The purpose of this study is to investigate the efficacy and safety of MK0974 compared to an approved medication for acute migraine...
Date First Received: February 28, 2007
Last Updated: October 23, 2007
Verified by: Merck, October 2007
Clinical Trial Phase: Phase 3 | Start Date: March 2007
Overall Status: Completed
Estimated Enrollment: 1800
Brief Summary
Official Title: “A Multicenter, Double-Blind, Placebo-Controlled, Parallel Group Study to Compare the Response to a Single Treatment With Oral MK0974 With Placebo and Comparator in Subjects With Moderate to Severe Acute Migraine With or Without Aura”
Condition Keyword(s):
The purpose of this study is to investigate the efficacy and safety of MK0974 compared to an approved medication for acute migraine.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Outcome Measures for this Clinical Trial
Primary:
- Pain Freedom at 2 hours post-dose, Pain Relief at 2 hours post-dose, Absence of photophobia, phonophobia, and nausea at 2 hrs post-dose
Secondary:
- Sustained Pain-Freedom from 2 to 24 hours after study drug administration, Total Migraine Freedom at 2 hours post-dose, Total Migraine Freedom from 2 to 24 hours post-dose
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Patient has at least 1 year history of migraine (with or without aura)
- Females of child bearing potential must use acceptable contraception throughout trial
Exclusion Criteria:
- Patient is pregnant/breast-feeding (or is a female expecting to conceive during study period)
- Patient has history or evidence of stroke/transient ischemic attacks, heart disease, coronary artery vasospasm, other significant underlying cardiovascular diseases, uncontrolled hypertension (high blood pressure), uncontrolled diabetes, or HIV disease
- Patient has major depression, other pain syndromes that might interfere with study assessments, psychiatric conditions, dementia, or significant neurological disorders (other than migraine)
- Patient has a history of gastric, or small intestinal surgery, or has a disease that causes malabsorption
- Patient has a history of cancer within the last 5 years
Clinical Trials Locations, Contact Details, and Sponsors
Lead Sponsor: Merck
Overall Clinical Trial Officials and Contacts
Medical Monitor Study Director Merck
Additional Information
Information obtained from ClinicalTrials.gov on July 18, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00442936
Study ID Number: 2006_525
ClinicalTrials.gov Identifier: NCT00442936
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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