[M22-056] Study of Oral Atogepant Tablets to Assess Change in Disease Activity in Adult Japanese Participants With Episodic Migraine
Phase 2
Recruiting
- Conditions
- Migraine
- Registration Number
- JPRN-jRCT2031230217
- Lead Sponsor
- Otani Tetsuya
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 520
Inclusion 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.
Exclusion Criteria
- Difficulty with distinguishing migraine headaches from tension-type or other headaches.
- Clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change From Baseline in Mean Monthly Migraine Days [Time Frame: Up to 12 Weeks]
- Secondary Outcome Measures
Name Time Method - Change From Baseline in Mean Monthly Headache Days<br>- Change From Baseline in Mean Monthly Acute Medication Use Days<br>- Percentage of Participants Achieving At Least 50% Reduction in the 3-month Average of Monthly Migraine Days<br>- Change From Baseline in Migraine Specific Quality of Life Questionnaire, Version2.1 (MSQ v2.1) Role Function-Restrictive Domain Score<br>- Change From Baseline in Mean Monthly Performance of Daily Activities DomainScore of the Activity Impairment in Migraine - Diary (AIM-D)<br>- Change From Baseline in Mean Monthly Physical Impairment Domain Score of the AIM-D