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NCT04686136CompletedPhase 3

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

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

Source: ClinicalTrials.gov · Last updated 18 Dec 2025

Brief summary (registry, in English)

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

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
596 (actual)
First submitted
21 Dec 2020
Start date
19 Feb 2021
Primary completion date
20 Oct 2025
Lead sponsor
AbbVie
Diseases
Migraine
NCT number
NCT04686136
EU CT number
2023-507096-21-00
EudraCT number
2020-002470-27

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 596
  • From 19 Feb 2021 to the primary completion date, 20 Oct 2025
  • 115 sites in 14 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • Participants with hypertension at Visit 1.
  • Participants with clinically significant hematologic, endocrine, cardiovascular, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.

Other

  • Participants with an ECG indicating clinically significant abnormalities 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.

Who the study is looking for

  • \- 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.

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (115)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Aggarwal and Associates Limited /ID# 226452
Coordinator of this site? Confirm its status
BramptonCanadaUnknown status
CHAMP Clinic /ID# 226256
Coordinator of this site? Confirm its status
CalgaryCanadaUnknown status
Ottawa Headache Centre Research Inc /ID# 226451
Coordinator of this site? Confirm its status
OttawaCanadaUnknown status
Diex Recherche Sherbrooke Inc. /ID# 226427
Coordinator of this site? Confirm its status
SherbrookeCanadaUnknown status
Vancouver Island Health Authority /ID# 226255
Coordinator of this site? Confirm its status
VictoriaCanadaUnknown status
NEUROHK s r o
Coordinator of this site? Confirm its status
ChoceňCzechiaCompleted
Brain-Soultherapy s.r.o.
Coordinator of this site? Confirm its status
KladnoCzechiaCompleted
CCR Ostrava s.r.o.
Coordinator of this site? Confirm its status
Moravska Ostrava A PrivozCzechiaCompleted
Pratia Pardubice a.s.
Coordinator of this site? Confirm its status
Pardubice ICzechiaCompleted
A-Shine s.r.o.
Coordinator of this site? Confirm its status
Plzen 3CzechiaCompleted
INEP medical s.r.o.
Coordinator of this site? Confirm its status
PragueCzechiaCompleted
DADO MEDICAL s.r.o.
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PragueCzechiaCompleted
FORBELI s.r.o.
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PragueCzechiaCompleted
Clintrial s.r.o.
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Prague 10CzechiaCompleted
Pratia Prague s.r.o.
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Prague 3CzechiaCompleted
Fakultni Thomayerova nemocnice
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Prague 4CzechiaCompleted
Vestra Clinics s.r.o.
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Rychnov nad KněžnouCzechiaCompleted
NeuroMed Zlin s.r.o.
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ZlínCzechiaCompleted
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyCompleted
Praxis Dr. Gendolla
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EssenGermanyCompleted
Universitaetsklinikum Essen (AoR)
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EssenGermanyCompleted
Klinische Forschung Hannover-Mitte GmbH
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HanoverGermanyCompleted
University Hospital Jena KöR
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JenaGermanyCompleted
Vitos Orthopaedische Klinik Kassel gGmbH
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KasselGermanyCompleted
Schmerzklinik Kiel Gmbh & Co. KG Klinik fuer neurologisch-verhaltensmedizinische Schmerztherapie
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KielGermanyCompleted
Ambenet GmbH Das Ambulante Behandlungsnetz
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LeipzigGermanyCompleted
NeuroPoint Gesellschaft fur vorbeugende Gesundheitspflege GmbH
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UlmGermanyCompleted
Neuropraxis Muenchen Sued
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UnterhachingGermanyCompleted
Dr. med. Joachim Springub Facharzt fuer Neurologie u. Psychiatrie Zusatzbezeichnung Psychotherapie Wolfgang Schwarz Facharzt fuer Neurologie Zusatzbezeichnung Psychotherapie Partnerschaft
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WesterstedeGermanyCompleted
Intermed Institut fuer medizinische Forschung und Arzneimittelsicherheit GmbH
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WiesbadenGermanyCompleted
Rigshospitalet
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GlostrupDenmarkCompleted
Hospital Universitari Vall d'Hebron
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BarcelonaSpainCompleted
University Hospital Virgen Del Rocio S.L.
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SevillaSpainCompleted
Hospital Clínico Universitario de Valladolid
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ValladolidSpainCompleted
Chu Gabriel Montpied
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Clermont-FerrandFranceCompleted
Assistance Publique Hôpitaux de Marseille
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MarseilleFranceCompleted
Centre Hospitalier Universitaire de Nice
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NiceFranceCompleted
Assistance Publique Hopitaux De Paris
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Paris Cedex 10FranceCompleted
Centre Hospitalier Universitaire de Saint Etienne
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Saint-Priest-en-JarezFranceCompleted
Re:Cognition Health - London /ID# 231205
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LondonUnited KingdomUnknown status
King's College Hospital NHS Foundation Trust /ID# 226524
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LondonUnited KingdomUnknown status
Clinexpert Kft.
Coordinator of this site? Confirm its status
Budapest IIIHungaryCompleted
S-Medicon Kft.
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Budapest XIIIHungaryCompleted
Gyöngyösi Bugát Pál Kórház
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GyongyosHungaryCompleted
Somogy Vármegyei Kaposi Mór Oktató Kórház
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KaposvárHungaryCompleted
Careggi University Hospital
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FlorenceItalyCompleted
Azienda Sanitaria Locale Avezzano Sulmona L'Aquila
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L'aquilaItalyCompleted
IRCCS Foundation Istituto Neurologico Carlo Besta
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MilanItalyCompleted
Neurological Institute Foundation Casimiro Mondino
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PaviaItalyCompleted
Irccs San Raffaele Roma S.r.l.
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RomeItalyCompleted
Fondazione Policlinico Universitario Campus Bio-Medico
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RomeItalyCompleted
Duplicate_Pusan National University Hospital /ID# 231416
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BusanSouth KoreaUnknown status
Hallym University Dongtan Sacred Heart Hospital /ID# 226264
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HwaseongSouth KoreaUnknown status
Yonsei University Health System Severance Hospital /ID# 226265
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SeoulSouth KoreaUnknown status
Nowon Eulji Medical Center, Eulji University /ID# 226261
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SeoulSouth KoreaUnknown status
Samsung Medical Center /ID# 226280
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SeoulSouth KoreaUnknown status
Seoul National University Hospital /ID# 226199
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SeoulSouth KoreaUnknown status
Kangbuk Samsung Hospital /ID# 226263
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SeoulSouth KoreaUnknown status
Canisius-Wilhelmina Hospital
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NijmegenNetherlandsCompleted
ZorgSaam Ziekenhuis
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TerneuzenNetherlandsCompleted
Vitamed Galaj i Cichomski sp.j.
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BydgoszczPolandCompleted
Specjalistyczne Gabinety Sp. z o.o.
Coordinator of this site? Confirm its status
CracowPolandCompleted
Centrum Leczenia Padaczki I Migreny S.A.
Coordinator of this site? Confirm its status
CracowPolandCompleted
Pratia S.A.
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GdyniaPolandCompleted
Silmedic Sp. z o.o.
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KatowicePolandCompleted
Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej
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LublinPolandCompleted
Solumed Sp. z o.o. sp.k.
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PoznanPolandCompleted
EUROMEDIS Sp z o o
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SzczecinPolandCompleted
MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
Coordinator of this site? Confirm its status
WrocławPolandCompleted
Kuang-Tien General Hospital /ID# 226259
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TaichungTaiwanUnknown status
Tainan Sin Lau Hospital /ID# 226229
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TainanTaiwanUnknown status
Tri-Service General Hospital /ID# 228998
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TaipeiTaiwanUnknown status
Taipei Veterans General Hospital /ID# 226206
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Taipei CityTaiwanUnknown status
Abington Neurological Associates - Abington /ID# 226449
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AbingtonUnited StatesUnknown status
Albany Medical Center Rheumatology /ID# 228212
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AlbanyUnited StatesUnknown status
Albuquerque Clinical Trials, Inc. /ID# 226523
Coordinator of this site? Confirm its status
AlbuquerqueUnited StatesUnknown status
NeuroTrials Research Inc /ID# 226477
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AtlantaUnited StatesUnknown status
FutureSearch Trials of Neurology /ID# 226424
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AustinUnited StatesUnknown status
Austin Clinical Trial Partners /ID# 228391
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AustinUnited StatesUnknown status
Pharmasite Research, Inc. /ID# 226444
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BaltimoreUnited StatesUnknown status
Northwest Clinical Research Center /ID# 226240
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BellevueUnited StatesUnknown status
Beth Israel Deaconess Medical Center /ID# 228214
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BostonUnited StatesUnknown status
Alpine Clinical Research Center /ID# 226203
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BoulderUnited StatesUnknown status
DiscoveResearch, Inc /ID# 226490
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BryanUnited StatesUnknown status
Mount Vernon Clinical Research /ID# 226249
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ChattanoogaUnited StatesUnknown status
Duplicate_CTI Clinical Research Center /ID# 226278
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CincinnatiUnited StatesUnknown status
Stetson-University of Cincinnati /ID# 226326
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CincinnatiUnited StatesUnknown status
StudyMetrix Research /ID# 226296
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City of Saint PetersUnited StatesUnknown status
Ochsner Clinic Foundation /ID# 228220
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CovingtonUnited StatesUnknown status
Texas Neurology /ID# 226425
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DallasUnited StatesUnknown status
Allied Physicians - Fort Wayne Neurological Center /ID# 226390
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Fort WayneUnited StatesUnknown status
Methodist Physicians Clinic/CCT Research /ID# 226422
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FremontUnited StatesUnknown status
California Headache and Balance Center /ID# 226241
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FresnoUnited StatesUnknown status
Headache Wellness Center /ID# 226233
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GreensboroUnited StatesUnknown status
Josephson-Wallack-Munshower Neurology - Northeast /ID# 226295
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IndianapolisUnited StatesUnknown status
Duplicate_Pharmacology Research Institute (PRI) - Los Alamitos (Wake) /ID# 226404
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Los AlamitosUnited StatesUnknown status
CNS Healthcare - Memphis /ID# 226254
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MemphisUnited StatesUnknown status
Clinical Research Institute, Inc /ID# 226232
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MinneapolisUnited StatesUnknown status
BTC of New Bedford /ID# 226289
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New BedfordUnited StatesUnknown status
Pharmacology Research Institute (PRI) - Newport Beach (Wake) /ID# 226389
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Newport BeachUnited StatesUnknown status
Excell Research, Inc /ID# 228390
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OceansideUnited StatesUnknown status
Sensible Healthcare /ID# 226426
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OcoeeUnited StatesUnknown status
Collective Medical Research /ID# 226482
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Overland ParkUnited StatesUnknown status
LinQ Research, LLC /ID# 226391
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PearlandUnited StatesUnknown status
Duplicate_Barrow Neurological Institute /ID# 228217
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PhoenixUnited StatesUnknown status
Preferred Primary Care Physicians, Inc. /ID# 226447
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PittsburghUnited StatesUnknown status
Headache Neurology Research Institute /ID# 226234
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RidgelandUnited StatesUnknown status
J. Lewis Research, Inc. / Foothill Family Clinic /ID# 226248
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Salt Lake CityUnited StatesUnknown status
Highland Clinical Research /ID# 226287
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Salt Lake CityUnited StatesUnknown status
J. Lewis Research, Inc. Foothill Family Clinic South /ID# 226328
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Salt Lake CityUnited StatesUnknown status
Duplicate_Schuster Medical Research Institute /ID# 226246
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Sherman OaksUnited StatesUnknown status
Clinvest Research LLC /ID# 226275
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SpringfieldUnited StatesUnknown status
Puget Sound Neurology /ID# 226253
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TacomaUnited StatesUnknown status
Accel Research Sites - Tampa Clinical Research Unit /ID# 226252
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TampaUnited StatesUnknown status
Sentara Family Medicine Physicians /ID# 226448
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Virginia BeachUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.