Clinical trial NCT04686136: A Long-Term Safety and Tolerability Extension Study Evaluating Atogepant for the Prevention of Chronic or Episodic Migraine
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Episodic Migraine
Chronic Migraine
Keywords: Episodic migraine
Chronic migraine
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2020-12-28
Enrollment: 596
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants with at Least 1 Treatment Emergent Adverse Event
timeFrame: 156 weeks
Secondary outcomes:
measure: Percentage of Participants with Clinically Significant Laboratory Values (Chemistry, Hematology, Urinalysis) as assessed by the Investigator
timeFrame: 156 weeks
measure: Percentage of Participants with Clinically Significant Electrocardiograms (ECGs) Findings as assessed by the Investigator
timeFrame: 156 weeks
measure: Percentage of Participants with Clinically Significant Vital Sign Measurements as assessed by the Investigator
timeFrame: 156 weeks
measure: Columbia-Suicide Severity Rating Scale (C-SSRS) Assessing Suicidal Ideation and Behaviour using 5-Point Scales
timeFrame: 156 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barrow Neurological Institute /ID# 228217
state: Arizona
city: Fresno
country: United States
facility: California Headache and Balance Center /ID# 226241
state: California
city: Los Alamitos
country: United States
facility: Pharmacology Research Institute (PRI) - Los Alamitos (Wake) /ID# 226404
state: California
city: Newport Beach
country: United States
facility: Pharmacology Research Institute (PRI) - Newport Beach (Wake) /ID# 226389
state: California
city: Oceanside
country: United States
facility: Excell Research, Inc /ID# 228390
state: California
city: Sherman Oaks
country: United States
facility: Schuster Medical Research Institute /ID# 226246
state: California
city: Boulder
country: United States
facility: Alpine Clinical Research Center /ID# 226203
state: Colorado
city: Ocoee
country: United States
facility: Sensible Healthcare /ID# 226426
state: Florida
city: Tampa
country: United States
facility: Accel Research Sites - Tampa Clinical Research Unit /ID# 226252
state: Florida
city: Atlanta
country: United States
facility: NeuroTrials Research Inc /ID# 226477
state: Georgia
city: Fort Wayne
country: United States
facility: Allied Physicians - Fort Wayne Neurological Center /ID# 226390
state: Indiana
city: Indianapolis
country: United States
facility: Josephson-Wallack-Munshower Neurology - Northeast /ID# 226295
state: Indiana
city: Overland Park
country: United States
facility: Collective Medical Research /ID# 226482
state: Kansas
city: Covington
country: United States
facility: Ochsner Clinic Foundation /ID# 228220
state: Louisiana
city: Baltimore
country: United States
facility: Pharmasite Research, Inc. /ID# 226444
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center /ID# 228214
state: Massachusetts
city: New Bedford
country: United States
facility: BTC of New Bedford /ID# 226289
state: Massachusetts
city: Minneapolis
country: United States
facility: Clinical Research Institute, Inc /ID# 226232
state: Minnesota
city: Ridgeland
country: United States
facility: Headache Neurology Research Institute /ID# 226234
state: Mississippi
city: Saint Peters
country: United States
facility: StudyMetrix Research /ID# 226296
state: Missouri
city: Springfield
country: United States
facility: Clinvest Research LLC /ID# 226275
state: Missouri
city: Fremont
country: United States
facility: Methodist Physicians Clinic/CCT Research /ID# 226422
state: Nebraska
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials, Inc /ID# 226523
state: New Mexico
city: Albany
country: United States
facility: Albany Medical Center Rheumatology /ID# 228212
state: New York
city: Greensboro
country: United States
facility: Headache Wellness Center /ID# 226233
state: North Carolina
city: Cincinnati
country: United States
facility: Duplicate_CTI Clinical Research Center /ID# 226278
state: Ohio
city: Cincinnati
country: United States
facility: Stetson-University of Cincinnati /ID# 226326
state: Ohio
city: Abington
country: United States
facility: Abington Neurological Associates - Abington /ID# 226449
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Preferred Primary Care Physicians, Inc. /ID# 226447
state: Pennsylvania
city: Chattanooga
country: United States
facility: Mount Vernon Clinical Research /ID# 226249
state: Tennessee
city: Memphis
country: United States
facility: CNS Healthcare - Memphis /ID# 226254
state: Tennessee
city: Austin
country: United States
facility: FutureSearch Trials of Neurology /ID# 226424
state: Texas
city: Austin
country: United States
facility: Austin Clinical Trial Partners /ID# 228391
state: Texas
city: Bryan
country: United States
facility: DiscoveResearch, Inc /ID# 226490
state: Texas
city: Dallas
country: United States
facility: Texas Neurology /ID# 226425
state: Texas
city: Pearland
country: United States
facility: LinQ Research, LLC /ID# 226391
state: Texas
city: Salt Lake City
country: United States
facility: J. Lewis Research, Inc. / Foothill Family Clinic /ID# 226248
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research, Inc. Foothill Family Clinic South /ID# 226328
state: Utah
city: Salt Lake City
country: United States
facility: Highland Clinical Research /ID# 226287
state: Utah
city: Virginia Beach
country: United States
facility: Sentara Family Medicine Physicians /ID# 226448
state: Virginia
city: Bellevue
country: United States
facility: Northwest Clinical Research Center /ID# 226240
state: Washington
city: Tacoma
country: United States
facility: Puget Sound Neurology /ID# 226253
state: Washington
city: Calgary
country: Canada
facility: CHAMP Clinic /ID# 226256
state: Alberta
city: Victoria
country: Canada
facility: Vancouver Island Health Authority /ID# 226255
state: British Columbia
city: Brampton
country: Canada
facility: Aggarwal and Associates Limited /ID# 226452
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Headache Centre Research Inc /ID# 226451
state: Ontario
city: Sherbrooke
country: Canada
facility: Diex Recherche Sherbrooke Inc. /ID# 226427
state: Quebec
city: Hradec Kralove
country: Czechia
facility: NeuroHK s.r.o. /ID# 226429
city: Kladno
country: Czechia
facility: BRAIN-SOULTHERAPY s.r.o. /ID# 226394
city: Ostrava
country: Czechia
facility: CCR Ostrava, s.r.o. /ID# 228412
city: Pardubice
country: Czechia
facility: Pratia Pardubice a.s. /ID# 226393
city: Plzen
country: Czechia
facility: A-Shine s.r.o. /ID# 226207
city: Prague 10
country: Czechia
facility: Clintrial s.r.o. /ID# 228413
city: Prague
country: Czechia
facility: Pratia Prague s.r.o. /ID# 226406
city: Prague
country: Czechia
facility: FORBELI s.r.o. /ID# 228406
city: Praha
country: Czechia
facility: DADO MEDICAL s.r.o. /ID# 226421
city: Praha
country: Czechia
facility: Fakultni Thomayerova nemocnice /ID# 228409
city: Praha
country: Czechia
facility: INEP medical s.r.o. /ID# 228411
city: Rychnov nad Kneznou
country: Czechia
facility: Vestra Clinics s.r.o. /ID# 226453
city: Zlin
country: Czechia
facility: NeuroMed Zlin s.r.o. /ID# 228414
city: Glostrup
country: Denmark
facility: Rigshospitalet Glostrup /ID# 228417
state: Hovedstaden
city: Nice
country: France
facility: CHU Nice - Hopital de Cimiez /ID# 228419
state: Alpes-Maritimes
city: Marseille CEDEX 05
country: France
facility: AP-HM - Hopital de la Timone /ID# 226407
state: Bouches-du-Rhone
city: Bron
country: France
facility: Hôpital Pierre Wertheimer /ID# 226430
city: Clermont Ferrand
country: France
facility: CHU Clermont Ferrand - Hopital Gabriel Montpied /ID# 226459
city: Paris
country: France
facility: AP-HP - Hopital Lariboisière /ID# 226220
city: St-Priest-en-Jarez
country: France
facility: Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord /ID# 228418
city: Hannover
country: Germany
facility: Klinische Forschung Hannover-Mitte GmbH /ID# 226305
state: Niedersachsen
city: Berlin
country: Germany
facility: Zentrum für Neurologie, Neurochirurgie und Psychiatrie /ID# 229991
city: Essen
country: Germany
facility: Praxis Dr. Gendolla /ID# 229988
city: Essen
country: Germany
facility: Universitaetsklinikum Essen /ID# 229989
city: Kassel
country: Germany
facility: Vitos Orthopaedische Klinik Kassel gemeinnuetzige GmbH /ID# 231571
city: Kiel
country: Germany
facility: Schmerzklinik Kiel /ID# 226454
city: Leipzig
country: Germany
facility: AmBeNet GmbH /ID# 226312
city: Ulm
country: Germany
facility: Neuropoint GmbH /ID# 226313
city: Unterhaching
country: Germany
facility: Neuropraxis Muenchen Sued /ID# 226309
city: Westerstede
country: Germany
facility: Studienzentrum Nord-West /ID# 226310
city: Wiesbaden
country: Germany
facility: Intermed GmbH /ID# 226307
city: Gyongyos
country: Hungary
facility: Gyongyosi Bugat Pal Korhaz /ID# 228429
state: Heves
city: Kaposvár
country: Hungary
facility: Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 226409
state: Somogy
city: Budapest
country: Hungary
facility: Clinexpert Kft /ID# 228431
city: Budapest
country: Hungary
facility: S-Medicon Kft /ID# 228432
city: Avezzano
country: Italy
facility: Ospedale Ss. Filippo e Nicola /ID# 228627
state: L Aquila
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Campus Bio-Medico di Roma /ID# 228630
state: Roma
city: Rome
country: Italy
facility: IRCCS San Raffaele Pisana /ID# 228436
state: Roma
city: Florence
country: Italy
facility: Azienda Ospedaliero Universitaria Careggi /ID# 228624
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 228625
city: Pavia
country: Italy
facility: Universita di Pavia /ID# 228628
city: Hwaseong
country: Korea, Republic of
facility: Dongtan Sacred Heart Hospital /ID# 226264
state: Gyeonggido
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital /ID# 226263
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System Severance Hospital /ID# 226265
state: Seoul Teugbyeolsi
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital /ID# 231416
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital /ID# 226199
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center /ID# 226280
city: 노원구
country: Korea, Republic of
facility: Nowon Eulji Medical Center, Eulji University /ID# 226261
city: Nijmegen
country: Netherlands
facility: Canisius-Wilhelmina Ziekenhuis /ID# 226410
city: Terneuzen
country: Netherlands
facility: ZorgSaam Zorggroep Zeeuws-Vlaanderen /ID# 226456
city: Bydgoszcz
country: Poland
facility: Vitamed Galaj i Cichomski Sp.j. /ID# 226416
state: Kujawsko-pomorskie
city: Lublin
country: Poland
facility: Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 226412
state: Lubelskie
city: Krakow
country: Poland
facility: Specjalistyczne Gabinety Sp. z o.o. /ID# 228631
state: Malopolskie
city: Krakow
country: Poland
facility: Centrum Leczenia Padaczki i Migreny /ID# 226458
state: Malopolskie
city: Gdynia
country: Poland
facility: Centrum Medyczne Pratia Gdynia /ID# 226431
state: Pomorskie
city: Katowice
country: Poland
facility: Silmedic Sp. z o.o. /ID# 226457
state: Slaskie
city: Poznan
country: Poland
facility: Solumed Centrum Medyczne /ID# 226298
state: Wielkopolskie
city: Szczecin
country: Poland
facility: EuroMedis sp. z o.o. /ID# 226413
state: Zachodniopomorskie
city: Wroclaw
country: Poland
facility: MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak /ID# 226417
city: Pamplona
country: Spain
facility: Duplicate_CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 226335
state: Navarra
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron /ID# 226338
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio /ID# 226333
city: Valladolid
country: Spain
facility: Hospital Clinico Universitario de Valladolid /ID# 226330
city: Taipei City
country: Taiwan
facility: Taipei Veterans General Hospital /ID# 226206
state: Taipei
city: Taichung City
country: Taiwan
facility: Kuang-Tien General Hospital /ID# 226259
city: Tainan City
country: Taiwan
facility: Tainan Sin Lau Hospital /ID# 226229
city: Taipei City
country: Taiwan
facility: Tri-Service General Hospital /ID# 228998
city: London
country: United Kingdom
facility: King's College Hospital NHS Foundation Trust /ID# 226524
city: London
country: United Kingdom
facility: Re:Cognition Health - London /ID# 231205
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: