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

Chronic Migraine Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04686136
• Other study ID #: 3101-312-002
• Secondary ID: 2020-002470-27
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: February 19, 2021
• Est. completion date: October 8, 2025

Study information

• Verified date: April 2024
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 596
• Est. completion date: October 8, 2025
• Est. primary completion date: October 8, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Migraine
• Episodic Migraine
• Migraine Disorders

Intervention

Drug:
• Atogepant 60 mg
Tablets containing 60 mg of Atogepant

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Canada,  Czechia,  Denmark,  France,  Germany,  Hungary,  Italy,  Korea, Republic of,  Netherlands,  Poland,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants with at Least 1 Treatment Emergent Adverse Event		156 weeks
Secondary	Percentage of Participants with Clinically Significant Laboratory Values (Chemistry, Hematology, Urinalysis) as assessed by the Investigator		156 weeks
Secondary	Percentage of Participants with Clinically Significant Electrocardiograms (ECGs) Findings as assessed by the Investigator		156 weeks
Secondary	Percentage of Participants with Clinically Significant Vital Sign Measurements as assessed by the Investigator		156 weeks
Secondary	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)	156 weeks

External Links

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