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A Study of Oral Atogepant Tablets to Assess Adverse Events and Change in Disease Activity To Prevent Migraine in Participants Aged 12 to 17 Years
Sponsor: AbbVie
Summary
Migraine is a disease that most often causes 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. The goals of the study are to evaluate adverse events and how well treatment of atogepant works compared to placebo (looks like the study treatment but contains no medicine) in preventing chronic migraine in participants between 12 and 17 years of age. Atogepant is a medicine currently approved in the United States and Europe for the preventive treatment of migraine in adult patients with migraine and is being studied for the preventative treatment of chronic migraine in participants between the ages of 12 and 17 years. Participants will be randomly assigned to one of the 2 groups to be treated with either atogepant or placebo. This study is double-blinded, which means that neither the patients nor the study doctors know who is given which study treatment. Approximately 420 participants 12 to 17 years of age with chronic migraine will be enrolled at approximately 70 sites across the world. Participants will receive oral tablets of atogepant or placebo once daily for 12 weeks and will be followed for 4 weeks. Participants will attend regular visits during the study at a hospital or clinic and the effects of treatment will be checked by completion of a daily diary, medical assessments, blood tests, checking for side effects, and completing questionnaires.
Official title: A Phase 3, Multicenter, 12-Week, Double Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Atogepant for the Preventive Treatment of Chronic Migraine in Pediatric Subjects 12 to 17 Years of Age
Key Details
Gender
All
Age Range
12 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
420
Start Date
2025-02-13
Completion Date
2031-03
Last Updated
2026-04-06
Healthy Volunteers
No
Conditions
Interventions
Atogepant
Oral tablet
Placebo for Atogepant
Oral tablet
Locations (59)
Rehabilitation & Neurological Services /ID# 270782
Huntsville, Alabama, United States
Preferred Research Partner, Inc /ID# 270389
Little Rock, Arkansas, United States
Preferred Research Partners /ID# 270419
Little Rock, Arkansas, United States
Advanced Research Center /ID# 270257
Anaheim, California, United States
Neuro Pain Research Center /ID# 271048
Fresno, California, United States
Accellacare - Long Beach /ID# 270398
Long Beach, California, United States
Excell Research /ID# 270258
Oceanside, California, United States
Lumos Clinical Research Center /ID# 270582
San Jose, California, United States
Sunwise Clinical Research /ID# 270431
Walnut Creek, California, United States
Northwest Florida Clinical Research Group, LLC /ID# 270833
Gulf Breeze, Florida, United States
Auzmer Research /ID# 271158
Lakeland, Florida, United States
My Preferred Research /ID# 270312
Miami, Florida, United States
Encore Medical Research - Weston /ID# 271139
Weston, Florida, United States
Pediatric Neurology & Epilepsy Center Of Central Florida - Winter Park /ID# 275263
Winter Park, Florida, United States
Deaconess Midtown Hospital /ID# 270572
Evansville, Indiana, United States
Michigan Headache & Neurological Institute /ID# 270942
Ann Arbor, Michigan, United States
Proven Endpoints LLC /ID# 270269
Ridgeland, Mississippi, United States
Cct Research - Papillion Research Center /ID# 270393
Papillion, Nebraska, United States
Healthy Perspectives - Innovate Mental Health Services /ID# 270847
Nashua, New Hampshire, United States
Dent Neurologic Institute - Amherst /ID# 270260
Amherst, New York, United States
Headache Wellness Center /ID# 270568
Greensboro, North Carolina, United States
Frontier Clinical Research - Scottdale /ID# 270854
Scottdale, Pennsylvania, United States
Frontier Clinical Research - Smithfield /ID# 270849
Smithfield, Pennsylvania, United States
Access Clinical Trials Inc /ID# 270280
Nashville, Tennessee, United States
UT Health Austin at Dell Childrens Neurology Clinic /ID# 270577
Austin, Texas, United States
Earle Research /ID# 270424
Houston, Texas, United States
Clinpoint Trials /ID# 270261
Waxahachie, Texas, United States
Pantheon Clinical Research /ID# 270259
Bountiful, Utah, United States
Alpine Research Organization - Clinton /ID# 276527
Clinton, Utah, United States
Highland Clinical Research /ID# 270281
Salt Lake City, Utah, United States
Frontier Clinical Research - Kingwood /ID# 271053
Kingwood, West Virginia, United States
London Health Sciences Centre - Victoria Hospital & Children's Hospital /ID# 270659
London, Ontario, Canada
McGill University Health Centre - Glen Site. /ID# 270662
Montreal, Quebec, Canada
Herlev Hospital /ID# 270482
Herlev, Capital Region, Denmark
Regionshospitalet Godstrup /ID# 270481
Herning, Central Jutland, Denmark
Semmelweis Egyetem /ID# 271219
Budapest, Hungary
Rozsavolgyi Rendelo-Ceba Bt. /ID# 271500
Budapest, Hungary
Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 270756
Milan, Milano, Italy
Ospedale Pediatrico Bambino Gesù /ID# 270759
Rome, Roma, Italy
Konan Medical Center /ID# 270486
Kobe, Hyōgo, Japan
Umenotsuji Clinic /ID# 270484
Kochi, Kochi, Japan
Tominaga Clinic - Osaka /ID# 270483
Osaka, Osaka, Japan
Tokyo Headache Clinic /ID# 271610
Shibuya-ku, Tokyo, Japan
Tokyo Medical University Hospital /ID# 270487
Shinjuku-ku, Tokyo, Japan
Tendo Brain Clinic /ID# 271410
Tendo-shi, Yamagata, Japan
Nagaseki Headache Clinic /ID# 271699
Kai, Yamanashi, Japan
Tanaka Neurosurgery & Headache Clinic /ID# 271346
Kagoshima, Japan
Canisius-Wilhelmina Ziekenhuis /ID# 270374
Nijmegen, Gelderland, Netherlands
HagaZiekenhuis /ID# 270379
The Hague, South Holland, Netherlands
Clinical Research Center Medic-R /ID# 270235
Poznan, Greater Poland Voivodeship, Poland
Athleticomed Sp. z o.o /ID# 270243
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Specjalistyczne Gabinety Sp. z o.o /ID# 270238
Krakow, Lesser Poland Voivodeship, Poland
MIGRE Polskie Centrum Leczenia Migreny /ID# 270239
Wroclaw, Lower Silesian Voivodeship, Poland
Oha-Med Sp. Z O.O /ID# 270242
Warsaw, Masovian Voivodeship, Poland
Hospital da Luz /ID# 277991
Lisbon, Lisbon District, Portugal
CMRC Headlands LLC /ID# 271300
San Juan, Puerto Rico
Medway Maritime Hospital /ID# 271885
Gillingham, Kent, United Kingdom
Royal Aberdeen Children's Hospital /ID# 271664
Aberdeen, Scotland, United Kingdom
Stepping Hill Hospital-Stockport NHS foundation trust /ID# 271883
Stockport, United Kingdom