Study to Test a Marketed Drug in the Treatment of Menstrual Migraine (0462-072)
Phase 3
Completed
- Conditions
- Migraine
- Registration Number
- NCT00111722
- Lead Sponsor
- Organon and Co
- Brief Summary
The purpose of this study is to test the effectiveness of a marketed drug in the treatment of a menstrual migraine attack.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 393
Inclusion Criteria
- Female patient at least 18 years old
- Patient has menses approximately monthly
- Patient has at least a 6 month history of migraine and at least a 6 month history of menstrual migraine
Exclusion Criteria
- Pregnant and/or nursing mother
- Cardiovascular disease
- Uncontrolled hypertension
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Percentage of patients with 2 hour pain relief: 4-point headache severity scale as recorded in patient diary
- Secondary Outcome Measures
Name Time Method Percentage of patients with 24-hr sustained pain relief: headache severity between 2 and 24 hrs post dose recorded in patient diary