Study to Test an Approved Product in the Early Treatment of Migraine (0462-065)(COMPLETED)
This study has been completed.
Information provided by:
First received: September 28, 2004
Last updated: May 20, 2013
Last verified: May 2013
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.
Drug: MK0462, rizatriptan benzoate / Duration of Treatment: 1day
Drug: Comparator: placebo / Duration of Treatment: 1 day
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|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|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Merck:
Primary Outcome Measures:
- Percentage of patients who are pain free at 2 hours postdose.
- Tolerability as measured by subjective adverse experience reporting.
Secondary Outcome 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
|Study Start Date:||August 2004|
|Primary Completion Date:||January 2005 (Final data collection date for primary outcome measure)|
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