NCT00111709CompletedPhase 3
A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo Controlled Study to Evaluate the Efficacy and Tolerability of Rizatriptan 10 mg Tablets for the Treatment of Menstrual Migraine
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Organon and Co
- Enrollment
- 393
- Primary Endpoint
- Percentage of patients with 2 hour pain relief: 4-point headache severity scale as recorded in patient diary
Study Overview
Brief Summary
The purpose of this study is to test the effectiveness of a marketed drug in the treatment of a menstrual migraine attack.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Female patient at least 18 years old
- •Patient has menses approximately monthly
- •Patient has at least a 5 month history of migraine and at least a 6 month history of menstrual migraine
Exclusion Criteria
- •Pregnant and/or nursing
- •Cardiovascular disease
- •Uncontrolled hypertension
Outcomes
Primary Outcomes
Percentage of patients with 2 hour pain relief: 4-point headache severity scale as recorded in patient diary
Secondary Outcomes
- Percentage of patients with 24-hr sustained pain relief: headache severity between 2 and 24 hrs post dose as recorded in patient diary
Investigators
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