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

December 16, 2025 updated by: AbbVie

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

596

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3M 1M4
        • CHAMP Clinic /ID# 226256
    • British Columbia
      • Victoria, British Columbia, Canada, V8R 1J8
        • Vancouver Island Health Authority /ID# 226255
    • Ontario
      • Brampton, Ontario, Canada, L6T 0G1
        • Aggarwal and Associates Limited /ID# 226452
      • Ottawa, Ontario, Canada, K2G 6E2
        • Ottawa Headache Centre Research Inc /ID# 226451
    • Quebec
      • Sherbrooke, Quebec, Canada, J1L 0H8
        • Diex Recherche Sherbrooke Inc. /ID# 226427
  • Czechia
      • Hradec Králové, Czechia, 500 09
        • NeuroHK s.r.o. /ID# 226429
      • Kladno, Czechia, 272 01
        • BRAIN-SOULTHERAPY s.r.o. /ID# 226394
      • Pardubice, Czechia, 530 02
        • Pratia Pardubice a.s. /ID# 226393
      • Prague, Czechia, 160 00
        • FORBELI s.r.o. /ID# 228406
      • Prague, Czechia, 130 00
        • Pratia Prague s.r.o. /ID# 226406
      • Prague, Czechia, 100 00
        • Clintrial s.r.o. /ID# 228413
      • Prague, Czechia, 120 00
        • DADO MEDICAL s.r.o. /ID# 226421
      • Prague, Czechia, 140 59
        • Fakultni Thomayerova nemocnice /ID# 228409
      • Prague, Czechia, 186 00
        • INEP medical s.r.o. /ID# 228411
      • Rychnov nad Kněžnou, Czechia, 516 01
        • Vestra Clinics s.r.o. /ID# 226453
      • Zlín, Czechia, 760 01
        • NeuroMed Zlin s.r.o. /ID# 228414
    • Ostrava-mesto
      • Ostrava, Ostrava-mesto, Czechia, 702 00
        • CCR Ostrava, s.r.o. /ID# 228412
    • Plzeň Region
      • Pilsen, Plzeň Region, Czechia, 301 00
        • A-Shine s.r.o. /ID# 226207
  • Denmark
    • Capital Region
      • Glostrup Municipality, Capital Region, Denmark, 2600
        • Rigshospitalet Glostrup /ID# 228417
  • France
      • Clermont-Ferrand, France, 63000
        • CHU Clermont Ferrand - Hopital Gabriel Montpied /ID# 226459
      • Paris, France, 75010
        • AP-HP - Groupe Hospitalier 10e - Hopital Lariboisiere /ID# 226220
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, France, 06000
        • CHU Nice - Hopital de Cimiez /ID# 228419
    • Bouches-du-Rhone
      • Marseille, Bouches-du-Rhone, France, 13385
        • AP-HM - Hopital de la Timone /ID# 226407
    • Pays de la Loire Region
      • St-Priest-en-Jarez, Pays de la Loire Region, France, 42270
        • Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord /ID# 228418
    • Rhone
      • Bron, Rhone, France, 69677
        • Duplicate_Hôpital Pierre Wertheimer /ID# 226430
  • Germany
      • Berlin, Germany, 10117
        • Zentrum für Neurologie, Neurochirurgie und Psychiatrie /ID# 229991
      • Essen, Germany, 45133
        • Praxis Dr. Gendolla /ID# 229988
      • Essen, Germany, 45147
        • Universitaetsklinikum Essen /ID# 229989
      • Kassel, Germany, 34131
        • Vitos Orthopaedische Klinik Kassel gemeinnuetzige GmbH /ID# 231571
      • Wiesbaden, Germany, 65189
        • Velocity Clinical Research /ID# 226307
    • Baden-Wurttemberg
      • Ulm, Baden-Wurttemberg, Germany, 89073
        • Neuropoint GmbH /ID# 226313
    • Bavaria
      • Unterhaching, Bavaria, Germany, 82008
        • Neuropraxis Muenchen Sued /ID# 226309
    • Lower Saxony
      • Hanover, Lower Saxony, Germany, 30159
        • Klinische Forschung Hannover-Mitte GmbH /ID# 226305
      • Westerstede, Lower Saxony, Germany, 26655
        • Studienzentrum Nord-West /ID# 226310
    • Saxony
      • Leipzig, Saxony, Germany, 04107
        • AmBeNet GmbH /ID# 226312
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24149
        • Schmerzklinik Kiel /ID# 226454
  • Hungary
      • Budapest, Hungary, 1033
        • Clinexpert Kft /ID# 228431
      • Budapest, Hungary, 1138
        • S-Medicon Kft /ID# 228432
    • Heves County
      • Gyöngyös, Heves County, Hungary, 3200
        • Gyongyosi Bugat Pal Korhaz /ID# 228429
    • Somogy County
      • Kaposvár, Somogy County, Hungary, 7400
        • Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 226409
  • Italy
      • Pavia, Italy, 27100
        • Universita di Pavia /ID# 228628
      • Roma, Italy, 00128
        • Fondazione Policlinico Universitario Campus Bio-Medico /ID# 228630
    • Firenze
      • Florence, Firenze, Italy, 50134
        • Azienda Ospedaliero Universitaria Careggi /ID# 228624
    • L Aquila
      • Avezzano, L Aquila, Italy, 67051
        • Ospedale Ss. Filippo e Nicola /ID# 228627
    • Milano
      • Milan, Milano, Italy, 20133
        • Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 228625
    • Roma
      • Rome, Roma, Italy, 00163
        • IRCCS San Raffaele /ID# 228436
  • Netherlands
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6532 SZ
        • Canisius-Wilhelmina Ziekenhuis /ID# 226410
    • Zeeland
      • Terneuzen, Zeeland, Netherlands, 4535 PA
        • ZorgSaam Zorggroep Zeeuws-Vlaanderen /ID# 226456
  • Poland
      • Wroclaw, Poland, 52-210
        • MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak /ID# 226417
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Poland, 60-529
        • Solumed Centrum Medyczne /ID# 226298
    • Kuyavian-Pomeranian Voivodeship
      • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-079
        • Vitamed Galaj i Cichomski Sp.j. /ID# 226416
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Poland, 30-539
        • Specjalistyczne Gabinety Sp. z o.o. /ID# 228631
      • Krakow, Lesser Poland Voivodeship, Poland, 31-209
        • Centrum Leczenia Padaczki i Migreny /ID# 226458
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Poland, 20-582
        • Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 226412
    • Pomeranian Voivodeship
      • Gdynia, Pomeranian Voivodeship, Poland, 81-338
        • Centrum Medyczne Pratia Gdynia /ID# 226431
    • Silesian Voivodeship
      • Katowice, Silesian Voivodeship, Poland, 40-282
        • Silmedic Sp. z o.o. /ID# 226457
    • West Pomeranian Voivodeship
      • Szczecin, West Pomeranian Voivodeship, Poland, 70-111
        • EuroMedis sp. z o.o. /ID# 226413
  • South Korea
      • Seoul, South Korea, 03722
        • Yonsei University Health System Severance Hospital /ID# 226265
    • Busan Gwang Yeogsi
      • Busan, Busan Gwang Yeogsi, South Korea, 49241
        • Duplicate_Pusan National University Hospital /ID# 231416
    • Gyeonggido
      • Hwaseong, Gyeonggido, South Korea, 18450
        • Hallym University Dongtan Sacred Heart Hospital /ID# 226264
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, South Korea, 01830
        • Nowon Eulji Medical Center, Eulji University /ID# 226261
      • Seoul, Seoul Teugbyeolsi, South Korea, 03080
        • Seoul National University Hospital /ID# 226199
      • Seoul, Seoul Teugbyeolsi, South Korea, 03181
        • Kangbuk Samsung Hospital /ID# 226263
      • Seoul, Seoul Teugbyeolsi, South Korea, 06351
        • Samsung Medical Center /ID# 226280
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitario Vall d'Hebron /ID# 226338
      • Seville, Spain, 41013
        • Hospital Universitario Virgen del Rocio /ID# 226333
      • Valladolid, Spain, 47003
        • Hospital Clinico Universitario de Valladolid /ID# 226330
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Duplicate_CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 226335
  • Taiwan
      • Taipei, Taiwan, 11490
        • Tri-Service General Hospital /ID# 228998
    • Taichung
      • Taichung, Taichung, Taiwan, 433
        • Kuang-Tien General Hospital /ID# 226259
    • Tainan
      • Tainan, Tainan, Taiwan, 70142
        • Tainan Sin Lau Hospital /ID# 226229
    • Taipei
      • Taipei City, Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital /ID# 226206
  • United Kingdom
      • London, United Kingdom, SE5 9RS
        • King's College Hospital NHS Foundation Trust /ID# 226524
      • London, United Kingdom, W1G 9JF
        • Re:Cognition Health - London /ID# 231205
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013-4407
        • Duplicate_Barrow Neurological Institute /ID# 228217
    • California
      • Fresno, California, United States, 93720
        • California Headache and Balance Center /ID# 226241
      • Los Alamitos, California, United States, 90720-3500
        • Duplicate_Pharmacology Research Institute (PRI) - Los Alamitos (Wake) /ID# 226404
      • Newport Beach, California, United States, 92660
        • Pharmacology Research Institute (PRI) - Newport Beach (Wake) /ID# 226389
      • Oceanside, California, United States, 92056
        • Excell Research, Inc /ID# 228390
      • Sherman Oaks, California, United States, 91403
        • Duplicate_Schuster Medical Research Institute /ID# 226246
    • Colorado
      • Boulder, Colorado, United States, 80301-1880
        • Alpine Clinical Research Center /ID# 226203
    • Florida
      • Ocoee, Florida, United States, 34761
        • Sensible Healthcare /ID# 226426
      • Tampa, Florida, United States, 33634
        • Accel Research Sites - Tampa Clinical Research Unit /ID# 226252
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • NeuroTrials Research Inc /ID# 226477
    • Indiana
      • Fort Wayne, Indiana, United States, 46804
        • Allied Physicians - Fort Wayne Neurological Center /ID# 226390
      • Indianapolis, Indiana, United States, 46256
        • Josephson-Wallack-Munshower Neurology - Northeast /ID# 226295
    • Kansas
      • Overland Park, Kansas, United States, 66210
        • Collective Medical Research /ID# 226482
    • Louisiana
      • Covington, Louisiana, United States, 70433-8107
        • Ochsner Clinic Foundation /ID# 228220
    • Maryland
      • Baltimore, Maryland, United States, 21208
        • Pharmasite Research, Inc. /ID# 226444
    • Massachusetts
      • Boston, Massachusetts, United States, 02215-5400
        • Beth Israel Deaconess Medical Center /ID# 228214
      • New Bedford, Massachusetts, United States, 02740
        • BTC of New Bedford /ID# 226289
    • Minnesota
      • Minneapolis, Minnesota, United States, 55402-2606
        • Clinical Research Institute, Inc /ID# 226232
    • Mississippi
      • Ridgeland, Mississippi, United States, 39157
        • Headache Neurology Research Institute /ID# 226234
    • Missouri
      • City of Saint Peters, Missouri, United States, 63303
        • StudyMetrix Research /ID# 226296
      • Springfield, Missouri, United States, 65807
        • Clinvest Research LLC /ID# 226275
    • Nebraska
      • Fremont, Nebraska, United States, 68025
        • Methodist Physicians Clinic/CCT Research /ID# 226422
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Albuquerque Clinical Trials, Inc. /ID# 226523
    • New York
      • Albany, New York, United States, 12208-3412
        • Albany Medical Center Rheumatology /ID# 228212
    • North Carolina
      • Greensboro, North Carolina, United States, 27405
        • Headache Wellness Center /ID# 226233
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Stetson-University of Cincinnati /ID# 226326
      • Cincinnati, Ohio, United States, 45212
        • Duplicate_CTI Clinical Research Center /ID# 226278
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
        • Abington Neurological Associates - Abington /ID# 226449
      • Pittsburgh, Pennsylvania, United States, 15236
        • Preferred Primary Care Physicians, Inc. /ID# 226447
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • Mount Vernon Clinical Research /ID# 226249
      • Memphis, Tennessee, United States, 38119
        • CNS Healthcare - Memphis /ID# 226254
    • Texas
      • Austin, Texas, United States, 78731
        • FutureSearch Trials of Neurology /ID# 226424
      • Austin, Texas, United States, 78737
        • Austin Clinical Trial Partners /ID# 228391
      • Bryan, Texas, United States, 77802
        • DiscoveResearch, Inc /ID# 226490
      • Dallas, Texas, United States, 75214
        • Texas Neurology /ID# 226425
      • Pearland, Texas, United States, 77584
        • LinQ Research, LLC /ID# 226391
    • Utah
      • Salt Lake City, Utah, United States, 84109
        • J. Lewis Research, Inc. / Foothill Family Clinic /ID# 226248
      • Salt Lake City, Utah, United States, 84121
        • J. Lewis Research, Inc. Foothill Family Clinic South /ID# 226328
      • Salt Lake City, Utah, United States, 84124
        • Highland Clinical Research /ID# 226287
    • Virginia
      • Virginia Beach, Virginia, United States, 23456
        • Sentara Family Medicine Physicians /ID# 226448
    • Washington
      • Bellevue, Washington, United States, 98007
        • Northwest Clinical Research Center /ID# 226240
      • Tacoma, Washington, United States, 25328
        • Puget Sound Neurology /ID# 226253

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Atogepant 60 mg
Taken once daily
Drug: Atogepant 60 mg
Tablets containing 60 mg of Atogepant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants with at Least 1 Treatment Emergent Adverse Event
Time Frame: 156 weeks
156 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants with Clinically Significant Laboratory Values (Chemistry, Hematology, Urinalysis) as assessed by the Investigator
Time Frame: 156 weeks
156 weeks
Percentage of Participants with Clinically Significant Electrocardiograms (ECGs) Findings as assessed by the Investigator
Time Frame: 156 weeks
156 weeks
Percentage of Participants with Clinically Significant Vital Sign Measurements as assessed by the Investigator
Time Frame: 156 weeks
156 weeks
Columbia-Suicide Severity Rating Scale (C-SSRS) Assessing Suicidal Ideation and Behaviour using 5-Point Scales
Time Frame: 156 weeks
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)
156 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 19, 2021

Primary Completion (Actual)

October 20, 2025

Study Completion (Actual)

October 20, 2025

Study Registration Dates

First Submitted

December 21, 2020

First Submitted That Met QC Criteria

December 23, 2020

First Posted (Actual)

December 28, 2020

Study Record Updates

Last Update Posted (Estimated)

December 18, 2025

Last Update Submitted That Met QC Criteria

December 16, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3101-312-002
  • 2020-002470-27 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

IPD Sharing Time Frame

For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

IPD Sharing Access Criteria

To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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