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Sponsored by: |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
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Information provided by: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
ClinicalTrials.gov Identifier: | NCT00236561 |
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.
Condition | Intervention | Phase |
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Headache Classic Migraine Common Migraine Migraine |
Drug: topiramate, propranolol |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 568 |
Study Start Date: | December 2000 |
Estimated Study Completion Date: | December 2002 |
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 Phase.
Ages Eligible for Study: | 12 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Study ID Numbers: | CR003205 |
Study First Received: | October 7, 2005 |
Last Updated: | September 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00236561 |
Health Authority: | United States: Food and Drug Administration |
Topiramate Classic Migraine Migraine Prophylaxis |
Propranolol Common Migraine Headache Prevention |
Basilar artery migraines Central Nervous System Diseases Pain Headache Disorders, Primary Brain Diseases Headache Disorders Signs and Symptoms |
Propranolol Migraine Disorders Headache Neurologic Manifestations Topiramate Migraine with Aura Migraine without Aura |
Neurotransmitter Agents Vasodilator Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Nervous System Diseases Physiological Effects of Drugs Cardiovascular Agents Antihypertensive Agents Protective Agents |
Neuroprotective Agents Pharmacologic Actions Anti-Obesity Agents Therapeutic Uses Adrenergic beta-Antagonists Adrenergic Antagonists Anti-Arrhythmia Agents Central Nervous System Agents Anticonvulsants |