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Long-term Extension Study to Assess Adverse Events of Oral Atogepant Tablets in Pediatric Participants (6 to 17 Years of Age) With Migraine
Sponsor: AbbVie
Summary
A migraine is a moderate to severe headache on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. A number of treatments are available for adults with migraine but there are limited approved treatments available for participants less than 18 years of age. The main goal of the study is to evaluate the long-term safety and tolerability of atogepant in pediatric participants between the ages of 6 and 17 with migraine. 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.
Official title: A Multicenter, Open-label, Extension Study to Evaluate the Long-term Safety and Tolerability of Atogepant in Pediatric Subjects 6 to 17 Years of Age With Migraine
Key Details
Gender
All
Age Range
6 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
650
Start Date
2023-06-05
Completion Date
2032-04
Last Updated
2025-08-11
Healthy Volunteers
No
Conditions
Interventions
Atogepant
Oral Tablet
Locations (86)
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