Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00236561
Status:
COMPLETED
Last Update Posted:
2010-11-19
First Post:
2005-10-07
Brief Title:
A Study of the Efficacy and Safety of Two Doses of Topiramate Compared to Placebo and Propranolol in the Prevention of Migraine
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2010-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 milligramsmgday topiramate 200mgday topiramate 160mgday 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 TaperExit 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 mgday 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 milligramsmgday topiramate 200mgday topiramate 160mgday 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None