A Study of the Efficacy and Safety of Topiramate in the Prevention of Migraine

Condition(s) targeted: Common Migraine; Headache; Migraine; Classic Migraine

Intervention: topiramate (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Official(s) and/or principal investigator(s):
Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial, Study Director, Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

The purpose of this study is to evaluate the safety and efficacy of three doses of topiramate (50 milligrams[mg], 100mg, and 200mg taken daily) compared with placebo in the prevention of migraine.

Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Response Study to Evaluate the Efficacy and Safety of Topiramate in the Prophylaxis of Migraine

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Changes in length of time between the onset and cessation of painful migraine symptoms (migraine period) from the baseline. Safety evaluations conducted throughout the study.

Secondary outcome: Proportion of patients responding to the treatment. Changes from baseline to double-blind phase in number of monthly migraine attacks, monthly migraine days, number of days/month requiring rescue medication, and Health-Related Quality of Life measures.

Detailed description: This is a randomized, double-blind, placebo-controlled, parallel-group, multi-center study to evaluate the effectiveness and safety of three different doses of topiramate (50mg, 100mg, and 200mg daily) in migraine prophylaxis. The study consists of five phases: baseline (determination of whether patients meet the eligibility criteria and tapering of any migraine medication patients are already taking); initial titration and double-blind phase (8 weeks) which begins with 25 mg/daily increasing to the assigned (50, 100, 200 mg/day topiramate); followed by a maintenance period at the target dose (18 weeks); tapering transition phase (up to 7 weeks); and open-label extension up to 6 months (to a maximum topirmate dose of 1600 mg/day); doses are adjusted to maximize effectiveness and minimize side effects. The primary study hypothesis is that one or more of the three doses of topiramate (50, 100, 200 mg/day) will be superior to placebo in the prophylaxis of migraine based on the change in monthly (28 day) migraine period rate from the prospective baseline period to the double-blind phase and that topiramate treatment is well tolerated.

During the titration period (8 weeks), doses are increased to target dose of daily topiramate (50 milligrams[mg], 100, or 200mg) or placebo, taken twice daily by mouth. Doses are continued for 18 weeks, adjusted over 7 weeks, and continued for up to 6 months during the Open-Label Extension.

Minimum age: 12 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Medical history consistent with migraine with or without aura according to the

International Headache Society (IHS) for at least 6 months prior to the study

- Between 3 to 12 migraine periods and no greater than 15 headache days (migraine and

non-migraine) per month during the Baseline Phase

- No clinically significant abnormalities on neurological exams, electrocardiogram (ECG)

or clinical laboratory test results at baseline

- Female patients must be postmenopausal for at least 1 year, surgically incapable of

childbearing, practicing abstinence, or practicing an acceptable method of contraception (requires negative pregnancy test)

Exclusion Criteria:

- Patients with headaches other than migraine

- Patients with episodic tension or sinus headaches

- Onset of migraine after age of 50 years

- Patients who have failed more than two adequate regimens for migraine prophylaxis

- Patients who overuse pain medications or certain other medications

Starting date: December 2000
Ending date: September 2002
Last updated: May 18, 2007