MK0974 Pivotal Study 1 - WW (With Active Comparator) - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00442936

Purpose

The purpose of this study is to investigate the efficacy and safety of MK0974 compared to an approved medication for acute migraine.

Condition	Intervention	Phase
Migraine	Drug: MK0974 / Duration of Treatment: 1 Day Drug: Comparator: zolmitriptan / Duration of Treatment: 1 Day Drug: Comparator: placebo (unspecified) / Duration of Treatment: 1 Day	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
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

Resource links provided by NLM:

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Migraine

Drug Information available for: Zolmitriptan

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome 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 Outcome 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

Estimated Enrollment:	1800
Study Start Date:	March 2007
Study Completion Date:	October 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00442936

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Publications:

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.

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2006_525, MK0974-011
Study First Received:	February 28, 2007
Last Updated:	January 30, 2009
ClinicalTrials.gov Identifier:	NCT00442936 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Serotonin Agonists
Neurotransmitter Agents
Zolmitriptan
Migraine Disorders
Headache

Central Nervous System Diseases
Headache Disorders, Primary
Brain Diseases
Serotonin
Headache Disorders

Additional relevant MeSH terms:

Serotonin Agonists
Neurotransmitter Agents
Zolmitriptan
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs
Central Nervous System Diseases

Headache Disorders, Primary
Brain Diseases
Pharmacologic Actions
Headache Disorders
Serotonin Agents
Migraine Disorders

ClinicalTrials.gov processed this record on July 02, 2009