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

NCT04686136 | Completed Phase 3 DMC FDA Drug

• 2 other identifiers: 3101-312-0022020-002470-27
• Study Type: interventional
• Target: 596
• Locations: 14 countries
• Sites: 116

Brief Summary

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

Conditions

Episodic Migraine; Chronic Migraine

Keywords

Episodic migraine; Chronic migraine

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants with at Least 1 Treatment Emergent Adverse Event

  156 weeks

Secondary Outcomes (4)

• Percentage of Participants with Clinically Significant Laboratory Values (Chemistry, Hematology, Urinalysis) as assessed by the Investigator

  156 weeks

• Percentage of Participants with Clinically Significant Electrocardiograms (ECGs) Findings as assessed by the Investigator

  156 weeks

• Percentage of Participants with Clinically Significant Vital Sign Measurements as assessed by the Investigator

  156 weeks

• Columbia-Suicide Severity Rating Scale (C-SSRS) Assessing Suicidal Ideation and Behaviour using 5-Point Scales

  156 weeks

Study Arms (1)

Atogepant 60 mg

EXPERIMENTAL

Taken once daily

Drug: Atogepant 60 mg

Interventions

Atogepant 60 mg DRUG

Tablets containing 60 mg of Atogepant

Atogepant 60 mg

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (116)

Duplicate_Barrow Neurological Institute /ID# 228217

Phoenix, Arizona, 85013-4407, United States

Location

California Headache and Balance Center /ID# 226241

Fresno, California, 93720, United States

Location

Duplicate_Pharmacology Research Institute (PRI) - Los Alamitos (Wake) /ID# 226404

Los Alamitos, California, 90720-3500, United States

Location

Pharmacology Research Institute (PRI) - Newport Beach (Wake) /ID# 226389

Newport Beach, California, 92660, United States

Location

Excell Research, Inc /ID# 228390

Oceanside, California, 92056, United States

Location

Duplicate_Schuster Medical Research Institute /ID# 226246

Sherman Oaks, California, 91403, United States

Location

Alpine Clinical Research Center /ID# 226203

Boulder, Colorado, 80301-1880, United States

Location

Sensible Healthcare /ID# 226426

Ocoee, Florida, 34761, United States

Location

Accel Research Sites - Tampa Clinical Research Unit /ID# 226252

Tampa, Florida, 33634, United States

Location

NeuroTrials Research Inc /ID# 226477

Atlanta, Georgia, 30342, United States

Location

Allied Physicians - Fort Wayne Neurological Center /ID# 226390

Fort Wayne, Indiana, 46804, United States

Location

Josephson-Wallack-Munshower Neurology - Northeast /ID# 226295

Indianapolis, Indiana, 46256, United States

Location

Collective Medical Research /ID# 226482

Overland Park, Kansas, 66210, United States

Location

Ochsner Clinic Foundation /ID# 228220

Covington, Louisiana, 70433-8107, United States

Location

Pharmasite Research, Inc. /ID# 226444

Baltimore, Maryland, 21208, United States

Location

Beth Israel Deaconess Medical Center /ID# 228214

Boston, Massachusetts, 02215-5400, United States

Location

BTC of New Bedford /ID# 226289

New Bedford, Massachusetts, 02740, United States

Location

Clinical Research Institute, Inc /ID# 226232

Minneapolis, Minnesota, 55402-2606, United States

Location

Headache Neurology Research Institute /ID# 226234

Ridgeland, Mississippi, 39157, United States

Location

StudyMetrix Research /ID# 226296

City of Saint Peters, Missouri, 63303, United States

Location

Clinvest Research LLC /ID# 226275

Springfield, Missouri, 65807, United States

Location

Methodist Physicians Clinic/CCT Research /ID# 226422

Fremont, Nebraska, 68025, United States

Location

Albuquerque Clinical Trials, Inc. /ID# 226523

Albuquerque, New Mexico, 87102, United States

Location

Albany Medical Center Rheumatology /ID# 228212

Albany, New York, 12208-3412, United States

Location

Headache Wellness Center /ID# 226233

Greensboro, North Carolina, 27405, United States

Location

Duplicate_CTI Clinical Research Center /ID# 226278

Cincinnati, Ohio, 45212, United States

Location

Stetson-University of Cincinnati /ID# 226326

Cincinnati, Ohio, 45219, United States

Location

Abington Neurological Associates - Abington /ID# 226449

Abington, Pennsylvania, 19001, United States

Location

Preferred Primary Care Physicians, Inc. /ID# 226447

Pittsburgh, Pennsylvania, 15236, United States

Location

Mount Vernon Clinical Research /ID# 226249

Chattanooga, Tennessee, 37421, United States

Location

CNS Healthcare - Memphis /ID# 226254

Memphis, Tennessee, 38119, United States

Location

FutureSearch Trials of Neurology /ID# 226424

Austin, Texas, 78731, United States

Location

Austin Clinical Trial Partners /ID# 228391

Austin, Texas, 78737, United States

Location

DiscoveResearch, Inc /ID# 226490

Bryan, Texas, 77802, United States

Location

Texas Neurology /ID# 226425

Dallas, Texas, 75214, United States

Location

LinQ Research, LLC /ID# 226391

Pearland, Texas, 77584, United States

Location

J. Lewis Research, Inc. / Foothill Family Clinic /ID# 226248

Salt Lake City, Utah, 84109, United States

Location

J. Lewis Research, Inc. Foothill Family Clinic South /ID# 226328

Salt Lake City, Utah, 84121, United States

Location

Highland Clinical Research /ID# 226287

Salt Lake City, Utah, 84124, United States

Location

Sentara Family Medicine Physicians /ID# 226448

Virginia Beach, Virginia, 23456, United States

Location

Northwest Clinical Research Center /ID# 226240

Bellevue, Washington, 98007, United States

Location

Puget Sound Neurology /ID# 226253

Tacoma, Washington, 25328, United States

Location

CHAMP Clinic /ID# 226256

Calgary, Alberta, T3M 1M4, Canada

Location

Vancouver Island Health Authority /ID# 226255

Victoria, British Columbia, V8R 1J8, Canada

Location

Aggarwal and Associates Limited /ID# 226452

Brampton, Ontario, L6T 0G1, Canada

Location

Ottawa Headache Centre Research Inc /ID# 226451

Ottawa, Ontario, K2G 6E2, Canada

Location

Diex Recherche Sherbrooke Inc. /ID# 226427

Sherbrooke, Quebec, J1L 0H8, Canada

Location

CCR Ostrava, s.r.o. /ID# 228412

Ostrava, Ostrava-mesto, 702 00, Czechia

Location

A-Shine s.r.o. /ID# 226207

Pilsen, Plzeň Region, 301 00, Czechia

Location

NeuroHK s.r.o. /ID# 226429

Hradec Králové, 500 09, Czechia

Location

BRAIN-SOULTHERAPY s.r.o. /ID# 226394

Kladno, 272 01, Czechia

Location

Pratia Pardubice a.s. /ID# 226393

Pardubice, 530 02, Czechia

Location

Clintrial s.r.o. /ID# 228413

Prague, 100 00, Czechia

Location

DADO MEDICAL s.r.o. /ID# 226421

Prague, 120 00, Czechia

Location

Pratia Prague s.r.o. /ID# 226406

Prague, 130 00, Czechia

Location

Fakultni Thomayerova nemocnice /ID# 228409

Prague, 140 59, Czechia

Location

FORBELI s.r.o. /ID# 228406

Prague, 160 00, Czechia

Location

INEP medical s.r.o. /ID# 228411

Prague, 186 00, Czechia

Location

Vestra Clinics s.r.o. /ID# 226453

Rychnov nad Kněžnou, 516 01, Czechia

Location

NeuroMed Zlin s.r.o. /ID# 228414

Zlín, 760 01, Czechia

Location

Rigshospitalet Glostrup /ID# 228417

Glostrup Municipality, Capital Region, 2600, Denmark

Location

CHU Nice - Hopital de Cimiez /ID# 228419

Nice, Alpes-Maritimes, 06000, France

Location

AP-HM - Hopital de la Timone /ID# 226407

Marseille, Bouches-du-Rhone, 13385, France

Location

Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord /ID# 228418

St-Priest-en-Jarez, Pays de la Loire Region, 42270, France

Location

Duplicate_Hôpital Pierre Wertheimer /ID# 226430

Bron, Rhone, 69677, France

Location

CHU Clermont Ferrand - Hopital Gabriel Montpied /ID# 226459

Clermont-Ferrand, 63000, France

Location

AP-HP - Groupe Hospitalier 10e - Hopital Lariboisiere /ID# 226220

Paris, 75010, France

Location

Neuropoint GmbH /ID# 226313

Ulm, Baden-Wurttemberg, 89073, Germany

Location

Neuropraxis Muenchen Sued /ID# 226309

Unterhaching, Bavaria, 82008, Germany

Location

Klinische Forschung Hannover-Mitte GmbH /ID# 226305

Hanover, Lower Saxony, 30159, Germany

Location

Studienzentrum Nord-West /ID# 226310

Westerstede, Lower Saxony, 26655, Germany

Location

AmBeNet GmbH /ID# 226312

Leipzig, Saxony, 04107, Germany

Location

Schmerzklinik Kiel /ID# 226454

Kiel, Schleswig-Holstein, 24149, Germany

Location

Zentrum für Neurologie, Neurochirurgie und Psychiatrie /ID# 229991

Berlin, 10117, Germany

Location

Praxis Dr. Gendolla /ID# 229988

Essen, 45133, Germany

Location

Universitaetsklinikum Essen /ID# 229989

Essen, 45147, Germany

Location

Vitos Orthopaedische Klinik Kassel gemeinnuetzige GmbH /ID# 231571

Kassel, 34131, Germany

Location

Velocity Clinical Research /ID# 226307

Wiesbaden, 65189, Germany

Location

Gyongyosi Bugat Pal Korhaz /ID# 228429

Gyöngyös, Heves County, 3200, Hungary

Location

Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 226409

Kaposvár, Somogy County, 7400, Hungary

Location

Clinexpert Kft /ID# 228431

Budapest, 1033, Hungary

Location

S-Medicon Kft /ID# 228432

Budapest, 1138, Hungary

Location

Azienda Ospedaliero Universitaria Careggi /ID# 228624

Florence, Firenze, 50134, Italy

Location

Ospedale Ss. Filippo e Nicola /ID# 228627

Avezzano, L Aquila, 67051, Italy

Location

Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 228625

Milan, Milano, 20133, Italy

Location

IRCCS San Raffaele /ID# 228436

Rome, Roma, 00163, Italy

Location

Universita di Pavia /ID# 228628

Pavia, 27100, Italy

Location

Fondazione Policlinico Universitario Campus Bio-Medico /ID# 228630

Roma, 00128, Italy

Location

Canisius-Wilhelmina Ziekenhuis /ID# 226410

Nijmegen, Gelderland, 6532 SZ, Netherlands

Location

ZorgSaam Zorggroep Zeeuws-Vlaanderen /ID# 226456

Terneuzen, Zeeland, 4535 PA, Netherlands

Location

Solumed Centrum Medyczne /ID# 226298

Poznan, Greater Poland Voivodeship, 60-529, Poland

Location

Vitamed Galaj i Cichomski Sp.j. /ID# 226416

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-079, Poland

Location

Specjalistyczne Gabinety Sp. z o.o. /ID# 228631

Krakow, Lesser Poland Voivodeship, 30-539, Poland

Location

Centrum Leczenia Padaczki i Migreny /ID# 226458

Krakow, Lesser Poland Voivodeship, 31-209, Poland

Location

Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 226412

Lublin, Lublin Voivodeship, 20-582, Poland

Location

Centrum Medyczne Pratia Gdynia /ID# 226431

Gdynia, Pomeranian Voivodeship, 81-338, Poland

Location

Silmedic Sp. z o.o. /ID# 226457

Katowice, Silesian Voivodeship, 40-282, Poland

Location

EuroMedis sp. z o.o. /ID# 226413

Szczecin, West Pomeranian Voivodeship, 70-111, Poland

Location

MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak /ID# 226417

Wroclaw, 52-210, Poland

Location

Duplicate_Pusan National University Hospital /ID# 231416

Busan, Busan Gwang Yeogsi, 49241, South Korea

Location

Hallym University Dongtan Sacred Heart Hospital /ID# 226264

Hwaseong, Gyeonggido, 18450, South Korea

Location

Nowon Eulji Medical Center, Eulji University /ID# 226261

Seoul, Seoul Teugbyeolsi, 01830, South Korea

Location

Seoul National University Hospital /ID# 226199

Seoul, Seoul Teugbyeolsi, 03080, South Korea

Location

Kangbuk Samsung Hospital /ID# 226263

Seoul, Seoul Teugbyeolsi, 03181, South Korea

Location

Samsung Medical Center /ID# 226280

Seoul, Seoul Teugbyeolsi, 06351, South Korea

Location

Yonsei University Health System Severance Hospital /ID# 226265

Seoul, 03722, South Korea

Location

Duplicate_CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 226335

Pamplona, Navarre, 31008, Spain

Location

Hospital Universitario Vall d'Hebron /ID# 226338

Barcelona, 08035, Spain

Location

Hospital Universitario Virgen del Rocio /ID# 226333

Seville, 41013, Spain

Location

Hospital Clinico Universitario de Valladolid /ID# 226330

Valladolid, 47003, Spain

Location

Kuang-Tien General Hospital /ID# 226259

Taichung, Taichung, 433, Taiwan

Location

Tainan Sin Lau Hospital /ID# 226229

Tainan, Tainan, 70142, Taiwan

Location

Taipei Veterans General Hospital /ID# 226206

Taipei City, Taipei, 11217, Taiwan

Location

Tri-Service General Hospital /ID# 228998

Taipei, 11490, Taiwan

Location

King's College Hospital NHS Foundation Trust /ID# 226524

London, SE5 9RS, United Kingdom

Location

Re:Cognition Health - London /ID# 231205

London, W1G 9JF, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 40831083 DERIVED

Related Links

• Related Info

MeSH Terms

Interventions

atogepant

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2020
• First Posted: December 28, 2020
• Study Start: February 19, 2021
• Primary Completion: October 20, 2025
• Study Completion: October 20, 2025
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

DK (1); PL (9); GB (2); TW (4); KR (7); US (42); IT (6); NL (2); ES (4); HU (4); FR (6); CA (5); CZ (13); DE (11)