

    Kagoshima, 892-0844

  • Nagaseki Headache Clinic /ID# 234561

    Kai-shi, Yamanashi, 400-0124

  • Fujitsu Clinic /ID# 237443

    Kawasaki-shi, Kanagawa, 211-8588

  • Konan Medical Center /ID# 236230

    Kobe, Hyōgo, 658-0064

  • Umenotsuji Clinic /ID# 234495

    Kochi, Kochi, 780-8011

  • Tatsuoka Neurology Clinic /ID# 234782

    Kyoto, 600-8811

  • Takanoko Hospital /ID# 234564

    Matsuyama, Ehime, 790-0925

  • Tominaga Hospital /ID# 234781

    Osaka, 556-0017

  • Saitama Neuropsychiatric Institute /Id# 234550

    Saitama-shi, Saitama, 338-8577

  • Higashi Sapporo Neurology and Neurosurgery Clinic /ID# 234549

    Sapporo, Hokkaido, 003-0003

  • Sendai Headache and Neurology Clinic Medical Corporation /ID# 234496

    Sendai, Miyagi, 982-0014

  • Tokyo Headache Clinic /ID# 234555

    Shibuya-ku, Tokyo, 151-0051

  • Dokkyo Medical University Hospital /ID# 236810

    Shimotsuga-gun, Tochigi, 321-0293

  • Keio University Hospital /ID# 237210

    Shinjuku-ku, Tokyo, 160-8582

  • Japanese Red Cross Shizuoka Hospital /ID# 234372

    Shizuoka, Shizuoka, 420-0853

  • Shinagawa Strings Clinic /ID# 234780

    Tokyo, 108-0075

Other trials in Japan

China16 sites

  • Peking University Third Hospital /ID# 238150

    Beijing, Beijing Municipality, 100191

  • Chinese PLA General Hospital /ID# 238237

    Beijing, Beijing Municipality, 100853

  • Beijing Friendship Hospital /ID# 237264

    Beijing, 100032

  • The Second Hospital of Jilin University /ID# 236520

    Changchun, Jilin, 130022

  • Guangzhou First People's Hospital /ID# 236510

    Guangzhou, Guangdong, 510180

  • The Second Affiliated Hospital of Guangzhou Medical University /ID# 238133

    Guangzhou, Guangdong, 510260

  • The second Affiliated hospital of Zhejiang University school of Medicine /ID# 238260

    Hangzhou, Zhejiang, 310009

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine /ID# 236500

    Hangzhou, Zhejiang, 310020

  • Jiangsu Province Hospital /ID# 237846

    Nanjing, Jiangsu, 210029

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 237847

    Shanghai, Shanghai Municipality, 200065

  • The Second Hospital of Soochow University /ID# 234296

    Suzhou, 215004

  • The Second Hospital of Shanxi Medical University /ID# 236529

    Taiyuan, Shanxi, 030000

  • Tianjin Huanhu Hospital (THH) /ID# 236524

    Tianjin, 300350

  • Hubei General Hospital /ID# 236486

    Wuhan, Hebei, 430060

  • Tongji Hospital Tongji Medical College of HUST /ID# 237835

    Wuhan, 430030

  • The First Affiliated Hospital of Zhengzhou University /ID# 237025

    Zhengzhou, Henan, 450052

Other trials in China

Czechia9 sites

  • NEUROHK s.r.o. /ID# 236290

    Hradec Králové, 500 09

  • BRAIN-SOULTHERAPY s.r.o. /ID# 236380

    Kladno, 272 01

  • CCR Ostrava, s.r.o. /ID# 234291

    Ostrava, 702 00

  • CLINTRIAL s.r.o. /ID# 237793

    Prague, 100 00

  • CCR Prague s.r.o. /ID# 236250

    Prague, 130 00

  • CCR Czech a.s /ID# 236249

    Prague, 140 00

  • Thomayerova nemocnice /ID# 237175

    Prague, 140 59

  • FORBELI s.r.o. /ID# 236427

    Prague, 160 00

  • NeuroMed Zlin s.r.o. /ID# 236416

    Zlín, 760 01

Other trials in Czechia

Poland8 sites

  • NZOZ Vitamed /ID# 237041

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-079

  • Centrum Medyczne Pratia Gdynia /ID# 237077

    Gdynia, Pomeranian Voivodeship, 81-338

  • Silmedic Sp. z o.o. /ID# 237343

    Katowice, Silesian Voivodeship, 40-282

  • Specjalistyczne Gabinety Sp. z o.o. /ID# 236348

    Krakow, Lesser Poland Voivodeship, 30-539

  • Centrum Leczenia Padaczki i Migreny /ID# 236386

    Krakow, Lesser Poland Voivodeship, 31-209

  • Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 236289

    Lublin, Lublin Voivodeship, 20-582

  • Solumed Centrum Medyczne /ID# 236452

    Poznan, Greater Poland Voivodeship, 60-529

  • EuroMedis sp. z o.o. /ID# 236417

    Szczecin, West Pomeranian Voivodeship, 70-111

Other trials in Poland

Spain8 sites

  • Hospital Universitario Vall d'Hebron /ID# 236467

    Barcelona, 08035

  • CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 237645

    Pamplona, Navarre, 31008

  • Hospital Clínico Universitario de Santiago-CHUS /ID# 237623

    Santiago de Compostela, A Coruna, 15706

  • Hospital Universitario Virgen del Rocio /ID# 237106

    Seville, 41013

  • Hospital Clinico Universitario de Valencia /ID# 237400

    Valencia, 46010

  • Hospital Universitario y Politecnico La Fe /ID# 237087

    Valencia, 46026

  • Hospital Clinico Universitario de Valladolid /ID# 234406

    Valladolid, 47003

  • Hospital Clinico Universitario Lozano Blesa /ID# 237373

    Zaragoza, 50009

Other trials in Spain

Germany7 sites

  • Charite Universitaetsklinikum Berlin - Campus Virchow /ID# 237256

    Berlin, 13353

  • Praxis Dr. Gendolla /ID# 236311

    Essen, 45133

  • Universitaetsklinikum Essen /ID# 237209

    Essen, 45147

  • CTC North GmbH & Co. KG /ID# 236328

    Hamburg, 20251

  • Vitos Orthopaedische Klinik Kassel gemeinnuetzige GmbH /ID# 236723

    Kassel, 34131

  • Schmerzklinik Kiel /ID# 236444

    Kiel, 24149

  • LMU Klinikum Campus Grosshadern /ID# 236293

    München, 81377

Other trials in Germany

South Korea7 sites

  • Pusan National University Hospital /ID# 237120

    Busan, 49241

  • Dongtan Sacred Heart Hospital /ID# 238097

    Hwaseong, Gyeonggido, 18450

  • Kangbuk Samsung Hospital /ID# 237754

    Seoul, Seoul Teugbyeolsi, 03181

  • Yonsei University Health System Severance Hospital /ID# 237839

    Seoul, Seoul Teugbyeolsi, 03722

  • Nowon Eulji Medical Center, Eulji University /ID# 236306

    Seoul, 01830

  • Seoul National University Hospital /ID# 237786

    Seoul, 03080

  • Samsung Medical Center /ID# 237785

    Seoul, 06351

Other trials in South Korea

Italy6 sites

  • Azienda Ospedaliera Universitaria Consorziale Policlinico /ID# 237492

    Bari, 70124

  • Azienda Ospedaliero Universitaria Careggi /ID# 237598

    Florence, 50134

  • Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 237291

    Milan, 20133

  • AOU Universita degli Studi della Campania Luigi Vanvitelli /ID# 236361

    Naples, 80138

  • Universita di Pavia /ID# 236363

    Pavia, 27100

  • IRCCS San Raffaele Pisana /ID# 236552

    Rome, 00163

Other trials in Italy

Canada5 sites

  • CHAMP Clinic /ID# 236252

    Calgary, Alberta, T3M 1M4

  • Clinique des cephalees de Montreal /ID# 236266

    Montreal, Quebec, H2W 1V1

  • Montreal Neurological Institut /ID# 236329

    Montreal, Quebec, H3A 2B4

  • Ottawa Headache Centre Research Inc /ID# 236432

    Ottawa, Ontario, K2G 6E2

  • Vancouver Island Health Authority /ID# 238053

    Victoria, British Columbia, V8R 1J8

Other trials in Canada

Russia5 sites

  • Kazan State Medical University /ID# 236298

    Kazan', Tatarstan, Respublika, 420012

  • State Autonomous Healthcare Institution Republican Clinical Neurology Centre /ID# 236354

    Kazan', Tatarstan, Respublika, 420021

  • University Headache Clinic /ID# 236371

    Moscow, 119221

  • Clinics Chaika /ID# 236394

    Moscow, 125047

  • Central Clinical Hospital RZHD Medicine /ID# 237024

    Moscow, 129128

Other trials in Russia

Taiwan5 sites

  • Kuang-Tien General Hospital /ID# 236309

    Taichung, 433

  • Tainan Sin Lau Hospital /ID# 236358

    Tainan, 70142

  • Chi-Mei Medical Center /ID# 236724

    Tainan, 71004

  • Taipei Veterans General Hosp /ID# 237236

    Taipei, 11217

  • Tri-Service General Hospital /ID# 237657

    Taipei, 11490

Other trials in Taiwan

France4 sites

  • Hôpital Pierre Wertheimer /ID# 236969

    Bron, 69677

  • CHU Gabriel Montpied /ID# 237323

    Clermont-Ferrand, 63000

  • AP-HM - Hopital de la Timone /ID# 236285

    Marseille, Bouches-du-Rhone, 13385

  • CH Annecy Genevois Site Annecy /ID# 236385

    Pringy, Haute-Savoie, 74374

Other trials in France

Australia2 sites

  • The Royal Melbourne Hospital /ID# 236859

    Parkville, Victoria, 3050

  • Royal North Shore Hospital /ID# 237008

    St Leonards, New South Wales, 2065

Other trials in Australia

United Kingdom2 sites

  • Walton Centre /ID# 236468

    Liverpool, L9 7LJ

  • King's College Hospital NHS Foundation Trust /ID# 236301

    London, SE5 9RS

Other trials in United Kingdom

Denmark1 site

  • Rigshospitalet Glostrup /ID# 236411

    Glostrup Municipality, Capital Region, 2600

Other trials in Denmark

Sweden1 site

  • Stortorgets Neurologmottagning /ID# 236454

    Helsingborg, 252 20

Other trials in Sweden

About this study

Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Atogepant for the Prevention of Chronic Migraine (Progress)

This study evaluated the efficacy, safety and tolerability of atogepant in participants with chronic migraine. This study included a 12-week treatment period.

Being tested
Atogepant 30 mg, Atogepant 60 mg, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Atogepant 30 mgDrug

    Tablets containing 30 mg atogepant

  • Atogepant 60 mgDrug

    Tablets containing 60 mg atogepant

  • PlaceboDrug

    30 mg/60 mg tablets containing atogepant-matching placebo

Study groups in NCT03855137
Study groupRoleWhat they receive
PlaceboPlacebo comparatorParticipants received atogepant-matching placebo tablets, orally, twice daily (BID) for 12 weeks in a double-blind (DB) treatment period.
Receives: Drug: Placebo
Atogepant 30 mg BIDActive comparatorParticipants received atogepant 30 mg tablet, orally, BID and atogepant-matching placebo tablets orally, BID for up to 12 weeks in a DB treatment period.
Receives: Drug: Atogepant 30 mg; Drug: Placebo
Atogepant 60 mg QDActive comparatorParticipants received atogepant 60 mg, orally, once daily (QD) along with atogepant-matching placebo 30 mg as morning dose followed by atogepant-matching placebo 30 mg and 60 mg as evening doses for up to 12 weeks in a DB treatment period.
Receives: Drug: Atogepant 60 mg; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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. A contrast from Mixed-effects model for repeated measures (MMRM) was used to obtain the average treatment effects across the 12-week treatment period.

    Measured: Baseline to Week 12

  2. Change From Baseline in Mean Monthly Migraine Days Across 12-Week Treatment Period in Off-Treatment Hypothetical Estimand 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. A contrast from Mixed-effects model for repeated measures (MMRM) was used to obtain the average treatment effects across the 12-week treatment period.

    Measured: Baseline to Week 12

Secondary outcomes (10)

  1. Change From Baseline in Mean Monthly Headache Days Across 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. A contrast from MMRM was used to obtain the average treatment effects across the 12-week treatment period.

    Measured: Baseline to Week 12

  2. Change From Baseline in Mean Monthly Headache Days Across 12-Week Treatment Period in Off-Treatment Hypothetical Estimand 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. A contrast from MMRM was used to obtain the average treatment effects across the 12-week treatment period.

    Measured: Baseline to Week 12

  3. Change From Baseline in Mean Monthly Acute Medication Use Days Across 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. A contrast from MMRM was used to obtain the average treatment effects across the 12-week treatment period.

    Measured: Baseline to Week 12

  4. Change From Baseline in Mean Monthly Acute Medication Use Days Across 12-Week Treatment Period in Off-treatment Hypothetical Estimand 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. A contrast from MMRM was used to obtain the average treatment effects across the 12-week treatment period.

    Measured: Baseline to Week 12

  5. Percentage of Participants With at Least a 50% Reduction in 3-Month Average of Monthly Migraine Days in mITT Population

    Data is reported for 50% responders averaged at each 4-week period. 50% responders are participants with at least a 50 percent 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 is 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. The values are rounded off to the first decimal value.

    Measured: Baseline to Week 12

  6. Percentage of Participants With at Least a 50% Reduction in 3-Month Average of Monthly Migraine Days in Off-Treatment Hypothetical Estimand Population

    Data is reported for 50% responders averaged at each 4-week period. 50% responders are participants with at least a 50 percent 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 is 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. The values are rounded off to the first decimal value.

    Measured: Baseline to Week 12

  7. Change From Baseline in Migraine Specific Quality of Life Questionnaire, Version 2.1 (MSQ v2.1) Role Function-Restrictive Domain Score at Week 12 in Off-Treatment Hypothetical Estimand 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. A contrast from MMRM was used to obtain the average treatment effects across the 12-week treatment period.

    Measured: At Week 12

  8. Change From Baseline in Mean Monthly Performance of Daily Activities Domain Score of the AIM-D Across 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). A contrast from MMRM was used to obtain the average treatment effects across the 12-week treatment period.

    Measured: Baseline to Week 12

  9. Change From Baseline in Mean Monthly Physical Impairment Domain Score of the AIM-D Across 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). A contrast from MMRM was used to obtain the average treatment effects across the 12-week treatment period.

    Measured: Baseline to Week 12

  10. Change From Baseline in the Headache Impact Test (HIT-6) Total Score at Week 12 in Off-Treatment Hypothetical Estimand 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.

    Measured: At Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2019
  2. Study start11 Mar 2019
  3. Primary completion20 Jan 2022
  4. Study completion20 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
778 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03855137
Sponsor's protocol ID
3101-303-002
Other IDs
2018-004337-32, 2018
Status last verified
Jan 2023
First submitted
25 Feb 2019
Last updated
14 Feb 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Schlachter L, Stodtmann S, Voelkner A, Jonsson F, Lagraauw HM, Boinpally RR. Population Pharmacokinetics of Atogepant for the Prevention of Migraine. Clin Pharmacokinet. 2026 Jan;65(1):149-164. doi: 10.1007/s40262-025-01566-5. Epub 2025 Nov 12.

    PubMed 41222899

  • UpToDate(R). Nurse Pract. 2023 Jul 1;48(7):16. doi: 10.1097/01.NPR.0000000000000072. No abstract available.

    PubMed 40471213

  • Goadsby PJ, Jurgens TP, Brand-Schieber E, Nagy K, Liu Y, Boinpally R, Stodtmann S, Trugman JM. Efficacy of ubrogepant and atogepant in males and females with migraine: A secondary analysis of randomized clinical trials. Cephalalgia. 2025 Feb;45(2):3331024251320610. doi: 10.1177/03331024251320610.

    PubMed 39982105

  • Lipton RB, Gandhi P, Tassorelli C, Reuter U, Harriott AM, Holle-Lee D, Gottschalk CH, Neel B, Liu Y, Guo H, Stokes J, Nagy K, Dabruzzo B, Smith JH. Early Improvements With Atogepant for the Preventive Treatment of Migraine: Results From 3 Randomized Phase 3 Trials. Neurology. 2025 Jan 28;104(2):e210212. doi: 10.1212/WNL.0000000000210212. Epub 2024 Dec 23.

    PubMed 39715475

  • Peterlin BL, Bond DS, Ailani J, Dodick DW, Liu Y, De Abreu Ferreira R, Smith JH, Dabruzzo B, Goadsby PJ, Trugman JM. Weight loss with atogepant during the preventive treatment of migraine: A pooled analysis. Cephalalgia. 2024 Dec;44(12):3331024241299753. doi: 10.1177/03331024241299753.

    PubMed 39648629

  • Gottschalk C, Gandhi P, Pozo-Rosich P, Christie S, Tassorelli C, Stokes J, Liu Y, Luo L, Nagy K, Trugman JM, Lipton RB. Effect of preventive treatment with atogepant on quality of life, daily functioning, and headache impact across the spectrum of migraine: Findings from three double-blind, randomized, phase 3 trials. Cephalalgia. 2024 Dec;44(12):3331024241300305. doi: 10.1177/03331024241300305.

    PubMed 39648617

  • Goadsby PJ, Friedman DI, Holle-Lee D, Demarquay G, Ashina S, Sakai F, Neel B, Gandhi P, Dabruzzo B, Smith JH, Liu Y, Trugman JM. Efficacy of Atogepant in Chronic Migraine With and Without Acute Medication Overuse in the Randomized, Double-Blind, Phase 3 PROGRESS Trial. Neurology. 2024 Jul 23;103(2):e209584. doi: 10.1212/WNL.0000000000209584. Epub 2024 Jun 26.

    PubMed 38924724

  • Pozo-Rosich P, Ailani J, Ashina M, Goadsby PJ, Lipton RB, Reuter U, Guo H, Schwefel B, Lu K, Boinpally R, Miceli R, De Abreu Ferreira R, McCusker E, Yu SY, Severt L, Finnegan M, Trugman JM. Atogepant for the preventive treatment of chronic migraine (PROGRESS): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2023 Sep 2;402(10404):775-785. doi: 10.1016/S0140-6736(23)01049-8. Epub 2023 Jul 26.

    PubMed 37516125

  • Boinpally R, McNamee B, Yao L, Butler M, McGeeney D, Borbridge L, Periclou A. A Single Supratherapeutic Dose of Atogepant Does Not Affect Cardiac Repolarization in Healthy Adults: Results From a Randomized, Single-Dose, Phase 1 Crossover Trial. Clin Pharmacol Drug Dev. 2021 Sep;10(9):1099-1107. doi: 10.1002/cpdd.940. Epub 2021 May 4.

    PubMed 33942560

  • Min KC, Kraft WK, Bondiskey P, Colon-Gonzalez F, Liu W, Xu J, Panebianco D, Mixson L, Dockendorf MF, Matthews CZ, Boinpally R. Atogepant Is Not Associated With Clinically Meaningful Alanine Aminotransferase Elevations in Healthy Adults. Clin Transl Sci. 2021 Mar;14(2):599-605. doi: 10.1111/cts.12917. Epub 2020 Nov 24.

    PubMed 33142014

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Atogepant 30 mg and Atogepant 60 mg in people with Chronic Migraine, run by Allergan at 150 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 150 sites in United States, Japan, China, Czechia, Poland and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Mean Monthly Migraine Days Across 12-Week Treatment Period in mITT Population (time frame: Baseline to Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03855137, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2023.

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