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

April 16, 2024 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

Active, not recruiting

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 Kralove, Czechia, 500 09
        • NeuroHK s.r.o. /ID# 226429
      • Kladno, Czechia, 272 01
        • BRAIN-SOULTHERAPY s.r.o. /ID# 226394
      • Ostrava, Czechia, 702 00
        • CCR Ostrava, s.r.o. /ID# 228412
      • Pardubice, Czechia, 530 02
        • Pratia Pardubice a.s. /ID# 226393
      • Plzen, Czechia, 301 00
        • A-Shine s.r.o. /ID# 226207
      • Prague, Czechia, 160 00
        • FORBELI s.r.o. /ID# 228406
      • Prague, Czechia, 130 00
        • Pratia Prague s.r.o. /ID# 226406
      • Prague 10, Czechia, 100 00
        • Clintrial s.r.o. /ID# 228413
      • Praha, Czechia, 120 00
        • DADO MEDICAL s.r.o. /ID# 226421
      • Praha, Czechia, 186 00
        • INEP medical s.r.o. /ID# 228411
      • Praha, Czechia, 140 59
        • Fakultni Thomayerova nemocnice /ID# 228409
      • Rychnov nad Kneznou, Czechia, 516 01
        • Vestra Clinics s.r.o. /ID# 226453
      • Zlin, Czechia, 760 01
        • NeuroMed Zlin s.r.o. /ID# 228414
  • Denmark
    • Hovedstaden
      • Glostrup, Hovedstaden, Denmark, 2600
        • Rigshospitalet Glostrup /ID# 228417
  • France
      • Bron, France, 69677
        • Hôpital Pierre Wertheimer /ID# 226430
      • Clermont Ferrand, France, 63000
        • CHU Clermont Ferrand - Hopital Gabriel Montpied /ID# 226459
      • Paris, France, 75010
        • AP-HP - Hopital Lariboisière /ID# 226220
      • St-Priest-en-Jarez, France, 42270
        • Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord /ID# 228418
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, France, 06000
        • CHU Nice - Hopital de Cimiez /ID# 228419
    • Bouches-du-Rhone
      • Marseille CEDEX 05, Bouches-du-Rhone, France, 13385
        • AP-HM - Hopital de la Timone /ID# 226407
  • 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
      • Kiel, Germany, 24149
        • Schmerzklinik Kiel /ID# 226454
      • Leipzig, Germany, 04107
        • AmBeNet GmbH /ID# 226312
      • Ulm, Germany, 89073
        • Neuropoint GmbH /ID# 226313
      • Unterhaching, Germany, 82008
        • Neuropraxis Muenchen Sued /ID# 226309
      • Westerstede, Germany, 26655
        • Studienzentrum Nord-West /ID# 226310
      • Wiesbaden, Germany, 65189
        • Intermed GmbH /ID# 226307
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30159
        • Klinische Forschung Hannover-Mitte GmbH /ID# 226305
  • Hungary
      • Budapest, Hungary, 1033
        • Clinexpert Kft /ID# 228431
      • Budapest, Hungary, 1138
        • S-Medicon Kft /ID# 228432
    • Heves
      • Gyongyos, Heves, Hungary, 3200
        • Gyongyosi Bugat Pal Korhaz /ID# 228429
    • Somogy
      • Kaposvár, Somogy, Hungary, 7400
        • Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 226409
  • Italy
      • Florence, Italy, 50134
        • Azienda Ospedaliero Universitaria Careggi /ID# 228624
      • Milano, Italy, 20133
        • Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 228625
      • Pavia, Italy, 27100
        • Universita di Pavia /ID# 228628
    • L Aquila
      • Avezzano, L Aquila, Italy, 67051
        • Ospedale Ss. Filippo e Nicola /ID# 228627
    • Roma
      • Rome, Roma, Italy, 00128
        • Fondazione Policlinico Universitario Campus Bio-Medico di Roma /ID# 228630
      • Rome, Roma, Italy, 00163
        • IRCCS San Raffaele Pisana /ID# 228436
  • Korea, Republic of
      • Busan, Korea, Republic of, 49241
        • Pusan National University Hospital /ID# 231416
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital /ID# 226199
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center /ID# 226280
      • 노원구, Korea, Republic of, 01830
        • Nowon Eulji Medical Center, Eulji University /ID# 226261
    • Gyeonggido
      • Hwaseong, Gyeonggido, Korea, Republic of, 18450
        • Dongtan Sacred Heart Hospital /ID# 226264
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03181
        • Kangbuk Samsung Hospital /ID# 226263
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03722
        • Yonsei University Health System Severance Hospital /ID# 226265
  • Netherlands
      • Nijmegen, Netherlands, 6532 SZ
        • Canisius-Wilhelmina Ziekenhuis /ID# 226410
      • Terneuzen, Netherlands, 4535 PA
        • ZorgSaam Zorggroep Zeeuws-Vlaanderen /ID# 226456
  • Poland
      • Wroclaw, Poland, 52-210
        • MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak /ID# 226417
    • Kujawsko-pomorskie
      • Bydgoszcz, Kujawsko-pomorskie, Poland, 85-079
        • Vitamed Galaj i Cichomski Sp.j. /ID# 226416
    • Lubelskie
      • Lublin, Lubelskie, Poland, 20-582
        • Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 226412
    • Malopolskie
      • Krakow, Malopolskie, Poland, 30-539
        • Specjalistyczne Gabinety Sp. z o.o. /ID# 228631
      • Krakow, Malopolskie, Poland, 31-209
        • Centrum Leczenia Padaczki i Migreny /ID# 226458
    • Pomorskie
      • Gdynia, Pomorskie, Poland, 81-338
        • Centrum Medyczne Pratia Gdynia /ID# 226431
    • Slaskie
      • Katowice, Slaskie, Poland, 40-282
        • Silmedic Sp. z o.o. /ID# 226457
    • Wielkopolskie
      • Poznan, Wielkopolskie, Poland, 60-529
        • Solumed Centrum Medyczne /ID# 226298
    • Zachodniopomorskie
      • Szczecin, Zachodniopomorskie, Poland, 70-111
        • EuroMedis sp. z o.o. /ID# 226413
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitario Vall d'Hebron /ID# 226338
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen del Rocio /ID# 226333
      • Valladolid, Spain, 47003
        • Hospital Clinico Universitario de Valladolid /ID# 226330
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Duplicate_CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 226335
  • Taiwan
      • Taichung City, Taiwan, 433
        • Kuang-Tien General Hospital /ID# 226259
      • Tainan City, Taiwan, 70142
        • Tainan Sin Lau Hospital /ID# 226229
      • Taipei City, Taiwan, 11490
        • Tri-Service General Hospital /ID# 228998
    • 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
        • 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
        • 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
        • 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
      • 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.

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 (Estimated)

October 8, 2025

Study Completion (Estimated)

October 8, 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 (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

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 data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

IPD Sharing Time Frame

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

IPD Sharing Access Criteria

Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on 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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