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
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.
