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

ClinicalTrials.gov processed this data on April 16, 2024. Link to the current ClinicalTrials.gov record.

Recruitment Status

ACTIVE, NOT RECRUITING (See Contacts and Locations)
Verified April 2024 by AbbVie

Sponsor

AbbVie

Information Provided by (Responsible Party)

AbbVie

Clinicaltrials.gov Identifier

NCT04686136
Other Study ID Numbers: 3101-312-002
First Submitted: December 21, 2020
First Posted: December 28, 2020
Last Update Posted: April 17, 2024
Last Verified: April 2024
History of Changes

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Study Description

Not Provided
Condition or Disease Intervention/Treatment
  • Episodic Migraine
  • Chronic Migraine
  • Drug: Atogepant 60 mg

Study Design

Study TypeInterventional
Actual Enrollment596 participants
Design AllocationN/A
Interventional ModelSingle Group Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleA 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
Study Start DateFebruary 19, 2021
Anticipated Primary Completion DateOctober 8, 2025
Anticipated Study Completion DateOctober 8, 2025

Groups and Cohorts

Group/ CohortIntervention/ Treatment
  • Atogepant 60 mg
    • Taken once daily
  • Drug: Atogepant 60 mg
    • Tablets containing 60 mg of Atogepant

Outcome Measures

Primary Outcome Measures

  1. Percentage of Participants with at Least 1 Treatment Emergent Adverse Event [156 weeks]

Secondary Outcome Measures

  1. Percentage of Participants with Clinically Significant Laboratory Values (Chemistry, Hematology, Urinalysis) as assessed by the Investigator [156 weeks]
  2. Percentage of Participants with Clinically Significant Electrocardiograms (ECGs) Findings as assessed by the Investigator [156 weeks]
  3. Percentage of Participants with Clinically Significant Vital Sign Measurements as assessed by the Investigator [156 weeks]
  4. Columbia-Suicide Severity Rating Scale (C-SSRS) Assessing Suicidal Ideation and Behaviour using 5-Point Scales [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)

Eligibility Criteria

Ages Eligible for Study 18 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study All
Accepts Healthy Volunteers No
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.

Contacts and Locations

Sponsors and Collaborators AbbVie
Locations
  • Barrow Neurological Institute /ID# 228217 | Phoenix, Arizona, United States, 85013-4407
  • California Headache and Balance Center /ID# 226241 | Fresno, California, United States, 93720
  • Pharmacology Research Institute (PRI) - Los Alamitos (Wake) /ID# 226404 | Los Alamitos, California, United States, 90720-3500
  • Pharmacology Research Institute (PRI) - Newport Beach (Wake) /ID# 226389 | Newport Beach, California, United States, 92660
  • Excell Research, Inc /ID# 228390 | Oceanside, California, United States, 92056
  • Schuster Medical Research Institute /ID# 226246 | Sherman Oaks, California, United States, 91403
  • Alpine Clinical Research Center /ID# 226203 | Boulder, Colorado, United States, 80301-1880
  • Sensible Healthcare /ID# 226426 | Ocoee, Florida, United States, 34761
  • Accel Research Sites - Tampa Clinical Research Unit /ID# 226252 | Tampa, Florida, United States, 33634
  • NeuroTrials Research Inc /ID# 226477 | Atlanta, Georgia, United States, 30342
  • Allied Physicians - Fort Wayne Neurological Center /ID# 226390 | Fort Wayne, Indiana, United States, 46804
  • Josephson-Wallack-Munshower Neurology - Northeast /ID# 226295 | Indianapolis, Indiana, United States, 46256
  • Collective Medical Research /ID# 226482 | Overland Park, Kansas, United States, 66210
  • Ochsner Clinic Foundation /ID# 228220 | Covington, Louisiana, United States, 70433-8107
  • Pharmasite Research, Inc. /ID# 226444 | Baltimore, Maryland, United States, 21208
  • Beth Israel Deaconess Medical Center /ID# 228214 | Boston, Massachusetts, United States, 02215-5400
  • BTC of New Bedford /ID# 226289 | New Bedford, Massachusetts, United States, 02740
  • Clinical Research Institute, Inc /ID# 226232 | Minneapolis, Minnesota, United States, 55402-2606
  • Headache Neurology Research Institute /ID# 226234 | Ridgeland, Mississippi, United States, 39157
  • StudyMetrix Research /ID# 226296 | Saint Peters, Missouri, United States, 63303
  • Clinvest Research LLC /ID# 226275 | Springfield, Missouri, United States, 65807
  • Methodist Physicians Clinic/CCT Research /ID# 226422 | Fremont, Nebraska, United States, 68025
  • Albuquerque Clinical Trials, Inc /ID# 226523 | Albuquerque, New Mexico, United States, 87102
  • Albany Medical Center Rheumatology /ID# 228212 | Albany, New York, United States, 12208-3412
  • Headache Wellness Center /ID# 226233 | Greensboro, North Carolina, United States, 27405
  • Duplicate_CTI Clinical Research Center /ID# 226278 | Cincinnati, Ohio, United States, 45212
  • Stetson-University of Cincinnati /ID# 226326 | Cincinnati, Ohio, United States, 45219
  • Abington Neurological Associates - Abington /ID# 226449 | Abington, Pennsylvania, United States, 19001
  • Preferred Primary Care Physicians, Inc. /ID# 226447 | Pittsburgh, Pennsylvania, United States, 15236
  • Mount Vernon Clinical Research /ID# 226249 | Chattanooga, Tennessee, United States, 37421
  • CNS Healthcare - Memphis /ID# 226254 | Memphis, Tennessee, United States, 38119
  • FutureSearch Trials of Neurology /ID# 226424 | Austin, Texas, United States, 78731
  • Austin Clinical Trial Partners /ID# 228391 | Austin, Texas, United States, 78737
  • DiscoveResearch, Inc /ID# 226490 | Bryan, Texas, United States, 77802
  • Texas Neurology /ID# 226425 | Dallas, Texas, United States, 75214
  • LinQ Research, LLC /ID# 226391 | Pearland, Texas, United States, 77584
  • J. Lewis Research, Inc. / Foothill Family Clinic /ID# 226248 | Salt Lake City, Utah, United States, 84109
  • J. Lewis Research, Inc. Foothill Family Clinic South /ID# 226328 | Salt Lake City, Utah, United States, 84121
  • Highland Clinical Research /ID# 226287 | Salt Lake City, Utah, United States, 84124
  • Sentara Family Medicine Physicians /ID# 226448 | Virginia Beach, Virginia, United States, 23456
  • Northwest Clinical Research Center /ID# 226240 | Bellevue, Washington, United States, 98007
  • Puget Sound Neurology /ID# 226253 | Tacoma, Washington, United States, 25328
  • CHAMP Clinic /ID# 226256 | Calgary, Alberta, Canada, T3M 1M4
  • Vancouver Island Health Authority /ID# 226255 | Victoria, British Columbia, Canada, V8R 1J8
  • Aggarwal and Associates Limited /ID# 226452 | Brampton, Ontario, Canada, L6T 0G1
  • Ottawa Headache Centre Research Inc /ID# 226451 | Ottawa, Ontario, Canada, K2G 6E2
  • Diex Recherche Sherbrooke Inc. /ID# 226427 | Sherbrooke, Quebec, Canada, J1L 0H8
  • NeuroHK s.r.o. /ID# 226429 | Hradec Kralove, Czechia, 500 09
  • BRAIN-SOULTHERAPY s.r.o. /ID# 226394 | Kladno, Czechia, 272 01
  • CCR Ostrava, s.r.o. /ID# 228412 | Ostrava, Czechia, 702 00
  • Pratia Pardubice a.s. /ID# 226393 | Pardubice, Czechia, 530 02
  • A-Shine s.r.o. /ID# 226207 | Plzen, Czechia, 301 00
  • Clintrial s.r.o. /ID# 228413 | Prague 10, Czechia, 100 00
  • Pratia Prague s.r.o. /ID# 226406 | Prague, Czechia, 130 00
  • FORBELI s.r.o. /ID# 228406 | Prague, Czechia, 160 00
  • DADO MEDICAL s.r.o. /ID# 226421 | Praha, Czechia, 120 00
  • Fakultni Thomayerova nemocnice /ID# 228409 | Praha, Czechia, 140 59
  • INEP medical s.r.o. /ID# 228411 | Praha, Czechia, 186 00
  • Vestra Clinics s.r.o. /ID# 226453 | Rychnov nad Kneznou, Czechia, 516 01
  • NeuroMed Zlin s.r.o. /ID# 228414 | Zlin, Czechia, 760 01
  • Rigshospitalet Glostrup /ID# 228417 | Glostrup, Hovedstaden, Denmark, 2600
  • CHU Nice - Hopital de Cimiez /ID# 228419 | Nice, Alpes-Maritimes, France, 06000
  • AP-HM - Hopital de la Timone /ID# 226407 | Marseille CEDEX 05, Bouches-du-Rhone, France, 13385
  • Hôpital Pierre Wertheimer /ID# 226430 | Bron, France, 69677
  • CHU Clermont Ferrand - Hopital Gabriel Montpied /ID# 226459 | Clermont Ferrand, France, 63000
  • AP-HP - Hopital Lariboisière /ID# 226220 | Paris, France, 75010
  • Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord /ID# 228418 | St-Priest-en-Jarez, France, 42270
  • Klinische Forschung Hannover-Mitte GmbH /ID# 226305 | Hannover, Niedersachsen, Germany, 30159
  • Zentrum für Neurologie, Neurochirurgie und Psychiatrie /ID# 229991 | Berlin, Germany, 10117
  • Praxis Dr. Gendolla /ID# 229988 | Essen, Germany, 45133
  • Universitaetsklinikum Essen /ID# 229989 | Essen, Germany, 45147
  • Vitos Orthopaedische Klinik Kassel gemeinnuetzige GmbH /ID# 231571 | Kassel, Germany, 34131
  • Schmerzklinik Kiel /ID# 226454 | Kiel, Germany, 24149
  • AmBeNet GmbH /ID# 226312 | Leipzig, Germany, 04107
  • Neuropoint GmbH /ID# 226313 | Ulm, Germany, 89073
  • Neuropraxis Muenchen Sued /ID# 226309 | Unterhaching, Germany, 82008
  • Studienzentrum Nord-West /ID# 226310 | Westerstede, Germany, 26655
  • Intermed GmbH /ID# 226307 | Wiesbaden, Germany, 65189
  • Gyongyosi Bugat Pal Korhaz /ID# 228429 | Gyongyos, Heves, Hungary, 3200
  • Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 226409 | Kaposvár, Somogy, Hungary, 7400
  • Clinexpert Kft /ID# 228431 | Budapest, Hungary, 1033
  • S-Medicon Kft /ID# 228432 | Budapest, Hungary, 1138
  • Ospedale Ss. Filippo e Nicola /ID# 228627 | Avezzano, L Aquila, Italy, 67051
  • Fondazione Policlinico Universitario Campus Bio-Medico di Roma /ID# 228630 | Rome, Roma, Italy, 00128
  • IRCCS San Raffaele Pisana /ID# 228436 | Rome, Roma, Italy, 00163
  • Azienda Ospedaliero Universitaria Careggi /ID# 228624 | Florence, Italy, 50134
  • Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 228625 | Milano, Italy, 20133
  • Universita di Pavia /ID# 228628 | Pavia, Italy, 27100
  • Dongtan Sacred Heart Hospital /ID# 226264 | Hwaseong, Gyeonggido, Korea, Republic of, 18450
  • Kangbuk Samsung Hospital /ID# 226263 | Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03181
  • Yonsei University Health System Severance Hospital /ID# 226265 | Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03722
  • Pusan National University Hospital /ID# 231416 | Busan, Korea, Republic of, 49241
  • Seoul National University Hospital /ID# 226199 | Seoul, Korea, Republic of, 03080
  • Samsung Medical Center /ID# 226280 | Seoul, Korea, Republic of, 06351
  • Nowon Eulji Medical Center, Eulji University /ID# 226261 | 노원구, Korea, Republic of, 01830
  • Canisius-Wilhelmina Ziekenhuis /ID# 226410 | Nijmegen, Netherlands, 6532 SZ
  • ZorgSaam Zorggroep Zeeuws-Vlaanderen /ID# 226456 | Terneuzen, Netherlands, 4535 PA
  • Vitamed Galaj i Cichomski Sp.j. /ID# 226416 | Bydgoszcz, Kujawsko-pomorskie, Poland, 85-079
  • Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 226412 | Lublin, Lubelskie, Poland, 20-582
  • Specjalistyczne Gabinety Sp. z o.o. /ID# 228631 | Krakow, Malopolskie, Poland, 30-539
  • Centrum Leczenia Padaczki i Migreny /ID# 226458 | Krakow, Malopolskie, Poland, 31-209
  • Centrum Medyczne Pratia Gdynia /ID# 226431 | Gdynia, Pomorskie, Poland, 81-338
  • Silmedic Sp. z o.o. /ID# 226457 | Katowice, Slaskie, Poland, 40-282
  • Solumed Centrum Medyczne /ID# 226298 | Poznan, Wielkopolskie, Poland, 60-529
  • EuroMedis sp. z o.o. /ID# 226413 | Szczecin, Zachodniopomorskie, Poland, 70-111
  • MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak /ID# 226417 | Wroclaw, Poland, 52-210
  • Duplicate_CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 226335 | Pamplona, Navarra, Spain, 31008
  • Hospital Universitario Vall d'Hebron /ID# 226338 | Barcelona, Spain, 08035
  • Hospital Universitario Virgen del Rocio /ID# 226333 | Sevilla, Spain, 41013
  • Hospital Clinico Universitario de Valladolid /ID# 226330 | Valladolid, Spain, 47003
  • Taipei Veterans General Hospital /ID# 226206 | Taipei City, Taipei, Taiwan, 11217
  • Kuang-Tien General Hospital /ID# 226259 | Taichung City, Taiwan, 433
  • Tainan Sin Lau Hospital /ID# 226229 | Tainan City, Taiwan, 70142
  • Tri-Service General Hospital /ID# 228998 | Taipei City, Taiwan, 11490
  • King's College Hospital NHS Foundation Trust /ID# 226524 | London, United Kingdom, SE5 9RS
  • Re:Cognition Health - London /ID# 231205 | London, United Kingdom, W1G 9JF
Investigators

    More Information

    Additional Information

    Additional Relevant MeSH Terms

    • Migraine Disorders
    • Headache Disorders, Primary
    • Headache Disorders
    • Brain Diseases
    • Central Nervous System Diseases
    • Nervous System Diseases