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

Study Timeline

• Study Start: 2004-08-17
• Study First Submitted: 2004-09-28
• Study First Submitted QC: 2004-09-28
• Study First Posted: 2004-09-29
• Primary Completion: 2005-01-14
• Study Completion: 2005-01-14
• Status Verified: 2022-02
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-14

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