A Long-Term Safety and Tolerability Extension Study Evaluating Atogepant for the Prevention of Chronic or Episodic Migraine
- Conditions
- Episodic MigraineChronic Migraine
- Interventions
- Registration Number
- NCT04686136
- Lead Sponsor
- AbbVie
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 596
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Atogepant 60 mg Atogepant 60 mg Taken once daily
- Primary Outcome Measures
Name Time Method Percentage of Participants with at Least 1 Treatment Emergent Adverse Event 156 weeks
- Secondary Outcome Measures
Name Time Method 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 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)
Percentage of Participants with Clinically Significant Vital Sign Measurements as assessed by the Investigator 156 weeks
Trial Locations
- Locations (116)
Mount Vernon Clinical Research /ID# 226249
🇺🇸Chattanooga, Tennessee, United States
Neuropoint GmbH /ID# 226313
🇩🇪Ulm, Germany
Ottawa Headache Centre Research Inc /ID# 226451
🇨🇦Ottawa, Ontario, Canada
California Headache and Balance Center /ID# 226241
🇺🇸Fresno, California, United States
Clinvest Research LLC /ID# 226275
🇺🇸Springfield, Missouri, United States
Headache Wellness Center /ID# 226233
🇺🇸Greensboro, North Carolina, United States
FORBELI s.r.o. /ID# 228406
🇨🇿Prague, Czechia
Praxis Dr. Gendolla /ID# 229988
🇩🇪Essen, Germany
NeuroMed Zlin s.r.o. /ID# 228414
🇨🇿Zlin, Czechia
Pratia Pardubice a.s. /ID# 226393
🇨🇿Pardubice, Czechia
Puget Sound Neurology /ID# 226253
🇺🇸Tacoma, Washington, United States
StudyMetrix Research /ID# 226296
🇺🇸Saint Peters, Missouri, United States
Abington Neurological Associates - Abington /ID# 226449
🇺🇸Abington, Pennsylvania, United States
NeuroTrials Research Inc /ID# 226477
🇺🇸Atlanta, Georgia, United States
Excell Research, Inc /ID# 228390
🇺🇸Oceanside, California, United States
Schuster Medical Research Institute /ID# 226246
🇺🇸Sherman Oaks, California, United States
Allied Physicians - Fort Wayne Neurological Center /ID# 226390
🇺🇸Fort Wayne, Indiana, United States
Pharmasite Research, Inc. /ID# 226444
🇺🇸Baltimore, Maryland, United States
Alpine Clinical Research Center /ID# 226203
🇺🇸Boulder, Colorado, United States
Sensible Healthcare /ID# 226426
🇺🇸Ocoee, Florida, United States
Texas Neurology /ID# 226425
🇺🇸Dallas, Texas, United States
Aggarwal and Associates Limited /ID# 226452
🇨🇦Brampton, Ontario, Canada
DiscoveResearch, Inc /ID# 226490
🇺🇸Bryan, Texas, United States
NeuroHK s.r.o. /ID# 226429
🇨🇿Hradec Kralove, Czechia
A-Shine s.r.o. /ID# 226207
🇨🇿Plzen, Czechia
Pratia Prague s.r.o. /ID# 226406
🇨🇿Prague, Czechia
CHU Nice - Hopital de Cimiez /ID# 228419
🇫🇷Nice, Alpes-Maritimes, France
Sentara Family Medicine Physicians /ID# 226448
🇺🇸Virginia Beach, Virginia, United States
Ospedale Ss. Filippo e Nicola /ID# 228627
🇮🇹Avezzano, L Aquila, Italy
Hôpital Pierre Wertheimer /ID# 226430
🇫🇷Bron, France
CHU Clermont Ferrand - Hopital Gabriel Montpied /ID# 226459
🇫🇷Clermont Ferrand, France
Samsung Medical Center /ID# 226280
🇰🇷Seoul, Korea, Republic of
Klinische Forschung Hannover-Mitte GmbH /ID# 226305
🇩🇪Hannover, Niedersachsen, Germany
LinQ Research, LLC /ID# 226391
🇺🇸Pearland, Texas, United States
Clinexpert Kft /ID# 228431
🇭🇺Budapest, Hungary
Northwest Clinical Research Center /ID# 226240
🇺🇸Bellevue, Washington, United States
BRAIN-SOULTHERAPY s.r.o. /ID# 226394
🇨🇿Kladno, Czechia
Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 226412
🇵🇱Lublin, Lubelskie, Poland
MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak /ID# 226417
🇵🇱Wroclaw, Poland
INEP medical s.r.o. /ID# 228411
🇨🇿Praha, Czechia
Fondazione Policlinico Universitario Campus Bio-Medico di Roma /ID# 228630
🇮🇹Rome, Roma, Italy
Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord /ID# 228418
🇫🇷St-Priest-en-Jarez, France
CCR Ostrava, s.r.o. /ID# 228412
🇨🇿Ostrava, Czechia
Hospital Universitario Virgen del Rocio /ID# 226333
🇪🇸Sevilla, Spain
Kangbuk Samsung Hospital /ID# 226263
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Schmerzklinik Kiel /ID# 226454
🇩🇪Kiel, Germany
DADO MEDICAL s.r.o. /ID# 226421
🇨🇿Praha, Czechia
AmBeNet GmbH /ID# 226312
🇩🇪Leipzig, Germany
Seoul National University Hospital /ID# 226199
🇰🇷Seoul, Korea, Republic of
Neuropraxis Muenchen Sued /ID# 226309
🇩🇪Unterhaching, Germany
Studienzentrum Nord-West /ID# 226310
🇩🇪Westerstede, Germany
Re:Cognition Health - London /ID# 231205
🇬🇧London, United Kingdom
Centrum Medyczne Pratia Gdynia /ID# 226431
🇵🇱Gdynia, Pomorskie, Poland
S-Medicon Kft /ID# 228432
🇭🇺Budapest, Hungary
Fakultni Thomayerova nemocnice /ID# 228409
🇨🇿Praha, Czechia
Universitaetsklinikum Essen /ID# 229989
🇩🇪Essen, Germany
AP-HM - Hopital de la Timone /ID# 226407
🇫🇷Marseille CEDEX 05, Bouches-du-Rhone, France
Gyongyosi Bugat Pal Korhaz /ID# 228429
🇭🇺Gyongyos, Heves, Hungary
ZorgSaam Zorggroep Zeeuws-Vlaanderen /ID# 226456
🇳🇱Terneuzen, Netherlands
Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 228625
🇮🇹Milano, Italy
Specjalistyczne Gabinety Sp. z o.o. /ID# 228631
🇵🇱Krakow, Malopolskie, Poland
Silmedic Sp. z o.o. /ID# 226457
🇵🇱Katowice, Slaskie, Poland
Pusan National University Hospital /ID# 231416
🇰🇷Busan, Korea, Republic of
Yonsei University Health System Severance Hospital /ID# 226265
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Intermed GmbH /ID# 226307
🇩🇪Wiesbaden, Germany
Canisius-Wilhelmina Ziekenhuis /ID# 226410
🇳🇱Nijmegen, Netherlands
EuroMedis sp. z o.o. /ID# 226413
🇵🇱Szczecin, Zachodniopomorskie, Poland
Universita di Pavia /ID# 228628
🇮🇹Pavia, Italy
Duplicate_CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 226335
🇪🇸Pamplona, Navarra, Spain
Dongtan Sacred Heart Hospital /ID# 226264
🇰🇷Hwaseong, Gyeonggido, Korea, Republic of
King's College Hospital NHS Foundation Trust /ID# 226524
🇬🇧London, United Kingdom
Hospital Clinico Universitario de Valladolid /ID# 226330
🇪🇸Valladolid, Spain
Tri-Service General Hospital /ID# 228998
🇨🇳Taipei City, Taiwan
Hospital Universitario Vall d'Hebron /ID# 226338
🇪🇸Barcelona, Spain
Beth Israel Deaconess Medical Center /ID# 228214
🇺🇸Boston, Massachusetts, United States
Pharmacology Research Institute (PRI) - Newport Beach (Wake) /ID# 226389
🇺🇸Newport Beach, California, United States
Pharmacology Research Institute (PRI) - Los Alamitos (Wake) /ID# 226404
🇺🇸Los Alamitos, California, United States
Methodist Physicians Clinic/CCT Research /ID# 226422
🇺🇸Fremont, Nebraska, United States
Albany Medical Center Rheumatology /ID# 228212
🇺🇸Albany, New York, United States
Duplicate_CTI Clinical Research Center /ID# 226278
🇺🇸Cincinnati, Ohio, United States
CNS Healthcare - Memphis /ID# 226254
🇺🇸Memphis, Tennessee, United States
Clintrial s.r.o. /ID# 228413
🇨🇿Prague 10, Czechia
Vestra Clinics s.r.o. /ID# 226453
🇨🇿Rychnov nad Kneznou, Czechia
AP-HP - Hopital Lariboisière /ID# 226220
🇫🇷Paris, France
Zentrum für Neurologie, Neurochirurgie und Psychiatrie /ID# 229991
🇩🇪Berlin, Germany
Vitos Orthopaedische Klinik Kassel gemeinnuetzige GmbH /ID# 231571
🇩🇪Kassel, Germany
Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 226409
🇭🇺Kaposvár, Somogy, Hungary
IRCCS San Raffaele Pisana /ID# 228436
🇮🇹Rome, Roma, Italy
Azienda Ospedaliero Universitaria Careggi /ID# 228624
🇮🇹Florence, Italy
Nowon Eulji Medical Center, Eulji University /ID# 226261
🇰🇷노원구, Korea, Republic of
Tainan Sin Lau Hospital /ID# 226229
🇨🇳Tainan City, Taiwan
Taipei Veterans General Hospital /ID# 226206
🇨🇳Taipei City, Taipei, Taiwan
Josephson-Wallack-Munshower Neurology - Northeast /ID# 226295
🇺🇸Indianapolis, Indiana, United States
Clinical Research Institute, Inc /ID# 226232
🇺🇸Minneapolis, Minnesota, United States
Stetson-University of Cincinnati /ID# 226326
🇺🇸Cincinnati, Ohio, United States
Collective Medical Research /ID# 226482
🇺🇸Overland Park, Kansas, United States
J. Lewis Research, Inc. / Foothill Family Clinic /ID# 226248
🇺🇸Salt Lake City, Utah, United States
J. Lewis Research, Inc. Foothill Family Clinic South /ID# 226328
🇺🇸Salt Lake City, Utah, United States
Highland Clinical Research /ID# 226287
🇺🇸Salt Lake City, Utah, United States
Rigshospitalet Glostrup /ID# 228417
🇩🇰Glostrup, Hovedstaden, Denmark
BTC of New Bedford /ID# 226289
🇺🇸New Bedford, Massachusetts, United States
Albuquerque Clinical Trials, Inc /ID# 226523
🇺🇸Albuquerque, New Mexico, United States
Preferred Primary Care Physicians, Inc. /ID# 226447
🇺🇸Pittsburgh, Pennsylvania, United States
Diex Recherche Sherbrooke Inc. /ID# 226427
🇨🇦Sherbrooke, Quebec, Canada
Kuang-Tien General Hospital /ID# 226259
🇨🇳Taichung City, Taiwan
Ochsner Clinic Foundation /ID# 228220
🇺🇸Covington, Louisiana, United States
Vancouver Island Health Authority /ID# 226255
🇨🇦Victoria, British Columbia, Canada
Centrum Leczenia Padaczki i Migreny /ID# 226458
🇵🇱Krakow, Malopolskie, Poland
Solumed Centrum Medyczne /ID# 226298
🇵🇱Poznan, Wielkopolskie, Poland
Headache Neurology Research Institute /ID# 226234
🇺🇸Ridgeland, Mississippi, United States
Barrow Neurological Institute /ID# 228217
🇺🇸Phoenix, Arizona, United States
Vitamed Galaj i Cichomski Sp.j. /ID# 226416
🇵🇱Bydgoszcz, Kujawsko-pomorskie, Poland
CHAMP Clinic /ID# 226256
🇨🇦Calgary, Alberta, Canada
Accel Research Sites - Tampa Clinical Research Unit /ID# 226252
🇺🇸Tampa, Florida, United States
FutureSearch Trials of Neurology /ID# 226424
🇺🇸Austin, Texas, United States
Austin Clinical Trial Partners /ID# 228391
🇺🇸Austin, Texas, United States