TEMPLE
Research type
Research Study
Full title
A Randomized, Double-blind, Parallel-group, Active Controlled Trial with Open-label Safety Extension to Evaluate the Tolerability, Safety, and Efficacy of Atogepant versus Topiramate in Subjects Requiring Preventive Treatment of Migraine (TEMPLE)
IRAS ID
1007024
Contact name
Alice Butler
Contact email
Sponsor organisation
AbbVie Deutschland GmbH & Co. KG
Eudract number
2022-000761-41
Research summary
Migraine is a common neurological disorder typically characterized by attacks of throbbing, moderate to severe headache, often associated with nausea, vomiting, and sensitivity to light and sound. Migraine is extremely common and disabling in children. The purpose of this study is to evaluate how safe and effective atogepant is versus topiramate in adult participants with migraine. Adverse events and change in migraine days will be assessed. Atogepant is an approved drug in the United States for the preventive treatment of episodic migraine in adults. This study is conducted in 2 periods. In double-blind period, participants will be randomly assigned to one of the 2 treatment groups and receive atogepant or topiramate. In open-label period, all participants will receive atogepant. Approximately 520 adult participants will be enrolled in this study in approximately 85 sites across the world. Participants will receive oral atogepant or matching placebo tablets or oral topiramate or matching placebo capsules daily for 24 weeks in double-blind period. In open-label period, all participants will receive oral atogepant tablets daily for 52 weeks and will be followed for 4 weeks.
REC name
East of England - Essex Research Ethics Committee
REC reference
23/EE/0025
Date of REC Opinion
6 Oct 2023
REC opinion
Further Information Favourable Opinion