Study to Test an Approved Product in the Early Treatment of Migraine
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...
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”
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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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.
- Tolerability as measured by subjective adverse experience reporting.
Secondary Measures
- 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 requiring rescue med between 2 & 24 hours
- Percentage of patients with functional disability at 2 hours
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 Investigator Information
Lead Investigator: Merck Industry
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 February 12, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00092963
