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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00109083

Enrollment

300

Registered

2005-04-25

Start date

2002-03-31

Completion date

2006-02-28

Last updated

2012-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine Headaches

Keywords

Migraine, Headaches, Migraine headaches, Head pain

Brief 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.

Interventions

DRUGRWJ-333369

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026