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

Migraine Headaches Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00109083
• Other study ID #: 333369-MIG-2001
• Status: Completed
• Phase: Phase 2
• First received: April 22, 2005
• Last updated: August 1, 2012
• Start date: March 2002
• Est. completion date: February 2006

Study information

• Verified date: August 2012
• Source: SK Life Science
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: February 2006
• Est. primary completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Headache
• Migraine Disorders
• Migraine Headaches

Intervention

Drug:
• RWJ-333369

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
SK Life Science

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent reduction in the average monthly migraine frequency from the baseline period to the entire double-blind treatment phase.