A Long-Term Safety and Tolerability Extension Study Evaluating Atogepant for the Prevention of Chronic or Episodic Migraine
NCT ID: NCT04686136
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
596 participants
INTERVENTIONAL
2021-02-19
2025-10-20
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Atogepant 60 mg
Taken once daily
Atogepant 60 mg
Tablets containing 60 mg of Atogepant
Interventions
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Atogepant 60 mg
Tablets containing 60 mg of Atogepant
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Participants with an ECG indicating clinically significant abnormalities at Visit 1.
* Participants with hypertension at Visit 1.
* Participants with a significant risk of self-harm, or of harm to others; participants who report suicidal ideation with intent, with or without a plan, since the last visit, must be excluded.
* Participants with clinically significant hematologic, endocrine, cardiovascular, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.
18 Years
80 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Duplicate_Barrow Neurological Institute /ID# 228217
Phoenix, Arizona, United States
California Headache and Balance Center /ID# 226241
Fresno, California, United States
Duplicate_Pharmacology Research Institute (PRI) - Los Alamitos (Wake) /ID# 226404
Los Alamitos, California, United States
Pharmacology Research Institute (PRI) - Newport Beach (Wake) /ID# 226389
Newport Beach, California, United States
Excell Research, Inc /ID# 228390
Oceanside, California, United States
Duplicate_Schuster Medical Research Institute /ID# 226246
Sherman Oaks, California, United States
Alpine Clinical Research Center /ID# 226203
Boulder, Colorado, United States
Sensible Healthcare /ID# 226426
Ocoee, Florida, United States
Accel Research Sites - Tampa Clinical Research Unit /ID# 226252
Tampa, Florida, United States
NeuroTrials Research Inc /ID# 226477
Atlanta, Georgia, United States
Allied Physicians - Fort Wayne Neurological Center /ID# 226390
Fort Wayne, Indiana, United States
Josephson-Wallack-Munshower Neurology - Northeast /ID# 226295
Indianapolis, Indiana, United States
Collective Medical Research /ID# 226482
Overland Park, Kansas, United States
Ochsner Clinic Foundation /ID# 228220
Covington, Louisiana, United States
Pharmasite Research, Inc. /ID# 226444
Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center /ID# 228214
Boston, Massachusetts, United States
BTC of New Bedford /ID# 226289
New Bedford, Massachusetts, United States
Clinical Research Institute, Inc /ID# 226232
Minneapolis, Minnesota, United States
Headache Neurology Research Institute /ID# 226234
Ridgeland, Mississippi, United States
StudyMetrix Research /ID# 226296
City of Saint Peters, Missouri, United States
Clinvest Research LLC /ID# 226275
Springfield, Missouri, United States
Methodist Physicians Clinic/CCT Research /ID# 226422
Fremont, Nebraska, United States
Albuquerque Clinical Trials, Inc. /ID# 226523
Albuquerque, New Mexico, United States
Albany Medical Center Rheumatology /ID# 228212
Albany, New York, United States
Headache Wellness Center /ID# 226233
Greensboro, North Carolina, United States
Duplicate_CTI Clinical Research Center /ID# 226278
Cincinnati, Ohio, United States
Stetson-University of Cincinnati /ID# 226326
Cincinnati, Ohio, United States
Abington Neurological Associates - Abington /ID# 226449
Abington, Pennsylvania, United States
Preferred Primary Care Physicians, Inc. /ID# 226447
Pittsburgh, Pennsylvania, United States
Mount Vernon Clinical Research /ID# 226249
Chattanooga, Tennessee, United States
CNS Healthcare - Memphis /ID# 226254
Memphis, Tennessee, United States
FutureSearch Trials of Neurology /ID# 226424
Austin, Texas, United States
Austin Clinical Trial Partners /ID# 228391
Austin, Texas, United States
DiscoveResearch, Inc /ID# 226490
Bryan, Texas, United States
Texas Neurology /ID# 226425
Dallas, Texas, United States
LinQ Research, LLC /ID# 226391
Pearland, Texas, United States
J. Lewis Research, Inc. / Foothill Family Clinic /ID# 226248
Salt Lake City, Utah, United States
J. Lewis Research, Inc. Foothill Family Clinic South /ID# 226328
Salt Lake City, Utah, United States
Highland Clinical Research /ID# 226287
Salt Lake City, Utah, United States
Sentara Family Medicine Physicians /ID# 226448
Virginia Beach, Virginia, United States
Northwest Clinical Research Center /ID# 226240
Bellevue, Washington, United States
Puget Sound Neurology /ID# 226253
Tacoma, Washington, United States
CHAMP Clinic /ID# 226256
Calgary, Alberta, Canada
Vancouver Island Health Authority /ID# 226255
Victoria, British Columbia, Canada
Aggarwal and Associates Limited /ID# 226452
Brampton, Ontario, Canada
Ottawa Headache Centre Research Inc /ID# 226451
Ottawa, Ontario, Canada
Diex Recherche Sherbrooke Inc. /ID# 226427
Sherbrooke, Quebec, Canada
CCR Ostrava, s.r.o. /ID# 228412
Ostrava, Ostrava-mesto, Czechia
A-Shine s.r.o. /ID# 226207
Pilsen, Plzeň Region, Czechia
NeuroHK s.r.o. /ID# 226429
Hradec Králové, , Czechia
BRAIN-SOULTHERAPY s.r.o. /ID# 226394
Kladno, , Czechia
Pratia Pardubice a.s. /ID# 226393
Pardubice, , Czechia
Clintrial s.r.o. /ID# 228413
Prague, , Czechia
DADO MEDICAL s.r.o. /ID# 226421
Prague, , Czechia
Pratia Prague s.r.o. /ID# 226406
Prague, , Czechia
Fakultni Thomayerova nemocnice /ID# 228409
Prague, , Czechia
FORBELI s.r.o. /ID# 228406
Prague, , Czechia
INEP medical s.r.o. /ID# 228411
Prague, , Czechia
Vestra Clinics s.r.o. /ID# 226453
Rychnov nad Kněžnou, , Czechia
NeuroMed Zlin s.r.o. /ID# 228414
Zlín, , Czechia
Rigshospitalet Glostrup /ID# 228417
Glostrup Municipality, Capital Region, Denmark
CHU Nice - Hopital de Cimiez /ID# 228419
Nice, Alpes-Maritimes, France
AP-HM - Hopital de la Timone /ID# 226407
Marseille, Bouches-du-Rhone, France
Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord /ID# 228418
St-Priest-en-Jarez, Pays de la Loire Region, France
Duplicate_Hôpital Pierre Wertheimer /ID# 226430
Bron, Rhone, France
CHU Clermont Ferrand - Hopital Gabriel Montpied /ID# 226459
Clermont-Ferrand, , France
AP-HP - Groupe Hospitalier 10e - Hopital Lariboisiere /ID# 226220
Paris, , France
Neuropoint GmbH /ID# 226313
Ulm, Baden-Wurttemberg, Germany
Neuropraxis Muenchen Sued /ID# 226309
Unterhaching, Bavaria, Germany
Klinische Forschung Hannover-Mitte GmbH /ID# 226305
Hanover, Lower Saxony, Germany
Studienzentrum Nord-West /ID# 226310
Westerstede, Lower Saxony, Germany
AmBeNet GmbH /ID# 226312
Leipzig, Saxony, Germany
Schmerzklinik Kiel /ID# 226454
Kiel, Schleswig-Holstein, Germany
Zentrum für Neurologie, Neurochirurgie und Psychiatrie /ID# 229991
Berlin, , Germany
Praxis Dr. Gendolla /ID# 229988
Essen, , Germany
Universitaetsklinikum Essen /ID# 229989
Essen, , Germany
Vitos Orthopaedische Klinik Kassel gemeinnuetzige GmbH /ID# 231571
Kassel, , Germany
Velocity Clinical Research /ID# 226307
Wiesbaden, , Germany
Gyongyosi Bugat Pal Korhaz /ID# 228429
Gyöngyös, Heves County, Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 226409
Kaposvár, Somogy County, Hungary
Clinexpert Kft /ID# 228431
Budapest, , Hungary
S-Medicon Kft /ID# 228432
Budapest, , Hungary
Azienda Ospedaliero Universitaria Careggi /ID# 228624
Florence, Firenze, Italy
Ospedale Ss. Filippo e Nicola /ID# 228627
Avezzano, L Aquila, Italy
Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 228625
Milan, Milano, Italy
IRCCS San Raffaele /ID# 228436
Rome, Roma, Italy
Universita di Pavia /ID# 228628
Pavia, , Italy
Fondazione Policlinico Universitario Campus Bio-Medico /ID# 228630
Roma, , Italy
Canisius-Wilhelmina Ziekenhuis /ID# 226410
Nijmegen, Gelderland, Netherlands
ZorgSaam Zorggroep Zeeuws-Vlaanderen /ID# 226456
Terneuzen, Zeeland, Netherlands
Solumed Centrum Medyczne /ID# 226298
Poznan, Greater Poland Voivodeship, Poland
Vitamed Galaj i Cichomski Sp.j. /ID# 226416
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Specjalistyczne Gabinety Sp. z o.o. /ID# 228631
Krakow, Lesser Poland Voivodeship, Poland
Centrum Leczenia Padaczki i Migreny /ID# 226458
Krakow, Lesser Poland Voivodeship, Poland
Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 226412
Lublin, Lublin Voivodeship, Poland
Centrum Medyczne Pratia Gdynia /ID# 226431
Gdynia, Pomeranian Voivodeship, Poland
Silmedic Sp. z o.o. /ID# 226457
Katowice, Silesian Voivodeship, Poland
EuroMedis sp. z o.o. /ID# 226413
Szczecin, West Pomeranian Voivodeship, Poland
MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak /ID# 226417
Wroclaw, , Poland
Duplicate_Pusan National University Hospital /ID# 231416
Busan, Busan Gwang Yeogsi, South Korea
Hallym University Dongtan Sacred Heart Hospital /ID# 226264
Hwaseong, Gyeonggido, South Korea
Nowon Eulji Medical Center, Eulji University /ID# 226261
Seoul, Seoul Teugbyeolsi, South Korea
Seoul National University Hospital /ID# 226199
Seoul, Seoul Teugbyeolsi, South Korea
Kangbuk Samsung Hospital /ID# 226263
Seoul, Seoul Teugbyeolsi, South Korea
Samsung Medical Center /ID# 226280
Seoul, Seoul Teugbyeolsi, South Korea
Yonsei University Health System Severance Hospital /ID# 226265
Seoul, , South Korea
Duplicate_CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 226335
Pamplona, Navarre, Spain
Hospital Universitario Vall d'Hebron /ID# 226338
Barcelona, , Spain
Hospital Universitario Virgen del Rocio /ID# 226333
Seville, , Spain
Hospital Clinico Universitario de Valladolid /ID# 226330
Valladolid, , Spain
Kuang-Tien General Hospital /ID# 226259
Taichung, Taichung, Taiwan
Tainan Sin Lau Hospital /ID# 226229
Tainan, Tainan, Taiwan
Taipei Veterans General Hospital /ID# 226206
Taipei City, Taipei, Taiwan
Tri-Service General Hospital /ID# 228998
Taipei, , Taiwan
King's College Hospital NHS Foundation Trust /ID# 226524
London, , United Kingdom
Re:Cognition Health - London /ID# 231205
London, , United Kingdom
Countries
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References
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Ashina S, Ashina M, Holle-Lee D, Tassorelli C, Cho SJ, He MY, De Abreu Ferreira R, Gandhi P, Smith JH, Pfleeger K, Trugman JM. Long-term safety, efficacy and functional outcomes of atogepant for the preventive treatment of migraine. Cephalalgia. 2025 Aug;45(8):3331024251365206. doi: 10.1177/03331024251365206. Epub 2025 Aug 19.
Related Links
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Other Identifiers
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2020-002470-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
3101-312-002
Identifier Type: -
Identifier Source: org_study_id