M23-712 - Ph3 Paediatric Chronic migraine
Research type
Research Study
Full 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
IRAS ID
1011032
Contact name
Bernhard Dodell
Contact email
Sponsor organisation
AbbVie Deutschland GmbH & Co. KG
Eudract number
2024-513836-28
Research summary
Lay Summary approved by Trial Disclosures team.
To evaluate the safety and efficacy of Atogepant when administered daily for the preventive treatment of chronic migraine in pediatric subjects 12 to 17 years of age.
Primary Efficacy Endpoint:
• Change from baseline in mean monthly migraine days across the 12-week treatment period.
The secondary efficacy objective of the study is to evaluate the efficacy of preventive treatment with Atogepant when compared to placebo with respect to the secondary endpoints in pediatric subjects 12 to 17 years of age with chronic migraine.
Change from baseline in mean monthly headache days across the 12-week treatment period.
• Change from baseline in mean monthly acute medication use days across the 12-week treatment period.
• Achievement of at least a 50% reduction in 3-month average of monthly migraine days.
• Change from baseline in the Pediatric Quality of Life Inventory (PedsQL) total score at Week 12.
• Change from baseline on the Pediatric Migraine Disability Assessment (PedMIDAS) total score at Week 12.
Atogepant is a potent, selective oral calcitonin gene-related peptide receptor antagonist approved in several countries worldwide, including the United States and Europe for preventive treatment of chronic migraine in adults at 60 mg QD. This 12-week, double-blind, placebo-
controlled Phase 3 study will assess the safety and efficacy of Atogepant in pediatric subjects with chronic migraine aged 12 to 17 years.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
25/NE/0040
Date of REC Opinion
14 Apr 2025
REC opinion
Further Information Favourable Opinion