Efficacy, Safety, and Tolerability of Atogepant for the Prevention of Chronic Migraine
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)
2 other identifiers
interventional
778
17 countries
150
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2019
Typical duration for phase_3
150 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2019
CompletedFirst Posted
Study publicly available on registry
February 26, 2019
CompletedStudy Start
First participant enrolled
March 11, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 20, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 20, 2022
CompletedResults Posted
Study results publicly available
February 14, 2023
CompletedFebruary 14, 2023
January 1, 2023
2.9 years
February 25, 2019
January 18, 2023
January 18, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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.
Baseline to Week 12
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.
Baseline to Week 12
Secondary Outcomes (10)
Change From Baseline in Mean Monthly Headache Days Across 12-Week Treatment Period in mITT Population
Baseline to Week 12
Change From Baseline in Mean Monthly Headache Days Across 12-Week Treatment Period in Off-Treatment Hypothetical Estimand Population
Baseline to Week 12
Change From Baseline in Mean Monthly Acute Medication Use Days Across 12-Week Treatment Period in mITT Population
Baseline to Week 12
Change From Baseline in Mean Monthly Acute Medication Use Days Across 12-Week Treatment Period in Off-treatment Hypothetical Estimand Population
Baseline to Week 12
Percentage of Participants With at Least a 50% Reduction in 3-Month Average of Monthly Migraine Days in mITT Population
Baseline to Week 12
- +5 more secondary outcomes
Study Arms (3)
Placebo
PLACEBO COMPARATORParticipants received atogepant-matching placebo tablets, orally, twice daily (BID) for 12 weeks in a double-blind (DB) treatment period.
Atogepant 30 mg BID
ACTIVE 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.
Atogepant 60 mg QD
ACTIVE 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.
Interventions
30 mg/60 mg tablets containing atogepant-matching placebo
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (150)
Barrow Neuro Institute /ID# 236776
Phoenix, Arizona, 85013, United States
Baptist Health Center for Clinical Research /ID# 237361
Little Rock, Arkansas, 72205, United States
California Headache and Balance Center /ID# 236246
Fresno, California, 93720, United States
Wr-Pri Llc /Id# 236008
Los Alamitos, California, 90720, United States
Pharmacology Research Institute (PRI) - Newport Beach (Wake) /ID# 237692
Newport Beach, California, 92660, United States
Schuster Medical Research Institute /ID# 236447
Sherman Oaks, California, 91403, United States
Alpine Clinical Research Center /ID# 234346
Boulder, Colorado, 80301-1880, United States
George Washington University Medical Faculty Associates /ID# 238011
Washington D.C., District of Columbia, 20037-3201, United States
Accel Research Sites - St Petersburg Clinical Research Unit /ID# 237161
St. Petersburg, Florida, 33709-3113, United States
Accel Research Sites - Tampa Clinical Research Unit /ID# 237485
Tampa, Florida, 33634, United States
Premiere Research Institute - Palm Beach /ID# 238192
West Palm Beach, Florida, 33407-3209, United States
NeuroTrials Research Inc. /ID# 237364
Atlanta, Georgia, 30328, United States
Josephson-Wallack-Munshower Neurology - NE /ID# 238234
Indianapolis, Indiana, 46256-4692, United States
Collective Medical Research /ID# 236400
Prairie Village, Kansas, 66208, United States
Ochsner Clinic Foundation /ID# 236543
Covington, Louisiana, 70433-8107, United States
Beth Israel Deaconess Medical Center /ID# 237540
Boston, Massachusetts, 02215-5400, United States
BTC of New Bedford /ID# 236384
New Bedford, Massachusetts, 02740, United States
Clinical Research Institute, Inc /ID# 238299
Minneapolis, Minnesota, 55402-2606, United States
Headache Neurology Research Institute /ID# 236464
Ridgeland, Mississippi, 39157, United States
Nevada Headache Institute /ID# 236420
Las Vegas, Nevada, 89113, United States
Dartmouth-Hitchcock Medical Center /ID# 237444
Lebanon, New Hampshire, 03756, United States
Albuquerque Clinical Trials, Inc /ID# 236853
Albuquerque, New Mexico, 87102, United States
Albany Medical Center Rheumatology /ID# 236540
Albany, New York, 12208-3412, United States
Dent Neurosciences Research Center, Inc. /ID# 237040
Amherst, New York, 14226, United States
Headache Wellness Center /ID# 236431
Greensboro, North Carolina, 27405, United States
Raleigh Neurology Associates /ID# 237141
Raleigh, North Carolina, 27607, United States
Stetson-University of Cincinnati /ID# 236453
Cincinnati, Ohio, 45219, United States
Abington Neurological Associates - Abington /ID# 236258
Abington, Pennsylvania, 19001, United States
Preferred Primary Care Physicians, Inc. /ID# 236439
Pittsburgh, Pennsylvania, 15236, United States
WR-ClinSearch /ID# 238288
Chattanooga, Tennessee, 37421-1605, United States
Clinical Neuroscience Solutions - Memphis /ID# 237478
Memphis, Tennessee, 38119, United States
DiscoveResearch, Inc /ID# 236274
Bryan, Texas, 77802, United States
Texas Neurology /ID# 236359
Dallas, Texas, 75214, United States
University of Texas Southwestern Medical Center /ID# 236941
Dallas, Texas, 75390-7208, United States
J. Lewis Research, Inc. / Foothill Family Clinic /ID# 236395
Salt Lake City, Utah, 84109, United States
J. Lewis Research, Inc. Foothill Family Clinic South /ID# 236297
Salt Lake City, Utah, 84121, United States
Highland Clinical Research /ID# 237816
Salt Lake City, Utah, 84124, United States
MedStar Georgetown Neurology /ID# 236324
McLean, Virginia, 22101, United States
Sentara Neurology Specialists - Virginia Beach /ID# 234349
Virginia Beach, Virginia, 23456-0019, United States
Northwest Clinical Research Center /ID# 237581
Bellevue, Washington, 98007, United States
Puget Sound Neurology /ID# 236321
Tacoma, Washington, 25328, United States
Royal North Shore Hospital /ID# 237008
St Leonards, New South Wales, 2065, Australia
The Royal Melbourne Hospital /ID# 236859
Parkville, Victoria, 3050, Australia
CHAMP Clinic /ID# 236252
Calgary, Alberta, T3M 1M4, Canada
Vancouver Island Health Authority /ID# 238053
Victoria, British Columbia, V8R 1J8, Canada
Ottawa Headache Centre Research Inc /ID# 236432
Ottawa, Ontario, K2G 6E2, Canada
Clinique des cephalees de Montreal /ID# 236266
Montreal, Quebec, H2W 1V1, Canada
Montreal Neurological Institut /ID# 236329
Montreal, Quebec, H3A 2B4, Canada
Peking University Third Hospital /ID# 238150
Beijing, Beijing Municipality, 100191, China
Chinese PLA General Hospital /ID# 238237
Beijing, Beijing Municipality, 100853, China
Guangzhou First People's Hospital /ID# 236510
Guangzhou, Guangdong, 510180, China
The Second Affiliated Hospital of Guangzhou Medical University /ID# 238133
Guangzhou, Guangdong, 510260, China
Hubei General Hospital /ID# 236486
Wuhan, Hebei, 430060, China
The First Affiliated Hospital of Zhengzhou University /ID# 237025
Zhengzhou, Henan, 450052, China
Jiangsu Province Hospital /ID# 237846
Nanjing, Jiangsu, 210029, China
The Second Hospital of Jilin University /ID# 236520
Changchun, Jilin, 130022, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 237847
Shanghai, Shanghai Municipality, 200065, China
The Second Hospital of Shanxi Medical University /ID# 236529
Taiyuan, Shanxi, 030000, China
The second Affiliated hospital of Zhejiang University school of Medicine /ID# 238260
Hangzhou, Zhejiang, 310009, China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine /ID# 236500
Hangzhou, Zhejiang, 310020, China
Beijing Friendship Hospital /ID# 237264
Beijing, 100032, China
The Second Hospital of Soochow University /ID# 234296
Suzhou, 215004, China
Tianjin Huanhu Hospital (THH) /ID# 236524
Tianjin, 300350, China
Tongji Hospital Tongji Medical College of HUST /ID# 237835
Wuhan, 430030, China
NEUROHK s.r.o. /ID# 236290
Hradec Králové, 500 09, Czechia
BRAIN-SOULTHERAPY s.r.o. /ID# 236380
Kladno, 272 01, Czechia
CCR Ostrava, s.r.o. /ID# 234291
Ostrava, 702 00, Czechia
CLINTRIAL s.r.o. /ID# 237793
Prague, 100 00, Czechia
CCR Prague s.r.o. /ID# 236250
Prague, 130 00, Czechia
CCR Czech a.s /ID# 236249
Prague, 140 00, Czechia
Thomayerova nemocnice /ID# 237175
Prague, 140 59, Czechia
FORBELI s.r.o. /ID# 236427
Prague, 160 00, Czechia
NeuroMed Zlin s.r.o. /ID# 236416
ZlĂn, 760 01, Czechia
Rigshospitalet Glostrup /ID# 236411
Glostrup Municipality, Capital Region, 2600, Denmark
AP-HM - Hopital de la Timone /ID# 236285
Marseille, Bouches-du-Rhone, 13385, France
CH Annecy Genevois Site Annecy /ID# 236385
Pringy, Haute-Savoie, 74374, France
HĂ´pital Pierre Wertheimer /ID# 236969
Bron, 69677, France
CHU Gabriel Montpied /ID# 237323
Clermont-Ferrand, 63000, France
Charite Universitaetsklinikum Berlin - Campus Virchow /ID# 237256
Berlin, 13353, Germany
Praxis Dr. Gendolla /ID# 236311
Essen, 45133, Germany
Universitaetsklinikum Essen /ID# 237209
Essen, 45147, Germany
CTC North GmbH & Co. KG /ID# 236328
Hamburg, 20251, Germany
Vitos Orthopaedische Klinik Kassel gemeinnuetzige GmbH /ID# 236723
Kassel, 34131, Germany
Schmerzklinik Kiel /ID# 236444
Kiel, 24149, Germany
LMU Klinikum Campus Grosshadern /ID# 236293
MĂĽnchen, 81377, Germany
Azienda Ospedaliera Universitaria Consorziale Policlinico /ID# 237492
Bari, 70124, Italy
Azienda Ospedaliero Universitaria Careggi /ID# 237598
Florence, 50134, Italy
Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 237291
Milan, 20133, Italy
AOU Universita degli Studi della Campania Luigi Vanvitelli /ID# 236361
Napoli, 80138, Italy
Universita di Pavia /ID# 236363
Pavia, 27100, Italy
IRCCS San Raffaele Pisana /ID# 236552
Rome, 00163, Italy
Takanoko Hospital /ID# 234564
Matsuyama, Ehime, 790-0925, Japan
Fukuiken Saiseikai Hospital /ID# 236794
Fukui-shi, Fukui, 918-8235, Japan
Higashi Sapporo Neurology and Neurosurgery Clinic /ID# 234549
Sapporo, Hokkaido, 003-0003, Japan
Konan Medical Center /ID# 236230
Kobe, HyĹŤgo, 658-0064, Japan
Atsuchi Neurosurgical Hospital /ID# 234779
Kagoshima, Kagoshima-ken, 892-0842, Japan
Tokai University Hospital /ID# 237595
Isehara-shi, Kanagawa, 259-1193, Japan
Fujitsu Clinic /ID# 237443
Kawasaki-shi, Kanagawa, 211-8588, Japan
Umenotsuji Clinic /ID# 234495
Kochi, Kochi, 780-8011, Japan
Sendai Headache and Neurology Clinic Medical Corporation /ID# 234496
Sendai, Miyagi, 982-0014, Japan
Saitama Medical University Hospital /ID# 237019
Iruma-gun, Saitama, 350-0495, Japan
Saitama Neuropsychiatric Institute /Id# 234550
Saitama-shi, Saitama, 338-8577, Japan
Japanese Red Cross Shizuoka Hospital /ID# 234372
Shizuoka, Shizuoka, 420-0853, Japan
Dokkyo Medical University Hospital /ID# 236810
Shimotsuga-gun, Tochigi, 321-0293, Japan
Niwa Family Clinic /ID# 234552
Chofu-shi, Tokyo, 182-0006, Japan
Tokyo Headache Clinic /ID# 234555
Shibuya-ku, Tokyo, 151-0051, Japan
Keio University Hospital /ID# 237210
Shinjuku-ku, Tokyo, 160-8582, Japan
Nagaseki Headache Clinic /ID# 234561
Kai-shi, Yamanashi, 400-0124, Japan
DOI Internal Medicine-Neurology Clinic /ID# 234562
Hiroshima, 730-0031, Japan
Hiroshima Neurology Clinic /ID# 234563
Hiroshima, 732-0822, Japan
Tanaka Neurosurgical clinic /ID# 234760
Kagoshima, 892-0844, Japan
Tatsuoka Neurology Clinic /ID# 234782
Kyoto, 600-8811, Japan
Tominaga Hospital /ID# 234781
Osaka, 556-0017, Japan
Shinagawa Strings Clinic /ID# 234780
Tokyo, 108-0075, Japan
Solumed Centrum Medyczne /ID# 236452
Poznan, Greater Poland Voivodeship, 60-529, Poland
NZOZ Vitamed /ID# 237041
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-079, Poland
Specjalistyczne Gabinety Sp. z o.o. /ID# 236348
Krakow, Lesser Poland Voivodeship, 30-539, Poland
Centrum Leczenia Padaczki i Migreny /ID# 236386
Krakow, Lesser Poland Voivodeship, 31-209, Poland
Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 236289
Lublin, Lublin Voivodeship, 20-582, Poland
Centrum Medyczne Pratia Gdynia /ID# 237077
Gdynia, Pomeranian Voivodeship, 81-338, Poland
Silmedic Sp. z o.o. /ID# 237343
Katowice, Silesian Voivodeship, 40-282, Poland
EuroMedis sp. z o.o. /ID# 236417
Szczecin, West Pomeranian Voivodeship, 70-111, Poland
Kazan State Medical University /ID# 236298
Kazan', Tatarstan, Respublika, 420012, Russia
State Autonomous Healthcare Institution Republican Clinical Neurology Centre /ID# 236354
Kazan', Tatarstan, Respublika, 420021, Russia
University Headache Clinic /ID# 236371
Moscow, 119221, Russia
Clinics Chaika /ID# 236394
Moscow, 125047, Russia
Central Clinical Hospital RZHD Medicine /ID# 237024
Moscow, 129128, Russia
Dongtan Sacred Heart Hospital /ID# 238097
Hwaseong, Gyeonggido, 18450, South Korea
Kangbuk Samsung Hospital /ID# 237754
Seoul, Seoul Teugbyeolsi, 03181, South Korea
Yonsei University Health System Severance Hospital /ID# 237839
Seoul, Seoul Teugbyeolsi, 03722, South Korea
Pusan National University Hospital /ID# 237120
Busan, 49241, South Korea
Nowon Eulji Medical Center, Eulji University /ID# 236306
Seoul, 01830, South Korea
Seoul National University Hospital /ID# 237786
Seoul, 03080, South Korea
Samsung Medical Center /ID# 237785
Seoul, 06351, South Korea
Hospital ClĂnico Universitario de Santiago-CHUS /ID# 237623
Santiago de Compostela, A Coruna, 15706, Spain
CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 237645
Pamplona, Navarre, 31008, Spain
Hospital Universitario Vall d'Hebron /ID# 236467
Barcelona, 08035, Spain
Hospital Universitario Virgen del Rocio /ID# 237106
Seville, 41013, Spain
Hospital Clinico Universitario de Valencia /ID# 237400
Valencia, 46010, Spain
Hospital Universitario y Politecnico La Fe /ID# 237087
Valencia, 46026, Spain
Hospital Clinico Universitario de Valladolid /ID# 234406
Valladolid, 47003, Spain
Hospital Clinico Universitario Lozano Blesa /ID# 237373
Zaragoza, 50009, Spain
Stortorgets Neurologmottagning /ID# 236454
Helsingborg, 252 20, Sweden
Kuang-Tien General Hospital /ID# 236309
Taichung, 433, Taiwan
Tainan Sin Lau Hospital /ID# 236358
Tainan, 70142, Taiwan
Chi-Mei Medical Center /ID# 236724
Tainan, 71004, Taiwan
Taipei Veterans General Hosp /ID# 237236
Taipei, 11217, Taiwan
Tri-Service General Hospital /ID# 237657
Taipei, 11490, Taiwan
Walton Centre /ID# 236468
Liverpool, L9 7LJ, United Kingdom
King's College Hospital NHS Foundation Trust /ID# 236301
London, SE5 9RS, United Kingdom
Related Publications (10)
Schlachter L, Stodtmann S, Voelkner A, Jonsson F, Lagraauw HM, Boinpally RR. Population Pharmacokinetics of Atogepant for the Prevention of Migraine. Clin Pharmacokinet. 2025 Nov 12. doi: 10.1007/s40262-025-01566-5. Online ahead of print.
PMID: 41222899DERIVEDUpToDate(R). Nurse Pract. 2023 Jul 1;48(7):16. doi: 10.1097/01.NPR.0000000000000072. No abstract available.
PMID: 40471213DERIVEDGoadsby 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.
PMID: 39982105DERIVEDLipton 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.
PMID: 39715475DERIVEDPeterlin 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.
PMID: 39648629DERIVEDGottschalk 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.
PMID: 39648617DERIVEDGoadsby 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.
PMID: 38924724DERIVEDPozo-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.
PMID: 37516125DERIVEDBoinpally 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.
PMID: 33942560DERIVEDMin 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.
PMID: 33142014DERIVED
Related Links
MeSH Terms
Interventions
Results Point of Contact
- Title
- Global Medical Services
- Organization
- AbbVie
Study Officials
- STUDY DIRECTOR
ALLERGAN INC.
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2019
First Posted
February 26, 2019
Study Start
March 11, 2019
Primary Completion
January 20, 2022
Study Completion
January 20, 2022
Last Updated
February 14, 2023
Results First Posted
February 14, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, 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.
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.