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

August 1, 2012 updated by: SK Life Science, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

300

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Northport, Alabama, United States
    • Arizona
      • Phoenix, Arizona, United States
    • Arkansas
      • Little Rock, Arkansas, United States
    • California
      • Berkeley, California, United States
    • Colorado
      • Golden, Colorado, United States
    • Florida
      • Miami, Florida, United States
      • St. Petersburg, Florida, United States
    • Illinois
      • Chicago, Illinois, United States
    • Louisiana
      • Baton Rouge, Louisiana, United States
    • Massachusetts
      • Brockton, Massachusetts, United States
      • Springfield, Massachusetts, United States
    • Minnesota
      • Chaska, Minnesota, United States
    • Missouri
      • Springfield, Missouri, United States
    • North Carolina
      • Greensboro, North Carolina, United States
    • North Dakota
      • Bismarck, North Dakota, United States
    • Ohio
      • Cincinnati, Ohio, United States
      • Mogadore, Ohio, United States
    • Tennessee
      • Nashville, Tennessee, United States
    • Texas
      • Austin, Texas, United States
      • Houston, Texas, United States
      • Lake Jackson, Texas, United States
      • Richardson, Texas, United States
    • Virginia
      • Alexandria, Virginia, United States
    • Washington
      • Olympia, Washington, United States
    • Wisconsin
      • Middleton, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SK Life Science, Inc.

Investigators

  • Study Director: Johnson & Johnson Pharmaceutical R & D, L.L.C., Clinical Trial, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2002

Primary Completion (ACTUAL)

February 1, 2006

Study Completion (ACTUAL)

February 1, 2006

Study Registration Dates

First Submitted

April 22, 2005

First Submitted That Met QC Criteria

April 22, 2005

First Posted (ESTIMATE)

April 25, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

August 2, 2012

Last Update Submitted That Met QC Criteria

August 1, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 333369-MIG-2001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Migraine Headaches

Clinical Trials on RWJ-333369

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Switzerland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe