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Clinical Trials/NCT00092963
NCT00092963
Completed
Phase 3

A Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled Study to Examine the Efficacy of Rizatriptan 10 mg Tablet Administered Early During a Migraine Attack While the Pain is Mild

Organon and Co0 sites529 target enrollmentAugust 17, 2004
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ConditionsMigraine

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Migraine
Sponsor
Organon and Co
Enrollment
529
Primary Endpoint
Percentage of patients who are pain free at 2 hours postdose.
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 17, 2004
End Date
January 14, 2005
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Percentage of patients who are pain free at 2 hours postdose.

Tolerability as measured by subjective adverse experience reporting.

Secondary Outcomes

  • 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

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