NCT04686136CompletedPhase 3
A Long-Term Safety and Tolerability Extension Study Evaluating Atogepant for the Prevention of Chronic or Episodic Migraine
A Phase 3, Multicenter, Open-Label 156-Week Extension Study To Evaluate The Long-Term Safety And Tolerability Of Oral Atogepant For The Prevention Of Migraine In Participants With Chronic Or Episodic Migraine
Source: ClinicalTrials.gov · Last updated 18 Dec 2025
Brief summary (registry, in English)
This study will evaluate the Long-Term Safety and Tolerability of Atogepant 60 mg daily for the Prevention of Migraine in Participants with Chronic or Episodic Migraine
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 596 (actual)
- First submitted
- 21 Dec 2020
- Start date
- 19 Feb 2021
- Primary completion date
- 20 Oct 2025
- Lead sponsor
- AbbVie
- Diseases
- Migraine
- NCT number
- NCT04686136
- EU CT number
- 2023-507096-21-00
- EudraCT number
- 2020-002470-27
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 596
- From 19 Feb 2021 to the primary completion date, 20 Oct 2025
- 115 sites in 14 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants requiring any medication, diet, or nonpharmacological treatment on the list of prohibited concomitant medications or treatments that cannot be discontinued or switched to an allowable alternative.
Other illness
- Participants with hypertension at Visit 1.
- Participants with clinically significant hematologic, endocrine, cardiovascular, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.
Other
- Participants with an ECG indicating clinically significant abnormalities 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.
Who the study is looking for
- \- Eligible participants who completed Visit 7, and Visit 8 if applicable, of Study 3101-303-002 or Study 3101-304-002 without significant protocol deviations and who did not experience an Adverse Event that may indicate an unacceptable safety risk.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (115)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aggarwal and Associates Limited /ID# 226452 Coordinator of this site? Confirm its status | Brampton | Canada | Unknown status |
| CHAMP Clinic /ID# 226256 Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| Ottawa Headache Centre Research Inc /ID# 226451 Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
| Diex Recherche Sherbrooke Inc. /ID# 226427 Coordinator of this site? Confirm its status | Sherbrooke | Canada | Unknown status |
| Vancouver Island Health Authority /ID# 226255 Coordinator of this site? Confirm its status | Victoria | Canada | Unknown status |
| NEUROHK s r o Coordinator of this site? Confirm its status | Choceň | Czechia | Completed |
| Brain-Soultherapy s.r.o. Coordinator of this site? Confirm its status | Kladno | Czechia | Completed |
| CCR Ostrava s.r.o. Coordinator of this site? Confirm its status | Moravska Ostrava A Privoz | Czechia | Completed |
| Pratia Pardubice a.s. Coordinator of this site? Confirm its status | Pardubice I | Czechia | Completed |
| A-Shine s.r.o. Coordinator of this site? Confirm its status | Plzen 3 | Czechia | Completed |
| INEP medical s.r.o. Coordinator of this site? Confirm its status | Prague | Czechia | Completed |
| DADO MEDICAL s.r.o. Coordinator of this site? Confirm its status | Prague | Czechia | Completed |
| FORBELI s.r.o. Coordinator of this site? Confirm its status | Prague | Czechia | Completed |
| Clintrial s.r.o. Coordinator of this site? Confirm its status | Prague 10 | Czechia | Completed |
| Pratia Prague s.r.o. Coordinator of this site? Confirm its status | Prague 3 | Czechia | Completed |
| Fakultni Thomayerova nemocnice Coordinator of this site? Confirm its status | Prague 4 | Czechia | Completed |
| Vestra Clinics s.r.o. Coordinator of this site? Confirm its status | Rychnov nad Kněžnou | Czechia | Completed |
| NeuroMed Zlin s.r.o. Coordinator of this site? Confirm its status | Zlín | Czechia | Completed |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Completed |
| Praxis Dr. Gendolla Coordinator of this site? Confirm its status | Essen | Germany | Completed |
| Universitaetsklinikum Essen (AoR) Coordinator of this site? Confirm its status | Essen | Germany | Completed |
| Klinische Forschung Hannover-Mitte GmbH Coordinator of this site? Confirm its status | Hanover | Germany | Completed |
| University Hospital Jena KöR Coordinator of this site? Confirm its status | Jena | Germany | Completed |
| Vitos Orthopaedische Klinik Kassel gGmbH Coordinator of this site? Confirm its status | Kassel | Germany | Completed |
| Schmerzklinik Kiel Gmbh & Co. KG Klinik fuer neurologisch-verhaltensmedizinische Schmerztherapie Coordinator of this site? Confirm its status | Kiel | Germany | Completed |
| Ambenet GmbH Das Ambulante Behandlungsnetz Coordinator of this site? Confirm its status | Leipzig | Germany | Completed |
| NeuroPoint Gesellschaft fur vorbeugende Gesundheitspflege GmbH Coordinator of this site? Confirm its status | Ulm | Germany | Completed |
| Neuropraxis Muenchen Sued Coordinator of this site? Confirm its status | Unterhaching | Germany | Completed |
| Dr. med. Joachim Springub Facharzt fuer Neurologie u. Psychiatrie Zusatzbezeichnung Psychotherapie Wolfgang Schwarz Facharzt fuer Neurologie Zusatzbezeichnung Psychotherapie Partnerschaft Coordinator of this site? Confirm its status | Westerstede | Germany | Completed |
| Intermed Institut fuer medizinische Forschung und Arzneimittelsicherheit GmbH Coordinator of this site? Confirm its status | Wiesbaden | Germany | Completed |
| Rigshospitalet Coordinator of this site? Confirm its status | Glostrup | Denmark | Completed |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Completed |
| Hospital Clínico Universitario de Valladolid Coordinator of this site? Confirm its status | Valladolid | Spain | Completed |
| Chu Gabriel Montpied Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Completed |
| Assistance Publique Hôpitaux de Marseille Coordinator of this site? Confirm its status | Marseille | France | Completed |
| Centre Hospitalier Universitaire de Nice Coordinator of this site? Confirm its status | Nice | France | Completed |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Paris Cedex 10 | France | Completed |
| Centre Hospitalier Universitaire de Saint Etienne Coordinator of this site? Confirm its status | Saint-Priest-en-Jarez | France | Completed |
| Re:Cognition Health - London /ID# 231205 Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| King's College Hospital NHS Foundation Trust /ID# 226524 Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Clinexpert Kft. Coordinator of this site? Confirm its status | Budapest III | Hungary | Completed |
| S-Medicon Kft. Coordinator of this site? Confirm its status | Budapest XIII | Hungary | Completed |
| Gyöngyösi Bugát Pál Kórház Coordinator of this site? Confirm its status | Gyongyos | Hungary | Completed |
| Somogy Vármegyei Kaposi Mór Oktató Kórház Coordinator of this site? Confirm its status | Kaposvár | Hungary | Completed |
| Careggi University Hospital Coordinator of this site? Confirm its status | Florence | Italy | Completed |
| Azienda Sanitaria Locale Avezzano Sulmona L'Aquila Coordinator of this site? Confirm its status | L'aquila | Italy | Completed |
| IRCCS Foundation Istituto Neurologico Carlo Besta Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| Neurological Institute Foundation Casimiro Mondino Coordinator of this site? Confirm its status | Pavia | Italy | Completed |
| Irccs San Raffaele Roma S.r.l. Coordinator of this site? Confirm its status | Rome | Italy | Completed |
| Fondazione Policlinico Universitario Campus Bio-Medico Coordinator of this site? Confirm its status | Rome | Italy | Completed |
| Duplicate_Pusan National University Hospital /ID# 231416 Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
| Hallym University Dongtan Sacred Heart Hospital /ID# 226264 Coordinator of this site? Confirm its status | Hwaseong | South Korea | Unknown status |
| Yonsei University Health System Severance Hospital /ID# 226265 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Nowon Eulji Medical Center, Eulji University /ID# 226261 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Samsung Medical Center /ID# 226280 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Seoul National University Hospital /ID# 226199 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Kangbuk Samsung Hospital /ID# 226263 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Canisius-Wilhelmina Hospital Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Completed |
| ZorgSaam Ziekenhuis Coordinator of this site? Confirm its status | Terneuzen | Netherlands | Completed |
| Vitamed Galaj i Cichomski sp.j. Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Completed |
| Specjalistyczne Gabinety Sp. z o.o. Coordinator of this site? Confirm its status | Cracow | Poland | Completed |
| Centrum Leczenia Padaczki I Migreny S.A. Coordinator of this site? Confirm its status | Cracow | Poland | Completed |
| Pratia S.A. Coordinator of this site? Confirm its status | Gdynia | Poland | Completed |
| Silmedic Sp. z o.o. Coordinator of this site? Confirm its status | Katowice | Poland | Completed |
| Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej Coordinator of this site? Confirm its status | Lublin | Poland | Completed |
| Solumed Sp. z o.o. sp.k. Coordinator of this site? Confirm its status | Poznan | Poland | Completed |
| EUROMEDIS Sp z o o Coordinator of this site? Confirm its status | Szczecin | Poland | Completed |
| MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak Coordinator of this site? Confirm its status | Wrocław | Poland | Completed |
| Kuang-Tien General Hospital /ID# 226259 Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| Tainan Sin Lau Hospital /ID# 226229 Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| Tri-Service General Hospital /ID# 228998 Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Taipei Veterans General Hospital /ID# 226206 Coordinator of this site? Confirm its status | Taipei City | Taiwan | Unknown status |
| Abington Neurological Associates - Abington /ID# 226449 Coordinator of this site? Confirm its status | Abington | United States | Unknown status |
| Albany Medical Center Rheumatology /ID# 228212 Coordinator of this site? Confirm its status | Albany | United States | Unknown status |
| Albuquerque Clinical Trials, Inc. /ID# 226523 Coordinator of this site? Confirm its status | Albuquerque | United States | Unknown status |
| NeuroTrials Research Inc /ID# 226477 Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| FutureSearch Trials of Neurology /ID# 226424 Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Austin Clinical Trial Partners /ID# 228391 Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Pharmasite Research, Inc. /ID# 226444 Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Northwest Clinical Research Center /ID# 226240 Coordinator of this site? Confirm its status | Bellevue | United States | Unknown status |
| Beth Israel Deaconess Medical Center /ID# 228214 Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Alpine Clinical Research Center /ID# 226203 Coordinator of this site? Confirm its status | Boulder | United States | Unknown status |
| DiscoveResearch, Inc /ID# 226490 Coordinator of this site? Confirm its status | Bryan | United States | Unknown status |
| Mount Vernon Clinical Research /ID# 226249 Coordinator of this site? Confirm its status | Chattanooga | United States | Unknown status |
| Duplicate_CTI Clinical Research Center /ID# 226278 Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Stetson-University of Cincinnati /ID# 226326 Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| StudyMetrix Research /ID# 226296 Coordinator of this site? Confirm its status | City of Saint Peters | United States | Unknown status |
| Ochsner Clinic Foundation /ID# 228220 Coordinator of this site? Confirm its status | Covington | United States | Unknown status |
| Texas Neurology /ID# 226425 Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Allied Physicians - Fort Wayne Neurological Center /ID# 226390 Coordinator of this site? Confirm its status | Fort Wayne | United States | Unknown status |
| Methodist Physicians Clinic/CCT Research /ID# 226422 Coordinator of this site? Confirm its status | Fremont | United States | Unknown status |
| California Headache and Balance Center /ID# 226241 Coordinator of this site? Confirm its status | Fresno | United States | Unknown status |
| Headache Wellness Center /ID# 226233 Coordinator of this site? Confirm its status | Greensboro | United States | Unknown status |
| Josephson-Wallack-Munshower Neurology - Northeast /ID# 226295 Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| Duplicate_Pharmacology Research Institute (PRI) - Los Alamitos (Wake) /ID# 226404 Coordinator of this site? Confirm its status | Los Alamitos | United States | Unknown status |
| CNS Healthcare - Memphis /ID# 226254 Coordinator of this site? Confirm its status | Memphis | United States | Unknown status |
| Clinical Research Institute, Inc /ID# 226232 Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| BTC of New Bedford /ID# 226289 Coordinator of this site? Confirm its status | New Bedford | United States | Unknown status |
| Pharmacology Research Institute (PRI) - Newport Beach (Wake) /ID# 226389 Coordinator of this site? Confirm its status | Newport Beach | United States | Unknown status |
| Excell Research, Inc /ID# 228390 Coordinator of this site? Confirm its status | Oceanside | United States | Unknown status |
| Sensible Healthcare /ID# 226426 Coordinator of this site? Confirm its status | Ocoee | United States | Unknown status |
| Collective Medical Research /ID# 226482 Coordinator of this site? Confirm its status | Overland Park | United States | Unknown status |
| LinQ Research, LLC /ID# 226391 Coordinator of this site? Confirm its status | Pearland | United States | Unknown status |
| Duplicate_Barrow Neurological Institute /ID# 228217 Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Preferred Primary Care Physicians, Inc. /ID# 226447 Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Headache Neurology Research Institute /ID# 226234 Coordinator of this site? Confirm its status | Ridgeland | United States | Unknown status |
| J. Lewis Research, Inc. / Foothill Family Clinic /ID# 226248 Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| Highland Clinical Research /ID# 226287 Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| J. Lewis Research, Inc. Foothill Family Clinic South /ID# 226328 Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| Duplicate_Schuster Medical Research Institute /ID# 226246 Coordinator of this site? Confirm its status | Sherman Oaks | United States | Unknown status |
| Clinvest Research LLC /ID# 226275 Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| Puget Sound Neurology /ID# 226253 Coordinator of this site? Confirm its status | Tacoma | United States | Unknown status |
| Accel Research Sites - Tampa Clinical Research Unit /ID# 226252 Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Sentara Family Medicine Physicians /ID# 226448 Coordinator of this site? Confirm its status | Virginia Beach | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.