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: May 22, 2009
Verified by: Merck, May 2009
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 (Subject, Investigator), 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
Overall Clinical Trial Officials and Contacts
Medical Monitor Study Director 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.
Martin V, Cady R, Mauskop A, Seidman LS, Rodgers A, Hustad CM, Ramsey KE, Skobieranda F. Efficacy of rizatriptan for menstrual migraine in an early intervention model: a prospective subgroup analysis of the rizatriptan TAME (Treat A Migraine Early) studies. Headache. 2008 Feb;48(2):226-35. Epub 2007 Nov 13.
Cady R, Martin V, Mauskop A, Rodgers A, Hustad CM, Ramsey KE, Skobieranda F. Symptoms of cutaneous sensitivity pre-treatment and post-treatment: results from the rizatriptan TAME studies. Cephalalgia. 2007 Sep;27(9):1055-60. Epub 2007 Aug 6.
Ho TW, Rodgers A, Bigal ME. Impact of recent prior opioid use on rizatriptan efficacy. A post hoc pooled analysis. Headache. 2009 Mar;49(3):395-403. Epub 2008 Feb 12.
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
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
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
