M21-199 Extension - Atogepant for the Treatment of Pediatric Subjects with Episodic Migraine
Research type
Research Study
Full title
A Multicenter, Open-label, Extension Study to Evaluate the Long-term Safety of Atogepant in Pediatric Subjects 6 to 17 Years of Age with Episodic Migraine
IRAS ID
1007410
Contact name
Elma Stephen
Contact email
Sponsor organisation
AbbVie Deutschland GmbH & Co. KG
Eudract number
2022-501099-24
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
Research 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 episodic migraine.
Atogepant is a medicine currently approved to treat adults with episodic 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 episodic migraine. This is a Phase 3, open-label study of atogepant in participants with a history of episodic migraine. Participants must have completed participation in another study of atogepant (lead-in study) or completed the screening period of that study. Participants must have 4 to 14 migraine days and less than 15 headache days in the 4-week screening electronic diary (eDiary; similar to a smart phone). Around 250 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.REC name
East of England - Cambridge South Research Ethics Committee
REC reference
23/EE/0119
Date of REC Opinion
22 Sep 2023
REC opinion
Further Information Favourable Opinion