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Study to Test an Approved Product in the Early Treatment of Migraine (0462-066)

Phase 3
Completed
Conditions
Migraine
Registration Number
NCT00095004
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
167
Inclusion Criteria
  • Six month history of migraine; attacks typically mild when they begin with 1-4 migraine attacks per month.
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Exclusion Criteria
  • Heart disease
  • High blood pressure
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Percentage of patients who are pain free at 2 hours postdose
Tolerability as measured by subjective adverse experience reporting
Secondary Outcome Measures
NameTimeMethod
Percentage of patients with 24 hour sustained pain freedom
Percentage of patients requiring rescue medication between 2 & 24 hours
Percentage of patients pain free at 30/45/60/90 minutes post dose
Percentage of patients with associated symptoms at 2 hours
Percentage of patients with functional disability at 2 hours
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