Comparative Study of Oral Atogepant Versus Oral Topiramate to Assess Adverse Events in Adult Participants With Migraine
Phase 3
Recruiting
- Conditions
- Migraine
- Registration Number
- NCT05748483
- Lead Sponsor
- AbbVie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 520
Inclusion Criteria
Inclusion Criteria:<br><br> - Documented history of migraine (with or without aura) for >= 12 months prior to<br> screening (Visit 1).<br><br> - History of >= 4 migraine days per month who require preventive treatment of migraine<br> and are eligible for conventional migraine prophylaxis.<br><br>Exclusion Criteria:<br><br> - Have used topiramate or atogepant in the past.<br><br> - Have clinically significant cardiovascular, cerebrovascular, hematologic, endocrine,<br> pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Participants Who Discontinued Treatment due to Adverse Events (AEs)
- Secondary Outcome Measures
Name Time Method Percentage of Participants Achieving >= 50% Improvement (Reduction) in Mean Monthly Migraine Days Based on mITT Population.