[M22-056] Study of Oral Atogepant Tablets to Assess Change in Disease Activity in Adult Japanese Participants With Episodic Migraine

JRCT ID: jRCT2031230217

Registered date:11/07/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Migraine
• Date of first enrollment: 12/07/2023
• Target sample size: 520
• Study type: Interventional

Intervention(s)

- Atogepant Dose A: Participants will receive atogepant dose A once daily (QD) for 24 weeks / Oral tablet
- Atogepant Dose B: Participants willreceive atogepant dose B QD for 24 weeks / Oral tablet
- Atogepant Dose C: Participants will receive atogepant dose C QD for 24 weeks / Oral tablet
- Placebo: Participants will receive placebo QD for 12 weeks. Participants will be re-randomized at week 12 to receive atogepant dose A,dose B or dose C QD for 12 weeks / Oral tablet

Outcome(s)

• Primary Outcome: Change From Baseline in Mean Monthly Migraine Days [Time Frame: Up to 12 Weeks]

Secondary Outcome

- Change From Baseline in Mean Monthly Headache Days
- Change From Baseline in Mean Monthly Acute Medication Use Days
- Percentage of Participants Achieving At Least 50% Reduction in the 3-month Average of Monthly Migraine Days
- Change From Baseline in Migraine Specific Quality of Life Questionnaire, Version2.1 (MSQ v2.1) Role Function-Restrictive Domain Score
- Change From Baseline in Mean Monthly Performance of Daily Activities DomainScore of the Activity Impairment in Migraine - Diary (AIM-D)
- Change From Baseline in Mean Monthly Physical Impairment Domain Score of the AIM-D

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

- At least a 1-year history of migraine (with or without aura).
- Less than 50 years of age at the time of migraine onset.
- History of 4 to 14 migraine days per month in the 3 months prior to screening.
- 4 to 14 migraine days in the baseline period and completed at least 20 out of 28 days at the baseline periodper the eDiary.

Exclude criteria

- Difficulty with distinguishing migraine headaches from tension-type or other headaches.
- Clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.

Related Information

• Primary Sponsor: Otani Tetsuya
• Secondary ID(s): NCT05861427