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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
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.
Age
12 - 17 years
Sex
ALL
Healthy Volunteers
No
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
Start Date
February 13, 2025
Primary Completion Date
March 1, 2031
Completion Date
March 1, 2031
Last Updated
February 12, 2026
420
ESTIMATED participants
Atogepant
DRUG
Placebo for Atogepant
DRUG
Lead Sponsor
AbbVie
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05337033