Atogepant for Prophylaxis of Migraine in Participants Who Failed Previous Oral Prophylactic Treatments.
NCT ID: NCT04740827
Last Updated: 2023-09-21
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
315 participants
INTERVENTIONAL
2021-03-05
2022-08-04
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy, Safety, and Tolerability of Multiple Dosing Regimens of Oral Atogepant (AGN-241689) in Episodic Migraine Prevention
NCT02848326
Study to Evaluate the Safety and Tolerability of Treatment With Atogepant 60 mg Daily for the Prevention of Migraine in Participants With Episodic Migraine
NCT03700320
Efficacy, Safety, and Tolerability of Atogepant for the Prevention of Chronic Migraine
NCT03855137
12-Week Placebo-controlled Study of Atogepant for the Preventive Treatment of Migraine in Participants With Episodic Migraine
NCT03777059
Study of Oral Atogepant Tablets to Assess Safety and Efficacy in Adult Participants With Migraine
NCT06241313
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo
Participants received atogepant-matching placebo tablets, orally, once daily (QD) for up to 12 weeks in a double-blind (DB) treatment period.
Placebo
Atogepant matching placebo tablets.
Atogepant 60 mg
Participants received atogepant 60 mg, orally, QD for up to 12 weeks in a DB treatment period.
Atogepant 60 mg
Atogepant tablets.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Atogepant 60 mg
Atogepant tablets.
Placebo
Atogepant matching placebo tablets.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Allergan
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
ALLERGAN INC.
Role: STUDY_DIRECTOR
Allergan
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Axiom Research /ID# 226379
Colton, California, United States
Pharmacology Research Institute (PRI) - Encino (Wake) /ID# 226434
Encino, California, United States
Pharmacology Research Institute (PRI) - Los Alamitos (Wake) /ID# 226388
Los Alamitos, California, United States
Pharmacology Research Institute (PRI) - Los Alamitos (Wake) /ID# 226405
Los Alamitos, California, United States
Excell Research, Inc /ID# 228386
Oceanside, California, United States
Alpine Clinical Research Center /ID# 226201
Boulder, Colorado, United States
Sensible Healthcare /ID# 226197
Ocoee, Florida, United States
Meridien Research /ID# 226224
St. Petersburg, Florida, United States
Meridien Research /ID# 226302
St. Petersburg, Florida, United States
Velocity Clinical Research - Boise /ID# 226320
Meridian, Idaho, United States
Allied Physicians - Fort Wayne Neurological Center /ID# 226350
Fort Wayne, Indiana, United States
Deaconess Clinic - Gateway Health Center /ID# 226481
Newburgh, Indiana, United States
Pharmasite Research, Inc. /ID# 226445
Baltimore, Maryland, United States
StudyMetrix Research /ID# 226297
City of Saint Peters, Missouri, United States
Clinvest Research LLC /ID# 226273
Springfield, Missouri, United States
Methodist Physicians Clinic /ID# 226470
Fremont, Nebraska, United States
Amici Clinical Research - Raritan /ID# 226282
Raritan, New Jersey, United States
Albuquerque Clinical Trials, Inc /ID# 233445
Albuquerque, New Mexico, United States
CTI Clinical Trial and Consulting /ID# 226281
Cincinnati, Ohio, United States
FutureSearch Trials of Neurology /ID# 226423
Austin, Texas, United States
Austin Clinical Trial Partners /ID# 228387
Austin, Texas, United States
DiscoveResearch, Inc /ID# 226491
Bryan, Texas, United States
FutureSearch Trials of Dallas, LP /ID# 226493
Dallas, Texas, United States
LinQ Research, LLC /ID# 226227
Pearland, Texas, United States
Highland Clinical Research /ID# 226288
Salt Lake City, Utah, United States
Northwest Clinical Research Center /ID# 226228
Bellevue, Washington, United States
Alfred Health /ID# 226341
Melbourne, Victoria, Australia
The Royal Melbourne Hospital /ID# 226402
Parkville, Victoria, Australia
Aggarwal and Associates Limited /ID# 226321
Brampton, Ontario, Canada
Ottawa Headache Centre Research Inc /ID# 226257
Ottawa, Ontario, Canada
Diex Recherche Sherbrooke Inc. /ID# 226375
Sherbrooke, Quebec, Canada
POLIKLINIKA CHOCEN, a.s. /ID# 226510
Choceň, , Czechia
BRAIN-SOULTHERAPY s.r.o. /ID# 226489
Kladno, , Czechia
CCR Ostrava, s.r.o. /ID# 226279
Ostrava, , Czechia
A-SHINE s.r.o. /ID# 226208
Pilsen, , Czechia
CLINTRIAL s.r.o. /ID# 226192
Prague, , Czechia
DADO MEDICAL s.r.o. /ID# 226548
Prague, , Czechia
CCR Prague s.r.o. /ID# 226214
Prague, , Czechia
CCR Czech a.s /ID# 226270
Prague, , Czechia
FORBELI s.r.o. /ID# 226396
Prague, , Czechia
INEP medical s.r.o. /ID# 226531
Prague, , Czechia
Vestra Clinics s.r.o. /ID# 226547
Rychnov nad Kněžnou, , Czechia
NeuroMed Zlin s.r.o. /ID# 226487
Zlín, , Czechia
Rigshospitalet Glostrup /ID# 226271
Glostrup Municipality, Capital Region, Denmark
CHU Nice - Hopital de Cimiez /ID# 226401
Nice, Alpes-Maritimes, France
CHU Lille /ID# 226501
Lille, Nord, France
CHU de SAINT ETIENNE - Hopital Nord /ID# 226397
Saint Priest EN Jarez, Pays de la Loire Region, France
CHU Clermont Ferand - Hopital Gabriel Montpied /ID# 226438
Clermont-Ferrand, , France
AP-HP - Hopital Lariboisière /ID# 226221
Paris, , France
Universitaetsklinikum Tuebingen /ID# 226529
Tübingen, Baden-Wurttemberg, Germany
Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 226441
Berlin, , Germany
Klinische Forschung Dresden GmbH /ID# 226194
Dresden, , Germany
Praxis Dr. Gendolla /ID# 226497
Essen, , Germany
Universitaetsklinikum Essen /ID# 226527
Essen, , Germany
Klinische Forschung Hannover-Mitte GmbH /ID# 226195
Hanover, , Germany
Universitaetsklinikum Jena Klinik fuer Neurologie /ID# 226439
Jena, , Germany
Vitos Orthopaedische Klinik Kassel gemeinnuetzige GmbH /ID# 231767
Kassel, , Germany
Schmerzklinik Kiel /ID# 226499
Kiel, , Germany
AmBeNet GmbH /ID# 226213
Leipzig, , Germany
Pharmakologisches Studienzentrum Chemnitz GmbH /ID# 226202
Mittweida, , Germany
Universitaetsmedizin Rostock /ID# 226517
Rostock, , Germany
Neuropoint GmbH /ID# 226377
Ulm, , Germany
Neuropraxis Muenchen Sued /ID# 226216
Unterhaching, , Germany
Studienzentrum Nord-West /ID# 226360
Westerstede, , Germany
Intermed GmbH /ID# 226376
Wiesbaden, , Germany
DKD Helios Klinik Wiesbaden /ID# 226534
Wiesbaden, , Germany
Bugat Pal Korhaz /ID# 226357
Gyöngyös, Heves County, Hungary
Valeomed Kft /ID# 226535
Esztergom, Komárom-Esztergom, Hungary
Szent Borbala Korhaz /ID# 226400
Tatabánya, Komárom-Esztergom, Hungary
Somogy Megyei Kaposi Mor Oktato Korhaz /ID# 226485
Kaposvár, Somogy County, Hungary
Mind Klinika Kft. /ID# 233438
Budapest, , Hungary
Clinexpert Kft /ID# 226467
Budapest, , Hungary
Department of Neurology, University of Szeged /ID# 226442
Szeged, , Hungary
Ospedale Ss. Filippo e Nicola /ID# 226530
Avezzano, L Aquila, Italy
Fondazione Policlinico Universitario Campus Bio-Medico di Roma /ID# 226361
Rome, Lazio, Italy
Univ. of Bologna-IRCCS-Istituto delle Scienze Neurologiche /ID# 226475
Bologna, , Italy
Azienda Ospedaliero Universitaria Careggi /ID# 226502
Florence, , Italy
Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 226399
Milan, , Italy
AOU Universita degli Studi della Campania Luigi Vanvitelli /ID# 226503
Napoli, , Italy
Universita di Pavia /ID# 226536
Pavia, , Italy
Martini Ziekenhuis /ID# 226343
Groningen, , Netherlands
Canisius-Wilhelmina Ziekenhuis /ID# 226488
Nijmegen, , Netherlands
ZorgSaam Zorggroep Zeeuws-Vlaanderen /ID# 226317
Terneuzen, , Netherlands
Solumed Centrum Medyczne /ID# 226299
Poznan, Greater Poland Voivodeship, Poland
NZOZ Vitamed /ID# 226293
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Specjalistyczne Gabinety Sp. z o.o. /ID# 226266
Krakow, Lesser Poland Voivodeship, Poland
Centrum Leczenia Padaczki i Migreny /ID# 226543
Krakow, Lesser Poland Voivodeship, Poland
Centrum Medyczne Oporow /ID# 226469
Wroclaw, Lower Silesian Voivodeship, Poland
Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 226235
Lublin, Lublin Voivodeship, Poland
Duplicate_RCMed Oddzial Sochaczew /ID# 226369
Sochaczew, Masovian Voivodeship, Poland
Centrum Medyczne Pratia Gdynia /ID# 226437
Gdynia, Pomeranian Voivodeship, Poland
Silmedic Sp. z o.o. /ID# 226267
Katowice, Silesian Voivodeship, Poland
EuroMedis sp. z o.o. /ID# 226268
Szczecin, West Pomeranian Voivodeship, Poland
Gabinet Lekarski Jacek Rozniecki /ID# 226323
Lodz, Łódź Voivodeship, Poland
Bashkir State Medical University /ID# 226552
Ufa, Bashkortostan Republic, Russia
Kazan State Medical University /ID# 226498
Kazan', Tatarstan, Respublika, Russia
Sbhi Cp 2 Hdm /Id# 226494
Moscow, , Russia
University Headache Clinic /ID# 226435
Moscow, , Russia
Cephalgolog /ID# 226541
Moscow, , Russia
Hospital Unversitario Marques de Valdecilla /ID# 226239
Santander, Cantabria, Spain
University Clinical Hospital of Valladolid /ID# 226528
Valledolid, Castellon, Spain
Hospital Universitario Vall d'Hebron /ID# 226230
Barcelona, , Spain
Hospital Santa Creu i Sant Pau /ID# 226550
Barcelona, , Spain
Hospital Clinico Universitario San Carlos /ID# 226483
Madrid, , Spain
Hospital Clinico Universitario de Valencia /ID# 226472
Valencia, , Spain
Hospital Clinico Universitario Lozano Blesa /ID# 226395
Zaragoza, , Spain
Karolinska university hospital, Huddinge /ID# 226215
Huddinge, Stockholm County, Sweden
Queen Elizabeth University Hospital /ID# 226492
Glasgow, , United Kingdom
Re:Cognition Health - Guildford /ID# 226539
Guildford, , United Kingdom
NHS Highland /ID# 226542
Inverness, , United Kingdom
Leeds Teaching Hospitals NHS Trust /ID# 226538
Leeds, , United Kingdom
St Pancras Clinical Research /ID# 226551
London, , United Kingdom
King's College Hospital NHS Foundation Trust /ID# 226525
London, , United Kingdom
Re:Cognition Health - London /ID# 226540
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
Tassorelli C, Nagy K, Pozo-Rosich P, Lanteri-Minet M, Sacco S, Nezadal T, Guo H, De Abreu Ferreira R, Forero G, Trugman JM. Safety and efficacy of atogepant for the preventive treatment of episodic migraine in adults for whom conventional oral preventive treatments have failed (ELEVATE): a randomised, placebo-controlled, phase 3b trial. Lancet Neurol. 2024 Apr;23(4):382-392. doi: 10.1016/S1474-4422(24)00025-5. Epub 2024 Feb 13.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2019-003448-58
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
3101-304-002
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.