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: January 30, 2009
Verified by: Merck, January 2009
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 (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: MK0974 / Duration of Treatment: 1 Day
- Drug: Comparator: zolmitriptan / Duration of Treatment: 1 Day
- Drug: Comparator: placebo (unspecified) / Duration of Treatment: 1 Day
Outcome Measures for this Clinical Trial
Primary Measures
- 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 Measures
- 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
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
Ho TW, Ferrari MD, Dodick DW, Galet V, Kost J, Fan X, Leibensperger H, Froman S, Assaid C, Lines C, Koppen H, Winner PK. Efficacy and tolerability of MK-0974 (telcagepant), a new oral antagonist of calcitonin gene-related peptide receptor, compared with zolmitriptan for acute migraine: a randomised, placebo-controlled, parallel-treatment trial. Lancet. 2008 Dec 20;372(9656):2115-23. Epub 2008 Nov 25.
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
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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