Clinical Trial: A Study of the Efficacy of RWJ-333369 in the Prevention of Migraine

This study is currently recruiting patients.

Sponsored by: Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
Information provided by: Johnson & Johnson Pharmaceutical Research and Development, L.L.C.

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 Treatment or Intervention Phase
Migraine Headaches
 Drug: RWJ-333369
Phase II

MedlinePlus related topics:  Migraine

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

Eligibility

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

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.

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00109083


Alabama
      Northport,  Alabama,  United States; Recruiting
Study Coordinator  205-333-2626 

Arizona
      Phoenix,  Arizona,  United States; Recruiting
Study Coordinator  602-636-1880 

Arkansas
      Little Rock,  Arkansas,  United States; Recruiting
Study Coordinator  501-227-4750 

California
      Berkeley,  California,  United States; Recruiting
Study Coordinator  510-849-0499  Ext. 36 

Colorado
      Golden,  Colorado,  United States; Recruiting
Study Coordinator  303-785-5992 

Florida
      St. Petersburg,  Florida,  United States; Recruiting
Study Coordinator  727-347-8839 

      Miami,  Florida,  United States; Recruiting
Study Coordinator  305-279-0015  Ext. 4221 

Illinois
      Chicago,  Illinois,  United States; Recruiting
Study Coordinator  773-388-6389 

Louisiana
      Baton Rouge,  Louisiana,  United States; Recruiting
Study Coordinator  225-757-1084 

Massachusetts
      Springfield,  Massachusetts,  United States; Recruiting
Study Coordinator  413-788-1400 

      Brockton,  Massachusetts,  United States; Recruiting
Study Coordinator  508-584-2030 

Minnesota
      Chaska,  Minnesota,  United States; Recruiting
Study Coordinator  952-556-2686 

Missouri
      Springfield,  Missouri,  United States; Recruiting
Study Coordinator  417-890-7888 

North Carolina
      Greensboro,  North Carolina,  United States; Recruiting
Study Coordinator  336-574-8020 

North Dakota
      Bismarck,  North Dakota,  United States; Recruiting
Study Coordinator  701-250-8410 

Ohio
      Mogadore,  Ohio,  United States; Recruiting
Study Coordinator  330-628-6001 

      Cincinnati,  Ohio,  United States; Recruiting
Study Coordinator  513-984-6887 

Tennessee
      Nashville,  Tennessee,  United States; Recruiting
Study Coordinator  615-284-4680 

Texas
      Richardson,  Texas,  United States; Recruiting
Study Coordinator  972-907-1333 

      Lake Jackson,  Texas,  United States; Recruiting
Study Coordinator  979-299-0405 

      Houston,  Texas,  United States; Recruiting
Study Coordinator  713-528-1916 

      Austin,  Texas,  United States; Recruiting
Study Coordinator  512-732-2444 

Virginia
      Alexandria,  Virginia,  United States; Recruiting
Study Coordinator  703-845-1500 

Washington
      Olympia,  Washington,  United States; Recruiting
Study Coordinator  360-786-0692 

Wisconsin
      Middleton,  Wisconsin,  United States; Recruiting
Study Coordinator  608-827-2300  Ext. 2353 

More Information

Study ID Numbers:  333369-MIG-2001
Record last reviewed:  April 2005
Last Updated:  April 22, 2005
Record first received:  April 22, 2005
ClinicalTrials.gov Identifier:  NCT00109083
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-05-03


Source: ClinicalTrials.gov
Cache Date: May 4, 2005

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