Long-term Extension Study to Assess Adverse Events of Oral Atogepant Tablets in Pediatric Participants (6 to 17 Years of Age) With Migraine
NCT ID: NCT05707949
Last Updated: 2025-08-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
PHASE3
650 participants
INTERVENTIONAL
2023-06-05
2032-04-30
Brief Summary
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Atogepant is a medicine currently approved to treat adults with migraine (0 to 14 migraine days per month) and is being studied in pediatric participants between the ages of 6 and 17 with a history of migraine. This is a Phase 3, open-label study of atogepant in participants with a history of migraine. Participants must have completed participation in another study of atogepant (lead-in study). Participants must have 4 to 14 migraine days and less than 15 headache days for episodic migraine, and \>= 15 headache days and \>= 8 migraine days for chronic migraine in the 4-week screening electronic diary (eDiary; similar to a smart phone). Around 650 participants will be enrolled in the study at approximately 100 sites worldwide.
Atogepant is a tablet taken once a day by mouth. Participants between the ages of 12 and 17 will receive high dose atogepant for 52 Weeks. Participants between the ages of 6 and 11 will receive an atogepant dose determined in the lead-in study for 52 Weeks.
There may be a bigger responsibility for participants in this study. Participants will attend regular visits during the study at a hospital or clinic. The effects of treatment will be checked by medical assessments, blood tests, checking for side effects, and completing questionnaires.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Atogepant Dose A (12-17 yrs)
Participant aged 12-17 will receive oral tablets of atogepant Dose A once a day for up to 52 weeks.
Atogepant
Oral Tablet
Atogepant Dose B (6-11 yrs)
Participants aged 6-11 will receive the highest dose of oral tablets of atogepant tested in the lead-in study M21-201.
Atogepant
Oral Tablet
Interventions
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Atogepant
Oral Tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The participant must have completed the lead-in Study M21-201, or the pharmacokinetic (PK) substudy in Study M21-201, or the lead-in Study M23-712.
* Weight is \>= 20 kg (44 lbs) and \< 135 kg (298 lbs).
* A history of migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3; 2018) for at least 6 months.
Exclusion Criteria
* Have any clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, cardiovascular, or neurologic disease.
6 Years
17 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Rehabilitation & Neurological Services /ID# 250910
Huntsville, Alabama, United States
Preferred Research Partners /ID# 250937
Little Rock, Arkansas, United States
Advanced Research Center /ID# 251616
Anaheim, California, United States
Sunwise Clinical Research /ID# 250913
Lafayette, California, United States
Alliance for Research Alliance for Wellness /ID# 250911
Long Beach, California, United States
Excell Research, Inc /ID# 251611
Oceanside, California, United States
Lumos Clinical Research Center /ID# 251608
San Jose, California, United States
Advanced Neurosciences Research, LLC /ID# 250925
Fort Collins, Colorado, United States
Northwest Florida Clinical Research Group, LLC /ID# 251614
Gulf Breeze, Florida, United States
Advanced Research Institute of Miami /ID# 250916
Homestead, Florida, United States
My Preferred Research LLC /ID# 250931
Miami, Florida, United States
Asclepes Research Centers - Spring Hill /ID# 250912
Spring Hill, Florida, United States
Coastal Georgia Child Neurology /ID# 250938
Brunswick, Georgia, United States
Deaconess Clinic - Gateway Health Center /ID# 250923
Newburgh, Indiana, United States
College Park Family Care Center Overland Park /ID# 251609
Overland Park, Kansas, United States
Michigan Headache & Neurological Institute (MHNI) /ID# 250920
Ann Arbor, Michigan, United States
Proven Endpoints LLC /ID# 258083
Ridgeland, Mississippi, United States
Cognitive Clinical Trials (CCT) - Papillion /ID# 251610
Papillion, Nebraska, United States
Goryeb Children's Hospital /ID# 250934
Morristown, New Jersey, United States
Dent Neurosciences Research Center, Inc. /ID# 250915
Amherst, New York, United States
Modern Migraine MD /ID# 258082
New York, New York, United States
Headache Wellness Center /ID# 251612
Greensboro, North Carolina, United States
Patient Priority Clinical Sites, LLC /ID# 250922
Cincinnati, Ohio, United States
CincyScience /ID# 250935
West Chester, Ohio, United States
Lynn Institute of Oklahoma City /ID# 250926
Oklahoma City, Oklahoma, United States
Access Clinical Trials, Inc. /ID# 250914
Nashville, Tennessee, United States
FutureSearch Trials of Neurology /ID# 251613
Austin, Texas, United States
3A Research - East El Paso /ID# 250909
El Paso, Texas, United States
Earle Research /ID# 250908
Friendswood, Texas, United States
Family Psychiatry of The Woodlands /ID# 250936
The Woodlands, Texas, United States
ClinPoint Trials /ID# 250942
Waxahachie, Texas, United States
Pantheon Clinical Research /ID# 251615
Bountiful, Utah, United States
Highland Clinical Research /ID# 250924
Salt Lake City, Utah, United States
Office of Maria Ona /ID# 250939
Franklin, Virginia, United States
Core Clinical Research /ID# 250932
Everett, Washington, United States
Uza /Id# 247885
Edegem, Antwerpen, Belgium
AZ Sint-Jan Brugge /ID# 247527
Bruges, , Belgium
Stollery Children's Hospital /ID# 251426
Edmonton, Alberta, Canada
Montreal Children's Hospital /ID# 250649
Montreal, Quebec, Canada
Herlev Hospital /ID# 247725
Herlev, Capital Region, Denmark
Regionshospitalet Godstrup /ID# 247903
Herning, Central Jutland, Denmark
Aalborg Universitetshospital /Id# 247429
Aalborg, North Denmark, Denmark
CHU Amiens-Picardie Site Sud /ID# 251377
Amiens, Somme, France
Centre Hosp Intercommunal de Creteil /ID# 251199
Créteil, Val-de-Marne, France
CHU Toulouse - Hôpital des enfants /ID# 251201
Toulouse, , France
Semmelweis Egyetem /ID# 251593
Budapest, Budapest, Hungary
Mind Klinika Kft. /ID# 251597
Budapest, , Hungary
Shamir Medical Center /ID# 256858
Beer Ya'akov, Central District, Israel
Hillel Yaffe Medical Center /ID# 248923
Hadera, H_efa, Israel
Bnai Zion Medical Center /ID# 251132
Haifa, H_efa, Israel
The Chaim Sheba Medical Center /ID# 248990
Ramat Gan, Tel Aviv, Israel
Tel Aviv Sourasky Medical Center /ID# 251133
Tel Aviv, Tel Aviv, Israel
Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 249182
Milan, Milano, Italy
Azienda Ospedaliera Universitaria Paolo Giaccone /ID# 249184
Palermo, Palermo, Italy
Konan Medical Center /ID# 254458
Kobe, Hyōgo, Japan
Yamaguchi Clinic /ID# 254763
Nishinomiya-shi, Hyōgo, Japan
Umenotsuji Clinic /ID# 254454
Kochi, Kochi, Japan
Sendai Headache and Neurology Clinic Medical Corporation /ID# 254212
Sendai, Miyagi, Japan
Tominaga Clinic /ID# 254451
Osaka, Osaka, Japan
Tokyo Medical University Hospital /ID# 254460
Shinjuku-ku, Tokyo, Japan
Tatsuoka Neurology Clinic /ID# 254456
Kyoto, , Japan
Canisius-Wilhelmina Ziekenhuis /ID# 253067
Nijmegen, , Netherlands
ZorgSaam Zorggroep Zeeuws-Vlaanderen /ID# 250603
Terneuzen, , Netherlands
HagaZiekenhuis /ID# 251655
The Hague, , Netherlands
Clinical Research Center Sp. z.o.o. Medic-R sp. k /ID# 250623
Poznan, Greater Poland Voivodeship, Poland
Athleticomed Sp. z o.o /ID# 250620
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Specjalistyczne Gabinety Sp. z o.o. /ID# 250625
Krakow, Lesser Poland Voivodeship, Poland
Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 250622
Lublin, Lublin Voivodeship, Poland
OHA-MED sp. z o.o /ID# 250621
Warsaw, Masovian Voivodeship, Poland
MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak /ID# 250624
Wroclaw, , Poland
Clinical Research Investigator Group, LLC /ID# 261251
Bayamón, Puerto Rico, Puerto Rico
Dr. Samuel Sanchez PSC /ID# 261670
Caguas, Puerto Rico, Puerto Rico
Puerto Rico Health Institute /ID# 250949
Dorado, Puerto Rico, Puerto Rico
Caribbean Medical Research Center /ID# 253156
San Juan, Puerto Rico, Puerto Rico
PRCCI Clinical Research Center /ID# 264232
San Juan, Puerto Rico, Puerto Rico
Spitalul Clinic de Copii Dr. Victor Gomoiu /ID# 250997
Bucharest, București, Romania
Spitalul Clinic de Urgenta pentru Copii Cluj Napoca /ID# 251112
Cluj-Napoca, Cluj, Romania
Delta Health Care S.R.L /ID# 250996
Bucharest, , Romania
Hospital Universitario Vall d'Hebron /ID# 248457
Barcelona, Barcelona, Spain
Hospital Clinico San Carlos /ID# 249268
Madrid, Madrid, Spain
Hospital Universitario Virgen del Rocio /ID# 248633
Seville, Sevilla, Spain
Hospital Universitario y Politecnico La Fe /ID# 248459
Valencia, Valencia, Spain
Vastra Gotealandsregionen Regionhalsan /ID# 248981
Mölnlycke, , Sweden
Sodersjukhuset /ID# 250671
Stockholm, , Sweden
NHS Grampian /ID# 251474
Aberdeen, , United Kingdom
Stockport NHS foundation trust /ID# 261562
Stockport, , United Kingdom
Countries
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Related Links
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Other Identifiers
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2022-501099-24-00
Identifier Type: OTHER
Identifier Source: secondary_id
M21-199
Identifier Type: -
Identifier Source: org_study_id
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