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Clinical Trials/NCT00095004
NCT00095004CompletedPhase 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 enrollmentStarted: October 21, 2004Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
167
Primary Endpoint
Percentage of patients who are pain free at 2 hours postdose
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose of this study is to test the effectiveness of an approved drug in the early treatment of migraine.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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