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Episodic MigrainePhase 3NCT04686136

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

A Phase 3 study testing Atogepant 60 mg in people with Episodic Migraine and Chronic Migraine, run by AbbVie at 116 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Episodic Migraine, Chronic Migraine
What is being tested?
Atogepant 60 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
596 participants
Where
116 sitesin 14 countries
Study dates
19 Feb 2021to 20 Oct 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

116 sites in 14 countries.

116 sites in 14 countries

United States42 sites

  • Abington Neurological Associates - Abington /ID# 226449

    Abington, Pennsylvania, 19001

  • Albany Medical Center Rheumatology /ID# 228212

    Albany, New York, 12208-3412

  • Albuquerque Clinical Trials, Inc. /ID# 226523

    Albuquerque, New Mexico, 87102

  • NeuroTrials Research Inc /ID# 226477

    Atlanta, Georgia, 30342

  • FutureSearch Trials of Neurology /ID# 226424

    Austin, Texas, 78731

  • Austin Clinical Trial Partners /ID# 228391

    Austin, Texas, 78737

  • Pharmasite Research, Inc. /ID# 226444

    Baltimore, Maryland, 21208

  • Northwest Clinical Research Center /ID# 226240

    Bellevue, Washington, 98007

  • Beth Israel Deaconess Medical Center /ID# 228214

    Boston, Massachusetts, 02215-5400

  • Alpine Clinical Research Center /ID# 226203

    Boulder, Colorado, 80301-1880

  • DiscoveResearch, Inc /ID# 226490

    Bryan, Texas, 77802

  • Mount Vernon Clinical Research /ID# 226249

    Chattanooga, Tennessee, 37421

  • Duplicate_CTI Clinical Research Center /ID# 226278

    Cincinnati, Ohio, 45212

  • Stetson-University of Cincinnati /ID# 226326

    Cincinnati, Ohio, 45219

  • StudyMetrix Research /ID# 226296

    City of Saint Peters, Missouri, 63303

  • Ochsner Clinic Foundation /ID# 228220

    Covington, Louisiana, 70433-8107

  • Texas Neurology /ID# 226425

    Dallas, Texas, 75214

  • Allied Physicians - Fort Wayne Neurological Center /ID# 226390

    Fort Wayne, Indiana, 46804

  • Methodist Physicians Clinic/CCT Research /ID# 226422

    Fremont, Nebraska, 68025

  • California Headache and Balance Center /ID# 226241

    Fresno, California, 93720

  • Headache Wellness Center /ID# 226233

    Greensboro, North Carolina, 27405

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

    Indianapolis, Indiana, 46256

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

    Los Alamitos, California, 90720-3500

  • CNS Healthcare - Memphis /ID# 226254

    Memphis, Tennessee, 38119

  • Clinical Research Institute, Inc /ID# 226232

    Minneapolis, Minnesota, 55402-2606

  • BTC of New Bedford /ID# 226289

    New Bedford, Massachusetts, 02740

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

    Newport Beach, California, 92660

  • Excell Research, Inc /ID# 228390

    Oceanside, California, 92056

  • Sensible Healthcare /ID# 226426

    Ocoee, Florida, 34761

  • Collective Medical Research /ID# 226482

    Overland Park, Kansas, 66210

  • LinQ Research, LLC /ID# 226391

    Pearland, Texas, 77584

  • Duplicate_Barrow Neurological Institute /ID# 228217

    Phoenix, Arizona, 85013-4407

  • Preferred Primary Care Physicians, Inc. /ID# 226447

    Pittsburgh, Pennsylvania, 15236

  • Headache Neurology Research Institute /ID# 226234

    Ridgeland, Mississippi, 39157

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

    Salt Lake City, Utah, 84109

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

    Salt Lake City, Utah, 84121

  • Highland Clinical Research /ID# 226287

    Salt Lake City, Utah, 84124

  • Duplicate_Schuster Medical Research Institute /ID# 226246

    Sherman Oaks, California, 91403

  • Clinvest Research LLC /ID# 226275

    Springfield, Missouri, 65807

  • Puget Sound Neurology /ID# 226253

    Tacoma, Washington, 25328

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

    Tampa, Florida, 33634

  • Sentara Family Medicine Physicians /ID# 226448

    Virginia Beach, Virginia, 23456

Other trials in United States

Czechia13 sites

  • NeuroHK s.r.o. /ID# 226429

    Hradec Králové, 500 09

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

    Kladno, 272 01

  • CCR Ostrava, s.r.o. /ID# 228412

    Ostrava, Ostrava-mesto, 702 00

  • Pratia Pardubice a.s. /ID# 226393

    Pardubice, 530 02

  • A-Shine s.r.o. /ID# 226207

    Pilsen, Plzeň Region, 301 00

  • Clintrial s.r.o. /ID# 228413

    Prague, 100 00

  • DADO MEDICAL s.r.o. /ID# 226421

    Prague, 120 00

  • Pratia Prague s.r.o. /ID# 226406

    Prague, 130 00

  • Fakultni Thomayerova nemocnice /ID# 228409

    Prague, 140 59

  • FORBELI s.r.o. /ID# 228406

    Prague, 160 00

  • INEP medical s.r.o. /ID# 228411

    Prague, 186 00

  • Vestra Clinics s.r.o. /ID# 226453

    Rychnov nad Kněžnou, 516 01

  • NeuroMed Zlin s.r.o. /ID# 228414

    Zlín, 760 01

Other trials in Czechia

Germany11 sites

  • Zentrum für Neurologie, Neurochirurgie und Psychiatrie /ID# 229991

    Berlin, 10117

  • Praxis Dr. Gendolla /ID# 229988

    Essen, 45133

  • Universitaetsklinikum Essen /ID# 229989

    Essen, 45147

  • Klinische Forschung Hannover-Mitte GmbH /ID# 226305

    Hanover, Lower Saxony, 30159

  • Vitos Orthopaedische Klinik Kassel gemeinnuetzige GmbH /ID# 231571

    Kassel, 34131

  • Schmerzklinik Kiel /ID# 226454

    Kiel, Schleswig-Holstein, 24149

  • AmBeNet GmbH /ID# 226312

    Leipzig, Saxony, 04107

  • Neuropoint GmbH /ID# 226313

    Ulm, Baden-Wurttemberg, 89073

  • Neuropraxis Muenchen Sued /ID# 226309

    Unterhaching, Bavaria, 82008

  • Studienzentrum Nord-West /ID# 226310

    Westerstede, Lower Saxony, 26655

  • Velocity Clinical Research /ID# 226307

    Wiesbaden, 65189

Other trials in Germany

Poland9 sites

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

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-079

  • Centrum Medyczne Pratia Gdynia /ID# 226431

    Gdynia, Pomeranian Voivodeship, 81-338

  • Silmedic Sp. z o.o. /ID# 226457

    Katowice, Silesian Voivodeship, 40-282

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

    Krakow, Lesser Poland Voivodeship, 30-539

  • Centrum Leczenia Padaczki i Migreny /ID# 226458

    Krakow, Lesser Poland Voivodeship, 31-209

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

    Lublin, Lublin Voivodeship, 20-582

  • Solumed Centrum Medyczne /ID# 226298

    Poznan, Greater Poland Voivodeship, 60-529

  • EuroMedis sp. z o.o. /ID# 226413

    Szczecin, West Pomeranian Voivodeship, 70-111

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

    Wroclaw, 52-210

Other trials in Poland

South Korea7 sites

  • Duplicate_Pusan National University Hospital /ID# 231416

    Busan, Busan Gwang Yeogsi, 49241

  • Hallym University Dongtan Sacred Heart Hospital /ID# 226264

    Hwaseong, Gyeonggido, 18450

  • Nowon Eulji Medical Center, Eulji University /ID# 226261

    Seoul, Seoul Teugbyeolsi, 01830

  • Seoul National University Hospital /ID# 226199

    Seoul, Seoul Teugbyeolsi, 03080

  • Kangbuk Samsung Hospital /ID# 226263

    Seoul, Seoul Teugbyeolsi, 03181

  • Samsung Medical Center /ID# 226280

    Seoul, Seoul Teugbyeolsi, 06351

  • Yonsei University Health System Severance Hospital /ID# 226265

    Seoul, 03722

Other trials in South Korea

France6 sites

  • Duplicate_Hôpital Pierre Wertheimer /ID# 226430

    Bron, Rhone, 69677

  • CHU Clermont Ferrand - Hopital Gabriel Montpied /ID# 226459

    Clermont-Ferrand, 63000

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

    Marseille, Bouches-du-Rhone, 13385

  • CHU Nice - Hopital de Cimiez /ID# 228419

    Nice, Alpes-Maritimes, 06000

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

    Paris, 75010

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

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

Other trials in France

Italy6 sites

  • Ospedale Ss. Filippo e Nicola /ID# 228627

    Avezzano, L Aquila, 67051

  • Azienda Ospedaliero Universitaria Careggi /ID# 228624

    Florence, Firenze, 50134

  • Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 228625

    Milan, Milano, 20133

  • Universita di Pavia /ID# 228628

    Pavia, 27100

  • Fondazione Policlinico Universitario Campus Bio-Medico /ID# 228630

    Roma, 00128

  • IRCCS San Raffaele /ID# 228436

    Rome, Roma, 00163

Other trials in Italy

Canada5 sites

  • Aggarwal and Associates Limited /ID# 226452

    Brampton, Ontario, L6T 0G1

  • CHAMP Clinic /ID# 226256

    Calgary, Alberta, T3M 1M4

  • Ottawa Headache Centre Research Inc /ID# 226451

    Ottawa, Ontario, K2G 6E2

  • Diex Recherche Sherbrooke Inc. /ID# 226427

    Sherbrooke, Quebec, J1L 0H8

  • Vancouver Island Health Authority /ID# 226255

    Victoria, British Columbia, V8R 1J8

Other trials in Canada

Hungary4 sites

  • Clinexpert Kft /ID# 228431

    Budapest, 1033

  • S-Medicon Kft /ID# 228432

    Budapest, 1138

  • Gyongyosi Bugat Pal Korhaz /ID# 228429

    Gyöngyös, Heves County, 3200

  • Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 226409

    Kaposvár, Somogy County, 7400

Other trials in Hungary

Spain4 sites

  • Hospital Universitario Vall d'Hebron /ID# 226338

    Barcelona, 08035

  • Duplicate_CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 226335

    Pamplona, Navarre, 31008

  • Hospital Universitario Virgen del Rocio /ID# 226333

    Seville, 41013

  • Hospital Clinico Universitario de Valladolid /ID# 226330

    Valladolid, 47003

Other trials in Spain

Taiwan4 sites

  • Kuang-Tien General Hospital /ID# 226259

    Taichung, Taichung, 433

  • Tainan Sin Lau Hospital /ID# 226229

    Tainan, Tainan, 70142

  • Tri-Service General Hospital /ID# 228998

    Taipei, 11490

  • Taipei Veterans General Hospital /ID# 226206

    Taipei City, Taipei, 11217

Other trials in Taiwan

Netherlands2 sites

  • Canisius-Wilhelmina Ziekenhuis /ID# 226410

    Nijmegen, Gelderland, 6532 SZ

  • ZorgSaam Zorggroep Zeeuws-Vlaanderen /ID# 226456

    Terneuzen, Zeeland, 4535 PA

Other trials in Netherlands

United Kingdom2 sites

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

    London, SE5 9RS

  • Re:Cognition Health - London /ID# 231205

    London, W1G 9JF

Other trials in United Kingdom

Denmark1 site

  • Rigshospitalet Glostrup /ID# 228417

    Glostrup Municipality, Capital Region, 2600

Other trials in Denmark

About this study

Official title: 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

Being tested
Atogepant 60 mg
Keywords
Episodic migraine, Chronic migraine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Atogepant 60 mgDrug

    Tablets containing 60 mg of Atogepant

Study groups in NCT04686136
Study groupRoleWhat they receive
Atogepant 60 mgExperimentalTaken once daily
Receives: Drug: Atogepant 60 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 156 weeks

Secondary outcomes (4)

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

    Measured: 156 weeks

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

    Measured: 156 weeks

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

    Measured: 156 weeks

  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)

    Measured: 156 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Dec 2020
  2. Study start19 Feb 2021
  3. Primary completion20 Oct 2025
  4. Study completion20 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
596 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04686136
Sponsor's protocol ID
3101-312-002
Other IDs
2020-002470-27
Status last verified
Dec 2025
First submitted
21 Dec 2020
Last updated
18 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 40831083

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Atogepant 60 mg in people with Episodic Migraine and Chronic Migraine, run by AbbVie at 116 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 116 sites in United States, Czechia, Germany, Poland, South Korea and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants with at Least 1 Treatment Emergent Adverse Event (time frame: 156 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04686136, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025; AzTrials last refreshed its copy on 27 Oct 2026.

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