A Study of the Efficacy and Safety of Two Doses of Topiramate Compared to Placebo and Propranolol in the Prevention of Migraine
Information source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Headache; Classic Migraine; Common Migraine; Migraine
Intervention: topiramate, propranolol (Drug)
Phase: Phase 3
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 two doses of topiramate
(100 and 200 mg daily) versus placebo and propranolol in the prevention of migraine. The
study will also assess dose response relationship of topiramate, estimate the relative
efficacy of topiramate versus propranolol in prevention of migraine, and evaluate the effect
of migraine prevention with topiramate versus placebo on Health Related Quality of Life.
Official title: A Randomized, Double-Blind, Parallel-Group, Dose-Response Study to Evaluate the Efficacy and Safety of Two Doses of Topiramate Compared to Placebo and Propranolol in the Prophylaxis of Migraine
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Change in the monthly (28 days) migraine period rate from the Prospective Baseline Period to the Core Double-Blind Phase.
This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter study to
evaluate the efficacy and safety of two doses of topiramate versus placebo and propranolol in
the prevention of migraine headaches. The study consists of 4 phases: Baseline Phase
(evaluation of eligibility criteria and tapering of any migraine prophylaxis medications
patients are taking), Core Double-Blind Phase (patients are randomized to receive either 100
milligrams[mg]/day topiramate, 200mg/day topiramate, 160mg/day propranolol or placebo for a
total of 26 weeks), Blinded Extension Phase (patients continue the same dose of medication
until the sponsor terminates the study or a patient withdraws from the study), and Taper/Exit
Phase (medication of patients exiting from the study is tapered over 7 weeks). The primary
hypothesis is that one or two topiramate doses (100, 200 mg/day) will be superior to placebo
in the prophylaxis of migraine based on the change in the monthly (28 days) migraine period
rate from the prospective Baseline Phase to the Core Double-Blind Phase.
Oral medication (100 milligrams[mg]/day topiramate, 200mg/day topiramate, 160mg/day
propranolol, or placebo) during the 26-weeks Core Double-Blind Phase. Doses may be continued
until the termination of the study or withdrawal by the patients during the Blinded Extension
Minimum age: 12 Years.
Maximum age: 65 Years.
- Medical history consistent with migraine with or without aura according to the
International Headache Society (IHS) for at least 1 year 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)
- 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
Locations and Contacts
Starting date: December 2000
Ending date: December 2002
Last updated: May 11, 2007