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

NCT ID: NCT00109083

Last Updated: 2012-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-03-31

Study Completion Date

2006-02-28

Brief Summary

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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

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Conditions

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Migraine Headaches

Keywords

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Migraine Headaches Migraine headaches Head pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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RWJ-333369

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SK Life Science, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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

Role: STUDY_DIRECTOR

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

Locations

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Northport, Alabama, United States

Site Status

Phoenix, Arizona, United States

Site Status

Little Rock, Arkansas, United States

Site Status

Berkeley, California, United States

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Golden, Colorado, United States

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Miami, Florida, United States

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St. Petersburg, Florida, United States

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Chicago, Illinois, United States

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Baton Rouge, Louisiana, United States

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Brockton, Massachusetts, United States

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Springfield, Massachusetts, United States

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Chaska, Minnesota, United States

Site Status

Springfield, Missouri, United States

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Greensboro, North Carolina, United States

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Bismarck, North Dakota, United States

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Cincinnati, Ohio, United States

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Mogadore, Ohio, United States

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Nashville, Tennessee, United States

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Austin, Texas, United States

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Houston, Texas, United States

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Lake Jackson, Texas, United States

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Richardson, Texas, United States

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Alexandria, Virginia, United States

Site Status

Olympia, Washington, United States

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Middleton, Wisconsin, United States

Site Status

Countries

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United States

References

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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. doi: 10.1111/j.1526-4610.2008.01326.x.

Reference Type DERIVED
PMID: 19222595 (View on PubMed)

Other Identifiers

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333369-MIG-2001

Identifier Type: -

Identifier Source: org_study_id