Clinical trial NCT00109083: A Study of the Efficacy of RWJ-333369 in the Prevention of Migraine
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Migraine Headaches
Keywords: Migraine
Headaches
Migraine headaches
Head pain
Lead sponsor: SK Life Science, Inc.
Sponsor class: INDUSTRY
First posted: 2005-04-25
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Percent reduction in the average monthly migraine frequency from the baseline period to the entire double-blind treatment phase.
Secondary outcomes:
Other outcomes:
Locations:
city: Northport
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Berkeley
country: United States
state: California
city: Golden
country: United States
state: Colorado
city: Miami
country: United States
state: Florida
city: St. Petersburg
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Baton Rouge
country: United States
state: Louisiana
city: Brockton
country: United States
state: Massachusetts
city: Springfield
country: United States
state: Massachusetts
city: Chaska
country: United States
state: Minnesota
city: Springfield
country: United States
state: Missouri
city: Greensboro
country: United States
state: North Carolina
city: Bismarck
country: United States
state: North Dakota
city: Cincinnati
country: United States
state: Ohio
city: Mogadore
country: United States
state: Ohio
city: Nashville
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Lake Jackson
country: United States
state: Texas
city: Richardson
country: United States
state: Texas
city: Alexandria
country: United States
state: Virginia
city: Olympia
country: United States
state: Washington
city: Middleton
country: United States
state: Wisconsin
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Johnson & Johnson Pharmaceutical R & D, L.L.C., Clinical Trial
role: STUDY_DIRECTOR
References:
citation: 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.