Study to Test an Approved Product in the Early Treatment of Migraine (0462-065)
Phase 3
Completed
- Conditions
- Migraine
- Registration Number
- NCT00092963
- Lead Sponsor
- Organon and Co
- Brief Summary
The purpose of this study is to test the effectiveness of an approved drug in the early treatment of migraine while the pain is still mild.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 529
Inclusion Criteria
- 6-month history of migraine
- Migraine attacks typically mild when they begin with 1-4 migraine attacks per month
Exclusion Criteria
- Heart disease
- High blood pressure
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Percentage of patients who are pain free at 2 hours postdose. Tolerability as measured by subjective adverse experience reporting.
- Secondary Outcome Measures
Name Time Method Percentage of patients requiring rescue med between 2 & 24 hours Percentage of patients with 24 hour sustained pain freedom Percentage of patients free at 30/45/60/90 minutes postdose Percentage of patients with associated symptoms at 2 hours Percentage of patients with functional disability at 2 hours