NCT04437433

A Study Evaluating Oral Atogepant for the Prevention of Migraine in Japanese Participants With Chronic or Episodic Migraine

A Phase 3, Multicenter, Open-Label 52-Week Extension Study to Evaluate the Long-Term Safety and Tolerability of Oral Atogepant for the Prevention of Migraine in Japanese Participants With Chronic or Episodic Migraine

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 186 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the long-term safety, efficacy and tolerability of atogepant 60 mg daily for the prevention of migraine in Japanese participants with chronic (CM) or episodic migraine (EM).

Detailed description

The study recruited the following 2 cohorts: 3101-303-002 CM Completers: Japanese participants who completed lead-in Study 3101 303-002 (PROGRESS; NCT03855137), a Phase 3, multicenter, randomized, double-blind, placebo controlled, parallel-group study of atogepant for the prevention of CM. All 3101 303-002 CM Completers rolled over at Visit 7 (the end of the double-blind treatment period) of the lead-in study, which functioned as Visit 1 for this study, Study 3101-306-002. De Novo EM Participants: Japanese participants with EM who were newly recruited for this study at selected sites. Participation began with a 4-week Screening/Baseline period starting at Visit -1, and those who completed the 4-week Screening/Baseline period and met all entry criteria were enrolled into the 52-week open-label treatment period at Visit 1.

Conditions

• Chronic Migraine
• Episodic Migraine

Interventions

Type	Name	Description
DRUG	Atogepant 60 mg	Tablets containing 60 mg atogepant

Timeline

• Start date: 2020-06-18
• Primary completion: 2024-06-11
• Completion: 2024-06-11
• First posted: 2020-06-18
• Last updated: 2025-07-22
• Results posted: 2025-07-22

Locations

24 sites across 1 country: Japan

Regulatory

• FDA-regulated drug study