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

SK Life Science

Status and phase: Completed; Phase 2

Conditions: Migraine Headaches

Treatments: Drug: RWJ-333369

Study type: Interventional

Funder types: Industry

Identifiers

NCT00109083

333369-MIG-2001

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind