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

• ClinicalTrials.gov Identifier: NCT03855137
• Recruitment Status: Completed
• First Posted: February 26, 2019
• Results First Posted: February 14, 2023
• Last Update Posted: February 14, 2023
• Sponsor: Allergan
• Information provided by (Responsible Party): Allergan

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Chronic Migraine	Drug: Atogepant 30 mg; Drug: Atogepant 60 mg; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 778 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: March 11, 2019
• Actual Primary Completion Date: January 20, 2022
• Actual Study Completion Date: January 20, 2022

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Placebo; Participants received atogepant-matching placebo tablets, orally, twice daily (BID) for 12 weeks in a double-blind (DB) treatment period.	Drug: Placebo; 30 mg/60 mg tablets containing atogepant-matching placebo
Active Comparator: Atogepant 30 mg BID; Participants received atogepant 30 mg tablet, orally, BID and atogepant-matching placebo tablets orally, BID for up to 12 weeks in a DB treatment period.	Drug: Atogepant 30 mg; Tablets containing 30 mg atogepant; Drug: Placebo; 30 mg/60 mg tablets containing atogepant-matching placebo
Active Comparator: Atogepant 60 mg QD; Participants 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.	Drug: Atogepant 60 mg; Tablets containing 60 mg atogepant; Drug: Placebo; 30 mg/60 mg tablets containing atogepant-matching placebo

Outcome Measures

Primary Outcome Measures :

1. Change From Baseline in Mean Monthly Migraine Days Across 12-Week Treatment Period in mITT Population [ Time Frame: Baseline to Week 12 ]
   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.
2. Change From Baseline in Mean Monthly Migraine Days Across 12-Week Treatment Period in Off-Treatment Hypothetical Estimand Population [ Time Frame: Baseline to Week 12 ]
   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.

Secondary Outcome Measures :

1. Change From Baseline in Mean Monthly Headache Days Across 12-Week Treatment Period in mITT Population [ Time Frame: Baseline to Week 12 ]
   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.
2. Change From Baseline in Mean Monthly Headache Days Across 12-Week Treatment Period in Off-Treatment Hypothetical Estimand Population [ Time Frame: Baseline to Week 12 ]
   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.
3. Change From Baseline in Mean Monthly Acute Medication Use Days Across 12-Week Treatment Period in mITT Population [ Time Frame: Baseline to Week 12 ]
   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.
4. Change From Baseline in Mean Monthly Acute Medication Use Days Across 12-Week Treatment Period in Off-treatment Hypothetical Estimand Population [ Time Frame: Baseline to Week 12 ]
   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.
5. Percentage of Participants With at Least a 50% Reduction in 3-Month Average of Monthly Migraine Days in mITT Population [ Time Frame: Baseline to Week 12 ]
   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.
6. Percentage of Participants With at Least a 50% Reduction in 3-Month Average of Monthly Migraine Days in Off-Treatment Hypothetical Estimand Population [ Time Frame: Baseline to Week 12 ]
   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.
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 [ Time Frame: At Week 12 ]
   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.
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 [ Time Frame: Baseline to Week 12 ]
   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.
9. Change From Baseline in Mean Monthly Physical Impairment Domain Score of the AIM-D Across 12-Week Treatment Period in mITT Population [ Time Frame: Baseline to Week 12 ]
   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.
10. Change From Baseline in the Headache Impact Test (HIT-6) Total Score at Week 12 in Off-Treatment Hypothetical Estimand Population [ Time Frame: At Week 12 ]
    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.

Eligibility Criteria

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

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

United States, Arizona

Barrow Neuro Institute /ID# 236776

Phoenix, Arizona, United States, 85013

United States, Arkansas

Baptist Health Center for Clinical Research /ID# 237361

Little Rock, Arkansas, United States, 72205

United States, California

California Headache and Balance Center /ID# 236246

Fresno, California, United States, 93720

Wr-Pri Llc /Id# 236008

Los Alamitos, California, United States, 90720

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

Newport Beach, California, United States, 92660

Schuster Medical Research Institute /ID# 236447

Sherman Oaks, California, United States, 91403

United States, Colorado

Alpine Clinical Research Center /ID# 234346

Boulder, Colorado, United States, 80301-1880

United States, District of Columbia

George Washington University Medical Faculty Associates /ID# 238011

Washington, District of Columbia, United States, 20037-3201

United States, Florida

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

Saint Petersburg, Florida, United States, 33709-3113

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

Tampa, Florida, United States, 33634

Premiere Research Institute - Palm Beach /ID# 238192

West Palm Beach, Florida, United States, 33407-3209

United States, Georgia

NeuroTrials Research Inc. /ID# 237364

Atlanta, Georgia, United States, 30328

United States, Indiana

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

Indianapolis, Indiana, United States, 46256-4692

United States, Kansas

Collective Medical Research /ID# 236400

Prairie Village, Kansas, United States, 66208

United States, Louisiana

Ochsner Clinic Foundation /ID# 236543

Covington, Louisiana, United States, 70433-8107

United States, Massachusetts

Beth Israel Deaconess Medical Center /ID# 237540

Boston, Massachusetts, United States, 02215-5400

BTC of New Bedford /ID# 236384

New Bedford, Massachusetts, United States, 02740

United States, Minnesota

Clinical Research Institute, Inc /ID# 238299

Minneapolis, Minnesota, United States, 55402-2606

United States, Mississippi

Headache Neurology Research Institute /ID# 236464

Ridgeland, Mississippi, United States, 39157

United States, Nevada

Nevada Headache Institute /ID# 236420

Las Vegas, Nevada, United States, 89113

United States, New Hampshire

Dartmouth-Hitchcock Medical Center /ID# 237444

Lebanon, New Hampshire, United States, 03756

United States, New Mexico

Albuquerque Clinical Trials, Inc /ID# 236853

Albuquerque, New Mexico, United States, 87102

United States, New York

Albany Medical Center Rheumatology /ID# 236540

Albany, New York, United States, 12208-3412

Dent Neurosciences Research Center, Inc. /ID# 237040

Amherst, New York, United States, 14226

United States, North Carolina

Headache Wellness Center /ID# 236431

Greensboro, North Carolina, United States, 27405

Raleigh Neurology Associates /ID# 237141

Raleigh, North Carolina, United States, 27607

United States, Ohio

Stetson-University of Cincinnati /ID# 236453

Cincinnati, Ohio, United States, 45219

United States, Pennsylvania

Abington Neurological Associates - Abington /ID# 236258

Abington, Pennsylvania, United States, 19001

Preferred Primary Care Physicians, Inc. /ID# 236439

Pittsburgh, Pennsylvania, United States, 15236

United States, Tennessee

WR-ClinSearch /ID# 238288

Chattanooga, Tennessee, United States, 37421-1605

Clinical Neuroscience Solutions - Memphis /ID# 237478

Memphis, Tennessee, United States, 38119

United States, Texas

DiscoveResearch, Inc /ID# 236274

Bryan, Texas, United States, 77802

Texas Neurology /ID# 236359

Dallas, Texas, United States, 75214

University of Texas Southwestern Medical Center /ID# 236941

Dallas, Texas, United States, 75390-7208

United States, Utah

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

Salt Lake City, Utah, United States, 84109

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

Salt Lake City, Utah, United States, 84121

Highland Clinical Research /ID# 237816

Salt Lake City, Utah, United States, 84124

United States, Virginia

MedStar Georgetown Neurology /ID# 236324

McLean, Virginia, United States, 22101

Sentara Neurology Specialists - Virginia Beach /ID# 234349

Virginia Beach, Virginia, United States, 23456-0019

United States, Washington

Northwest Clinical Research Center /ID# 237581

Bellevue, Washington, United States, 98007

Puget Sound Neurology /ID# 236321

Tacoma, Washington, United States, 25328

Australia, New South Wales

Royal North Shore Hospital /ID# 237008

St Leonards, New South Wales, Australia, 2065

Australia, Victoria

The Royal Melbourne Hospital /ID# 236859

Parkville, Victoria, Australia, 3050

Canada, Alberta

CHAMP Clinic /ID# 236252

Calgary, Alberta, Canada, T3M 1M4

Canada, British Columbia

Vancouver Island Health Authority /ID# 238053

Victoria, British Columbia, Canada, V8R 1J8

Canada, Ontario

Ottawa Headache Centre Research Inc /ID# 236432

Ottawa, Ontario, Canada, K2G 6E2

Canada, Quebec

Clinique des cephalees de Montreal /ID# 236266

Montreal, Quebec, Canada, H2W 1V1

Montreal Neurological Institut /ID# 236329

Montreal, Quebec, Canada, H3A 2B4

China, Beijing

Peking University Third Hospital /ID# 238150

Beijing, Beijing, China, 100191

Chinese PLA General Hospital /ID# 238237

Beijing, Beijing, China, 100853

China, Guangdong

Guangzhou First People's Hospital /ID# 236510

Guangzhou, Guangdong, China, 510180

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

Guangzhou, Guangdong, China, 510260

China, Hebei

Hubei General Hospital /ID# 236486

Wuhan, Hebei, China, 430060

China, Henan

The First Affiliated Hospital of Zhengzhou University /ID# 237025

Zhengzhou, Henan, China, 450052

China, Jiangsu

Jiangsu Province Hospital /ID# 237846

Nanjing, Jiangsu, China, 210029

China, Jilin

The Second Hospital of Jilin University /ID# 236520

Changchun, Jilin, China, 130022

China, Shanghai

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

Shanghai, Shanghai, China, 200065

China, Shanxi

The Second Hospital of Shanxi Medical University /ID# 236529

Taiyuan, Shanxi, China, 030000

China, Zhejiang

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

Hangzhou, Zhejiang, China, 310009

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

Hangzhou, Zhejiang, China, 310020

China

Beijing Friendship Hospital /ID# 237264

Beijing, China, 100032

The Second Hospital of Soochow University /ID# 234296

Suzhou, China, 215004

Tianjin Huanhu Hospital (THH) /ID# 236524

Tianjin, China, 300350

Tongji Hospital Tongji Medical College of HUST /ID# 237835

Wuhan, China, 430030

Czechia

NEUROHK s.r.o. /ID# 236290

Hradec Kralove, Czechia, 500 09

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

Kladno, Czechia, 272 01

CCR Ostrava, s.r.o. /ID# 234291

Ostrava, Czechia, 702 00

CLINTRIAL s.r.o. /ID# 237793

Prague 10, Czechia, 100 00

CCR Czech a.s /ID# 236249

Prague 4, Czechia, 140 00

FORBELI s.r.o. /ID# 236427

Prague, Czechia, 160 00

CCR Prague s.r.o. /ID# 236250

Praha, Czechia, 130 00

Thomayerova nemocnice /ID# 237175

Praha, Czechia, 140 59

NeuroMed Zlin s.r.o. /ID# 236416

Zlin, Czechia, 760 01

Denmark

Rigshospitalet Glostrup /ID# 236411

Glostrup, Hovedstaden, Denmark, 2600

France

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

Marseille CEDEX 05, Bouches-du-Rhone, France, 13385

CH Annecy Genevois Site Annecy /ID# 236385

PRINGY cedex, Haute-Savoie, France, 74374

Hôpital Pierre Wertheimer /ID# 236969

Bron, France, 69677

CHU Gabriel Montpied /ID# 237323

Clermont Ferrand, France, 63000

Germany

Charite Universitaetsklinikum Berlin - Campus Virchow /ID# 237256

Berlin, Germany, 13353

Praxis Dr. Gendolla /ID# 236311

Essen, Germany, 45133

Universitaetsklinikum Essen /ID# 237209

Essen, Germany, 45147

CTC North GmbH & Co. KG /ID# 236328

Hamburg, Germany, 20251

Vitos Orthopaedische Klinik Kassel gemeinnuetzige GmbH /ID# 236723

Kassel, Germany, 34131

Schmerzklinik Kiel /ID# 236444

Kiel, Germany, 24149

LMU Klinikum Campus Grosshadern /ID# 236293

München, Germany, 81377

Italy

Azienda Ospedaliera Universitaria Consorziale Policlinico /ID# 237492

Bari, Italy, 70124

Azienda Ospedaliero Universitaria Careggi /ID# 237598

Florence, Italy, 50134

Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 237291

Milan, Italy, 20133

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

Napoli, Italy, 80138

Universita di Pavia /ID# 236363

Pavia, Italy, 27100

IRCCS San Raffaele Pisana /ID# 236552

Rome, Italy, 00163

Japan

Takanoko Hospital /ID# 234564

Matsuyama-shi, Ehime, Japan, 790-0925

Fukuiken Saiseikai Hospital /ID# 236794

Fukui-shi, Fukui, Japan, 918-8235

Higashi Sapporo Neurology and Neurosurgery Clinic /ID# 234549

Sapporo-shi, Hokkaido, Japan, 003-0003

Konan Medical Center /ID# 236230

Kobe-shi, Hyogo, Japan, 658-0064

Atsuchi Neurosurgical Hospital /ID# 234779

Kagoshima-shi, Kagoshima, Japan, 892-0842

Tokai University Hospital /ID# 237595

Isehara-shi, Kanagawa, Japan, 259-1193

Fujitsu Clinic /ID# 237443

Kawasaki-shi, Kanagawa, Japan, 211-8588

Umenotsuji Clinic /ID# 234495

Kochi-shi, Kochi, Japan, 780-8011

Sendai Headache and Neurology Clinic Medical Corporation /ID# 234496

Sendai-shi, Miyagi, Japan, 982-0014

Saitama Medical University Hospital /ID# 237019

Iruma-gun, Saitama, Japan, 350-0495

Saitama Neuropsychiatric Institute /Id# 234550

Saitama-shi, Saitama, Japan, 338-8577

Japanese Red Cross Shizuoka Hospital /ID# 234372

Shizuoka-shi, Shizuoka, Japan, 420-0853

Dokkyo Medical University Hospital /ID# 236810

Shimotsuga-gun, Tochigi, Japan, 321-0293

Niwa Family Clinic /ID# 234552

Chofu-shi, Tokyo, Japan, 182-0006

Tokyo Headache Clinic /ID# 234555

Shibuya-ku, Tokyo, Japan, 151-0051

Keio University Hospital /ID# 237210

Shinjuku-ku, Tokyo, Japan, 160-8582

Nagaseki Headache Clinic /ID# 234561

Kai-shi, Yamanashi, Japan, 400-0124

DOI Internal Medicine-Neurology Clinic /ID# 234562

Hiroshima, Japan, 730-0031

Hiroshima Neurology Clinic /ID# 234563

Hiroshima, Japan, 732-0822

Tanaka Neurosurgical clinic /ID# 234760

Kagoshima, Japan, 892-0844

Tatsuoka Neurology Clinic /ID# 234782

Kyoto, Japan, 600-8811

Tominaga Hospital /ID# 234781

Osaka, Japan, 556-0017

Shinagawa Strings Clinic /ID# 234780

Tokyo, Japan, 108-0075

Korea, Republic of

Dongtan Sacred Heart Hospital /ID# 238097

Hwaseong, Gyeonggido, Korea, Republic of, 18450

Kangbuk Samsung Hospital /ID# 237754

Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03181

Yonsei University Health System Severance Hospital /ID# 237839

Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03722

Pusan National University Hospital /ID# 237120

Busan, Korea, Republic of, 49241

Nowon Eulji Medical Center, Eulji University /ID# 236306

Seoul, Korea, Republic of, 01830

Seoul National University Hospital /ID# 237786

Seoul, Korea, Republic of, 03080

Samsung Medical Center /ID# 237785

Seoul, Korea, Republic of, 06351

Poland

NZOZ Vitamed /ID# 237041

Bydgoszcz, Kujawsko-pomorskie, Poland, 85-079

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

Lublin, Lubelskie, Poland, 20-582

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

Krakow, Malopolskie, Poland, 30-539

Centrum Leczenia Padaczki i Migreny /ID# 236386

Krakow, Malopolskie, Poland, 31-209

Centrum Medyczne Pratia Gdynia /ID# 237077

Gdynia, Pomorskie, Poland, 81-338

Silmedic Sp. z o.o. /ID# 237343

Katowice, Slaskie, Poland, 40-282

Solumed Centrum Medyczne /ID# 236452

Poznan, Wielkopolskie, Poland, 60-529

EuroMedis sp. z o.o. /ID# 236417

Szczecin, Zachodniopomorskie, Poland, 70-111

Russian Federation

Kazan State Medical University /ID# 236298

Kazan, Tatarstan, Respublika, Russian Federation, 420012

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

Kazan, Tatarstan, Respublika, Russian Federation, 420021

University Headache Clinic /ID# 236371

Moscow, Russian Federation, 119221

Clinics Chaika /ID# 236394

Moscow, Russian Federation, 125047

Central Clinical Hospital RZHD Medicine /ID# 237024

Moscow, Russian Federation, 129128

Spain

Hospital Clínico Universitario de Santiago-CHUS /ID# 237623

Santiago de Compostela, A Coruna, Spain, 15706

CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 237645

Pamplona, Navarra, Spain, 31008

Hospital Universitario Vall d'Hebron /ID# 236467

Barcelona, Spain, 08035

Hospital Universitario Virgen del Rocio /ID# 237106

Sevilla, Spain, 41013

Hospital Clinico Universitario de Valencia /ID# 237400

Valencia, Spain, 46010

Hospital Universitario y Politecnico La Fe /ID# 237087

Valencia, Spain, 46026

Hospital Clinico Universitario de Valladolid /ID# 234406

Valladolid, Spain, 47003

Hospital Clinico Universitario Lozano Blesa /ID# 237373

Zaragoza, Spain, 50009

Sweden

Stortorgets Neurologmottagning /ID# 236454

Helsingborg, Sweden, 252 20

Taiwan

Kuang-Tien General Hospital /ID# 236309

Taichung City, Taiwan, 433

Tainan Sin Lau Hospital /ID# 236358

Tainan City, Taiwan, 70142

Chi-Mei Medical Center /ID# 236724

Tainan, Taiwan, 71004

Taipei Veterans General Hosp /ID# 237236

Taipei City, Taiwan, 11217

Tri-Service General Hospital /ID# 237657

Taipei City, Taiwan, 11490

United Kingdom

Walton Centre /ID# 236468

Liverpool, United Kingdom, L9 7LJ

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

London, United Kingdom, SE5 9RS

Sponsors and Collaborators

Allergan

Investigators

• Study Director: ALLERGAN INC.; Allergan

  Study Documents (Full-Text)

Documents provided by Allergan:

Study Protocol  [PDF] May 29, 2020

Statistical Analysis Plan  [PDF] January 24, 2022

More Information

Additional Information:

Related Information 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT03855137
• Obsolete Identifiers: NCT04961671
• Other Study ID Numbers: 3101-303-002; 2018-004337-32 ( EudraCT Number )
• First Posted: February 26, 2019
• Results First Posted: February 14, 2023
• Last Update Posted: February 14, 2023
• Last Verified: January 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)
• Time Frame: For details on when studies are available for sharing visit, please refer to the link below.
• 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 (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
• URL: https://vivli.org/ourmember/abbvie/

• 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

Additional relevant MeSH terms:

Migraine Disorders; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases