Study to Test a Marketed Drug in the Treatment of Menstrual Migraine (0462-071)

Phase 3

Completed

• Conditions: Migraine

• Registration Number: NCT00111709
• 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

Study Timeline

• Study First Submitted: 2005-05-24
• Study First Submitted QC: 2005-05-24
• Study First Posted: 2005-05-25
• Study Start: 2005-05-27
• Primary Completion: 2006-02-24
• Study Completion: 2006-02-26
• Status Verified: 2022-02
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-14

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 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

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 as recorded in patient diary