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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

SK Life Science

ClinicalTrials.gov Identifier:

NCT00109083

First received: April 22, 2005

Last updated: August 1, 2012

Last verified: August 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

April 22, 2005

Last Updated Date

August 1, 2012

Start Date ^ICMJE

March 2002

Primary Completion Date

February 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00109083 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging, Multicenter Study of the Efficacy of RWJ-333369 in the Prophylaxis of Migraine

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Migraine Headaches

Intervention ^ICMJE

Drug: RWJ-333369

Study Arm (s)

Not Provided

Publications *

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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

300

Completion Date

February 2006

Primary Completion Date

February 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00109083

Other Study ID Numbers ^ICMJE

333369-MIG-2001

Has Data Monitoring Committee

Not Provided

Responsible Party

SK Life Science

Study Sponsor ^ICMJE

SK Life Science

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

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

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

Information Provided By

SK Life Science

Verification Date

August 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top