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Clinical Trials/NCT00095004
NCT00095004
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 sites167 target enrollmentOctober 21, 2004
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ConditionsMigraine
DrugsMK0462, rizatriptan benzoate / Duration of Treatment: 1dayComparator: placebo / Duration of Treatment: 1 day

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Migraine
Sponsor
Organon and Co
Enrollment
167
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.

Registry
clinicaltrials.gov
Start Date
October 21, 2004
End Date
April 4, 2005
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Six month history of 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 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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