Effectiveness, Safety, and Tolerability of Analgesics in the Prevention of Chronic Migraine

Chronic Migraine Clinical Trial

Official title: A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallelist Study Evaluating the Efficacy, Safety, and Tolerability of Atogepant for the Prevention of Chronic Migraine (Progress)

Status Completed

Clinical Trial Summary

Study Objectives: To evaluate the safety and tolerability of atogepant 30 mg twice per day (BID) and 60 mg once daily for the prevention of chronic migraine (CM). To prospectively test for superiority of atogepant 30 mg BID and 60 mg once daily versus placebo for the prevention of CM.

Clinical Trial Description

Study Objectives: To evaluate the safety and tolerability of atogepant 30 mg twice per day (BID) and 60 mg once daily for the prevention of chronic migraine (CM). To prospectively test for superiority of atogepant 30 mg BID and 60 mg once daily versus placebo for the prevention of CM. Clinical Hypotheses: In participants with CM, at least one of the following atogepant doses (30 mg BID and 60 mg once daily) is superior to placebo as measured by the change from baseline in mean monthly migraine days across the 12-week treatment period. Atogepant has an acceptable safety and tolerability profile in participants with CM. Study Design Structure: Multicenter, randomized, double-blind, placebo-controlled, parallel-group study Duration: The study will consist of a 4-week screening and baseline period, a 12-week double-blind treatment period, and a follow-up period of 4 additional weeks, for a total duration of20 weeks Study Intervention: Atogepant 30 mg BID and 60 mg once daily tablets Control: Atogepant-matching placebo Dosage/Dose Regimen: Atogepant 30 mg BID, atogepant 60 mg once daily, and placebo will be administered for 12 weeks duration. Randomization/Stratification: Approximately 750 participants will be randomized to I of 3 treatment arms in a I: I: I ratio as follows: - Placebo (n = 250) - Atogepant 30 mg BID (n = 250) C • Atogepant 60 mg once daily (n = 250) ;

Related Conditions & MeSH terms

• Chronic Migraine
• Migraine Disorders

• NCT number: NCT04961671
• Study type: Interventional
• Source: Peking University Third Hospital
• Status: Completed
• Phase: Phase 3
• Start date: December 1, 2019
• Completion date: May 1, 2021