A Long-Term Safety and Tolerability Extension Study Evaluating Atogepant for the Prevention of Chronic or Episodic Migraine

Recruitment Status
COMPLETED
(See Contacts and Locations)Verified November 2025 by AbbVie
Sponsor
AbbVie
Information Provided by (Responsible Party)
AbbVie
Clinicaltrials.gov Identifier
NCT04686136
Other Study ID Numbers:
3101-312-002
First Submitted
December 20, 2020
First Posted
December 27, 2020
Last Update Posted
December 17, 2025
Last Verified
November 2025

ClinicalTrials.gov processed this data on December 2025. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Episodic MigraineChronic Migraine
Drug: Atogepant 60 mg

Study Design

Study TypeInterventional
Actual Enrollment596 participants
Design AllocationN/A
Interventional ModelSingle Group Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleA 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
Study Start DateFebruary 18, 2021
Actual Primary Completion DateOctober 19, 2025
Actual Study Completion DateOctober 19, 2025

Groups and Cohorts

Group/CohortIntervention/Treatment
Atogepant 60 mg
Taken once daily
Drug: Atogepant 60 mg
Tablets containing 60 mg of Atogepant

Outcome Measures

Primary Outcome Measures
  1. Percentage of Participants with at Least 1 Treatment Emergent Adverse Event
Secondary Outcome Measures
  1. Percentage of Participants with Clinically Significant Laboratory Values (Chemistry, Hematology, Urinalysis) as assessed by the Investigator
  2. Percentage of Participants with Clinically Significant Electrocardiograms (ECGs) Findings as assessed by the Investigator
  3. Percentage of Participants with Clinically Significant Vital Sign Measurements as assessed by the Investigator
  4. Columbia-Suicide Severity Rating Scale (C-SSRS) Assessing Suicidal Ideation and Behaviour using 5-Point Scales
    A clinician-rated instrument that reports the severity of both suicidal ideation and behavior. Suicidal ideation is classified on a 5-item scale: 1 (wish to be dead), 2 (nonspecific active suicidal thoughts), 3 (active suicidal ideation with any methods \[not plan\] without intent to act), 4 (active suicidal ideation with some intent to act, without specific plan), and 5 (active suicidal ideation with specific plan and intent). Suicidal behavior is classified on a 5-item scale: 0 (no suicidal behavior), 1 (preparatory acts or behavior), 2 (aborted attempt), 3 (interrupted attempt), and 4 (actual attempt). More than 1 classification can be selected provided they represent separate episodes. (Minimum total score 0, maximum total score 5; higher total scores indicate more suicidal ideation and/or suicidal behavior)

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
\- 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.
Exclusion Criteria
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.
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.

Contacts and Locations

Sponsors and CollaboratorsAbbVie
Locations
Duplicate_Barrow Neurological Institute /ID# 228217 | Phoenix Arizona, United States, 85013-4407California Headache and Balance Center /ID# 226241 | Fresno California, United States, 93720Duplicate_Pharmacology Research Institute (PRI) - Los Alamitos (Wake) /ID# 226404 | Los Alamitos California, United States, 90720-3500Pharmacology Research Institute (PRI) - Newport Beach (Wake) /ID# 226389 | Newport Beach California, United States, 92660Excell Research, Inc /ID# 228390 | Oceanside California, United States, 92056Duplicate_Schuster Medical Research Institute /ID# 226246 | Sherman Oaks California, United States, 91403Alpine Clinical Research Center /ID# 226203 | Boulder Colorado, United States, 80301-1880Sensible Healthcare /ID# 226426 | Ocoee Florida, United States, 34761Accel Research Sites - Tampa Clinical Research Unit /ID# 226252 | Tampa Florida, United States, 33634NeuroTrials Research Inc /ID# 226477 | Atlanta Georgia, United States, 30342Allied Physicians - Fort Wayne Neurological Center /ID# 226390 | Fort Wayne Indiana, United States, 46804Josephson-Wallack-Munshower Neurology - Northeast /ID# 226295 | Indianapolis Indiana, United States, 46256Collective Medical Research /ID# 226482 | Overland Park Kansas, United States, 66210Ochsner Clinic Foundation /ID# 228220 | Covington Louisiana, United States, 70433-8107Pharmasite Research, Inc. /ID# 226444 | Baltimore Maryland, United States, 21208Beth Israel Deaconess Medical Center /ID# 228214 | Boston Massachusetts, United States, 02215-5400BTC of New Bedford /ID# 226289 | New Bedford Massachusetts, United States, 02740Clinical Research Institute, Inc /ID# 226232 | Minneapolis Minnesota, United States, 55402-2606Headache Neurology Research Institute /ID# 226234 | Ridgeland Mississippi, United States, 39157StudyMetrix Research /ID# 226296 | City of Saint Peters Missouri, United States, 63303Clinvest Research LLC /ID# 226275 | Springfield Missouri, United States, 65807Methodist Physicians Clinic/CCT Research /ID# 226422 | Fremont Nebraska, United States, 68025Albuquerque Clinical Trials, Inc. /ID# 226523 | Albuquerque New Mexico, United States, 87102Albany Medical Center Rheumatology /ID# 228212 | Albany New York, United States, 12208-3412Headache Wellness Center /ID# 226233 | Greensboro North Carolina, United States, 27405Duplicate_CTI Clinical Research Center /ID# 226278 | Cincinnati Ohio, United States, 45212Stetson-University of Cincinnati /ID# 226326 | Cincinnati Ohio, United States, 45219Abington Neurological Associates - Abington /ID# 226449 | Abington Pennsylvania, United States, 19001Preferred Primary Care Physicians, Inc. /ID# 226447 | Pittsburgh Pennsylvania, United States, 15236Mount Vernon Clinical Research /ID# 226249 | Chattanooga Tennessee, United States, 37421CNS Healthcare - Memphis /ID# 226254 | Memphis Tennessee, United States, 38119FutureSearch Trials of Neurology /ID# 226424 | Austin Texas, United States, 78731Austin Clinical Trial Partners /ID# 228391 | Austin Texas, United States, 78737DiscoveResearch, Inc /ID# 226490 | Bryan Texas, United States, 77802Texas Neurology /ID# 226425 | Dallas Texas, United States, 75214LinQ Research, LLC /ID# 226391 | Pearland Texas, United States, 77584J. Lewis Research, Inc. / Foothill Family Clinic /ID# 226248 | Salt Lake City Utah, United States, 84109J. Lewis Research, Inc. Foothill Family Clinic South /ID# 226328 | Salt Lake City Utah, United States, 84121Highland Clinical Research /ID# 226287 | Salt Lake City Utah, United States, 84124Sentara Family Medicine Physicians /ID# 226448 | Virginia Beach Virginia, United States, 23456Northwest Clinical Research Center /ID# 226240 | Bellevue Washington, United States, 98007Puget Sound Neurology /ID# 226253 | Tacoma Washington, United States, 25328CHAMP Clinic /ID# 226256 | Calgary Alberta, Canada, T3M 1M4Vancouver Island Health Authority /ID# 226255 | Victoria British Columbia, Canada, V8R 1J8Aggarwal and Associates Limited /ID# 226452 | Brampton Ontario, Canada, L6T 0G1Ottawa Headache Centre Research Inc /ID# 226451 | Ottawa Ontario, Canada, K2G 6E2Diex Recherche Sherbrooke Inc. /ID# 226427 | Sherbrooke Quebec, Canada, J1L 0H8CCR Ostrava, s.r.o. /ID# 228412 | Ostrava Ostrava-mesto, Czechia, 702 00A-Shine s.r.o. /ID# 226207 | Pilsen Plzeň Region, Czechia, 301 00NeuroHK s.r.o. /ID# 226429 | Hradec Králové , Czechia, 500 09BRAIN-SOULTHERAPY s.r.o. /ID# 226394 | Kladno , Czechia, 272 01Pratia Pardubice a.s. /ID# 226393 | Pardubice , Czechia, 530 02Clintrial s.r.o. /ID# 228413 | Prague , Czechia, 100 00DADO MEDICAL s.r.o. /ID# 226421 | Prague , Czechia, 120 00Pratia Prague s.r.o. /ID# 226406 | Prague , Czechia, 130 00Fakultni Thomayerova nemocnice /ID# 228409 | Prague , Czechia, 140 59FORBELI s.r.o. /ID# 228406 | Prague , Czechia, 160 00INEP medical s.r.o. /ID# 228411 | Prague , Czechia, 186 00Vestra Clinics s.r.o. /ID# 226453 | Rychnov nad Kněžnou , Czechia, 516 01NeuroMed Zlin s.r.o. /ID# 228414 | Zlín , Czechia, 760 01Rigshospitalet Glostrup /ID# 228417 | Glostrup Municipality Capital Region, Denmark, 2600CHU Nice - Hopital de Cimiez /ID# 228419 | Nice Alpes-Maritimes, France, 06000AP-HM - Hopital de la Timone /ID# 226407 | Marseille Bouches-du-Rhone, France, 13385Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord /ID# 228418 | St-Priest-en-Jarez Pays de la Loire Region, France, 42270Duplicate_Hôpital Pierre Wertheimer /ID# 226430 | Bron Rhone, France, 69677CHU Clermont Ferrand - Hopital Gabriel Montpied /ID# 226459 | Clermont-Ferrand , France, 63000AP-HP - Groupe Hospitalier 10e - Hopital Lariboisiere /ID# 226220 | Paris , France, 75010Neuropoint GmbH /ID# 226313 | Ulm Baden-Wurttemberg, Germany, 89073Neuropraxis Muenchen Sued /ID# 226309 | Unterhaching Bavaria, Germany, 82008Klinische Forschung Hannover-Mitte GmbH /ID# 226305 | Hanover Lower Saxony, Germany, 30159Studienzentrum Nord-West /ID# 226310 | Westerstede Lower Saxony, Germany, 26655AmBeNet GmbH /ID# 226312 | Leipzig Saxony, Germany, 04107Schmerzklinik Kiel /ID# 226454 | Kiel Schleswig-Holstein, Germany, 24149Zentrum für Neurologie, Neurochirurgie und Psychiatrie /ID# 229991 | Berlin , Germany, 10117Praxis Dr. Gendolla /ID# 229988 | Essen , Germany, 45133Universitaetsklinikum Essen /ID# 229989 | Essen , Germany, 45147Vitos Orthopaedische Klinik Kassel gemeinnuetzige GmbH /ID# 231571 | Kassel , Germany, 34131Velocity Clinical Research /ID# 226307 | Wiesbaden , Germany, 65189Gyongyosi Bugat Pal Korhaz /ID# 228429 | Gyöngyös Heves County, Hungary, 3200Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 226409 | Kaposvár Somogy County, Hungary, 7400Clinexpert Kft /ID# 228431 | Budapest , Hungary, 1033S-Medicon Kft /ID# 228432 | Budapest , Hungary, 1138Azienda Ospedaliero Universitaria Careggi /ID# 228624 | Florence Firenze, Italy, 50134Ospedale Ss. Filippo e Nicola /ID# 228627 | Avezzano L Aquila, Italy, 67051Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 228625 | Milan Milano, Italy, 20133IRCCS San Raffaele /ID# 228436 | Rome Roma, Italy, 00163Universita di Pavia /ID# 228628 | Pavia , Italy, 27100Fondazione Policlinico Universitario Campus Bio-Medico /ID# 228630 | Roma , Italy, 00128Canisius-Wilhelmina Ziekenhuis /ID# 226410 | Nijmegen Gelderland, Netherlands, 6532 SZZorgSaam Zorggroep Zeeuws-Vlaanderen /ID# 226456 | Terneuzen Zeeland, Netherlands, 4535 PASolumed Centrum Medyczne /ID# 226298 | Poznan Greater Poland Voivodeship, Poland, 60-529Vitamed Galaj i Cichomski Sp.j. /ID# 226416 | Bydgoszcz Kuyavian-Pomeranian Voivodeship, Poland, 85-079Specjalistyczne Gabinety Sp. z o.o. /ID# 228631 | Krakow Lesser Poland Voivodeship, Poland, 30-539Centrum Leczenia Padaczki i Migreny /ID# 226458 | Krakow Lesser Poland Voivodeship, Poland, 31-209Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 226412 | Lublin Lublin Voivodeship, Poland, 20-582Centrum Medyczne Pratia Gdynia /ID# 226431 | Gdynia Pomeranian Voivodeship, Poland, 81-338Silmedic Sp. z o.o. /ID# 226457 | Katowice Silesian Voivodeship, Poland, 40-282EuroMedis sp. z o.o. /ID# 226413 | Szczecin West Pomeranian Voivodeship, Poland, 70-111MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak /ID# 226417 | Wroclaw , Poland, 52-210Duplicate_Pusan National University Hospital /ID# 231416 | Busan Busan Gwang Yeogsi, South Korea, 49241Hallym University Dongtan Sacred Heart Hospital /ID# 226264 | Hwaseong Gyeonggido, South Korea, 18450Nowon Eulji Medical Center, Eulji University /ID# 226261 | Seoul Seoul Teugbyeolsi, South Korea, 01830Seoul National University Hospital /ID# 226199 | Seoul Seoul Teugbyeolsi, South Korea, 03080Kangbuk Samsung Hospital /ID# 226263 | Seoul Seoul Teugbyeolsi, South Korea, 03181Samsung Medical Center /ID# 226280 | Seoul Seoul Teugbyeolsi, South Korea, 06351Yonsei University Health System Severance Hospital /ID# 226265 | Seoul , South Korea, 03722Duplicate_CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 226335 | Pamplona Navarre, Spain, 31008Hospital Universitario Vall d'Hebron /ID# 226338 | Barcelona , Spain, 08035Hospital Universitario Virgen del Rocio /ID# 226333 | Seville , Spain, 41013Hospital Clinico Universitario de Valladolid /ID# 226330 | Valladolid , Spain, 47003Kuang-Tien General Hospital /ID# 226259 | Taichung Taichung, Taiwan, 433Tainan Sin Lau Hospital /ID# 226229 | Tainan Tainan, Taiwan, 70142Taipei Veterans General Hospital /ID# 226206 | Taipei City Taipei, Taiwan, 11217Tri-Service General Hospital /ID# 228998 | Taipei , Taiwan, 11490King's College Hospital NHS Foundation Trust /ID# 226524 | London , United Kingdom, SE5 9RSRe:Cognition Health - London /ID# 231205 | London , United Kingdom, W1G 9JF
Investigators
Study Director: ABBVIE INC., AbbVie