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...
Date First Received: September 28, 2004
Last Updated: July 5, 2006
Verified by: Merck, October 2005
Clinical Trial Phase: Phase 3 | Start Date: August 2004
Overall Status: Completed
Estimated Enrollment: 510
Brief Summary
Official Title: “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”
Condition Keyword(s):
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.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: MK0462, rizatriptan benzoate / Duration of Treatment: 1day
- Drug: Comparator: placebo / Duration of Treatment: 1 day
Outcome Measures for this Clinical Trial
Primary Measures
- Percentage of patients who are pain free at 2 hours postdose.
- Tolerabilty as measured by subjective adverse experience reporting.
Secondary Measures
- % of pts with 24 hr sustained pain freedom
- % of pts free @30/45/60/90 mins postdose
- % of pts with associated symptoms @2hr
- % of pts requiring rescue med btwn 2&24 hr
- % of pts with functional disabilty @2hr
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Merck
Related Publications
References
Cady R, Martin V, Mauskop A, Rodgers A, Hustad CM, Ramsey KE, Skobieranda F. Efficacy of Rizatriptan 10 mg administered early in a migraine attack. Headache. 2006 Jun;46(6):914-24.
Additional Information
Information obtained from ClinicalTrials.gov on October 10, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00092963
Study ID Number: 2004_022
ClinicalTrials.gov Identifier: NCT00092963
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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