A Study of the Efficacy of RWJ-333369 in the Prevention of Migraine

This study has been completed.

First Received: April 22, 2005 Last Updated: February 9, 2006 History of Changes

Sponsored by:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:	NCT00109083

Purpose

The purpose of this study is to evaluate whether RWJ-333369 is a safe and effective treatment in reducing the number of migraine headaches when added to a person's usual medications for acute migraine headache relief.

Condition	Intervention	Phase
Migraine Headaches	Drug: RWJ-333369	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging, Multicenter Study of the Efficacy of RWJ-333369 in the Prophylaxis of Migraine

Resource links provided by NLM:

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Headache Migraine

Drug Information available for: Carisbamate

U.S. FDA Resources

Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:

Percent reduction in the average monthly migraine frequency from the baseline period to the entire double-blind treatment phase.

Estimated Enrollment:	300
Study Start Date:	March 2005

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Established history of migraines for at least 1 year;
Have between 3 and 12 migraine attacks per month, and no more than 15 headache days in total per month;
Migraines must have first started before age 50.

Exclusion Criteria:

Most frequent headache type is not migraine;
Failed 3 or more studies of effective migraine-preventing medications;
Overuse of pain medications to treat migraines;
Not willing to stop use of migraine-preventing medications;
Significant serious concomitant diseases.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00109083

Show 25 Study Locations

Sponsors and Collaborators

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Investigators

Study Director:

Johnson & Johnson Pharmaceutical R & D, L.L.C., Clinical Trial

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

More Information

No publications provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Cady RK, Mathew N, Diener HC, Hu P, Haas M, Novak GP; Study Group. Evaluation of carisbamate for the treatment of migraine in a randomized, double-blind trial. Headache. 2009 Feb;49(2):216-26.

Study ID Numbers:	333369-MIG-2001
Study First Received:	April 22, 2005
Last Updated:	February 9, 2006
ClinicalTrials.gov Identifier:	NCT00109083 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Migraine
Headaches
Migraine headaches
Head pain

Study placed in the following topic categories:

Signs and Symptoms
Migraine Disorders
Headache
Central Nervous System Diseases
Neurologic Manifestations

Headache Disorders, Primary
Pain
Brain Diseases
Headache Disorders

Additional relevant MeSH terms:

Signs and Symptoms
Migraine Disorders
Nervous System Diseases
Headache
Central Nervous System Diseases

Neurologic Manifestations
Headache Disorders, Primary
Pain
Brain Diseases
Headache Disorders

ClinicalTrials.gov processed this record on September 03, 2009