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

Completed

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Key information

Conditions

Migraine Headaches Brain Diseases Central Nervous System Diseases Headache Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Northport, Alabama, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

RWJ-333369

Drug

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

SK Life Science, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start: 2002
Primary completion: 2006
Study completion: 2006
First posted: Apr 25, 2005
Registry last updated: Aug 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed