A Dose-Finding Study of MK0974 in Acute Migraine

This study has been completed.

First Received: October 27, 2005 Last Updated: January 30, 2009 History of Changes

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00246337

Purpose

The purpose of this study is to investigate the efficacy and safety of an MK 0974 for migraine headache and to identify an appropriate dose range for further study.

Condition	Intervention	Phase
Migraine	Drug: MK0974	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Multicenter, Double-Blind, Placebo and Active-Controlled, Dose-Finding Study of MK0974 in the Treatment of Acute Migraine

Resource links provided by NLM:

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Headache Migraine

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Pain relief at 2 hours. [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pain freedom at 2 and 24 hours; pain relief at 24 hours. [ Time Frame: At 2 and 24 hours ] [ Designated as safety issue: No ]

Enrollment:	390
Study Start Date:	November 2005
Study Completion Date:	May 2006

Eligibility

Ages Eligible for Study:	20 Years to 65 Years
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 childbearing years must use acceptable contraception throughout trial
Patient is in general good health based on screening assessment

Exclusion Criteria:

Patient is pregnant/breast-feeding (or is a female expecting to conceive during the study period)
Patient has heart disease, uncontrolled hyper tension (high blood pressure), uncontrolled diabetes or other significant disease
Patient has major depression, other pain syndromes that might interfere with study assessments, psychiatric conditions, dementia, or significant neurological disorders (other then 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: NCT00246337

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Publications:

Ho TW, Mannix LK, Fan X, Assaid C, Furtek C, Jones CJ, Lines CR, Rapoport AM; MK-0974 Protocol 004 study group. Randomized controlled trial of an oral CGRP receptor antagonist, MK-0974, in acute treatment of migraine. Neurology. 2008 Apr 15;70(16):1304-12. Epub 2007 Oct 3.

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2005_082, MK0974-004
Study First Received:	October 27, 2005
Last Updated:	January 30, 2009
ClinicalTrials.gov Identifier:	NCT00246337 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Signs and Symptoms
Migraine Disorders
Headache
Central Nervous System Diseases

Headache Disorders, Primary
Brain Diseases
Headache Disorders

Additional relevant MeSH terms:

Migraine Disorders
Nervous System Diseases
Central Nervous System Diseases

Headache Disorders, Primary
Brain Diseases
Headache Disorders

ClinicalTrials.gov processed this record on September 10, 2009