Efficacy, Safety, and Tolerability of Multiple Dosing Regimens of Oral Atogepant (AGN-241689) in Episodic Migraine Prevention

This study will evaluate the safety and tolerability of the following doses of atogepant (AGN-241689): 10 mg once daily (QD), 30 mg QD, 30 mg twice daily (BID), 60 mg QD, and 60 mg BID for the prevention of episodic migraine and will characterize the dose/response relationship.


Study Type: Interventional  (Clinical Trial)
Actual Enrollment: 834 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel-Group Study To Evaluate The Efficacy, Safety, And Tolerability Of Multiple Dosing Regimens Of Oral AGN-241689 In Episodic Migraine Prevention
Actual Study Start Date: September 6, 2016
Actual Primary Completion Date: April 2, 2018
Actual Study Completion Date: April 23, 2018

Arms:
- Placebo Comparator: Placebo
- Experimental: Atogepant 10 mg QD
- Experimental: Atogepant 30 mg QD
- Experimental: Atogepant 30 mg BID
- Experimental: Atogepant 60 mg QD
- Experimental: Atogepant 60 mg BID