Title
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
Phase
Phase 2Lead Sponsor
ArvelleStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Migraine HeadachesIntervention/Treatment
carisbamate ...Study Participants
300The 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.
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.