Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00210912
Status:
COMPLETED
Last Update Posted:
2011-06-10
First Post:
2005-09-13
Brief Title:
A Study of the Effectiveness and Safety of Topiramate Versus Placebo for Preventing Chronic Migraine Headaches
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
A Comparison of the Efficacy and Safety of Topiramate Versus Placebo for the Prophylaxis of Chronic Migraine
Status:
COMPLETED
Status Verified Date:
2010-04
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 assess the safety and effectiveness of topiramate as compared to placebo for the prevention of headaches in patients with chronic migraine Topiramate has been approved to prevent migraine headaches as well as in the treatment of epilepsy
Detailed Description:
Migraine headaches can be disabling and can interfere with work and a persons quality of life Preventing these headaches before they start is the best option Topiramate an anti-seizure medication has been shown to help prevent migraine headaches from occurring This is a multicenter randomized double-blind placebo-controlled parallel group study of patients with chronic migraine The Pretreatment Phase for the study will last up to 56 days and will consist of 2 study periods a ScreeningWashout Period Day -56 to Day -29 and a Prospective Baseline Period 28 days Medications being used to prevent migraines will be stopped for 14 to 28 days prior to the Prospective Baseline Period and for the rest of the study The Prospective Baseline Period will begin on study Day -28 Visit 2 and patients will maintain a daily headache record during this period Those who move forward in the study must have had at least 15 headache days during this period half of which need to be migraine headache days Patients who finish the Prospective Baseline Period who have the required rates of headache and who continue to meet the remainder of the entry criteria will be randomized like with the toss of a coin to 1 of 2 treatment groups topiramate 100 milligrams per day or placebo The Double-Blind Phase will last 16 weeks During the first 4 weeks patients will titrate up to the topiramate dose of 100 milligrams per day or to the maximum tolerated dose whichever is less The next 12 weeks is the maintenance phase where you will continue to take the dose that you were taking at the end of the 4-week titration period The primary hypothesis of this study is that the mean decrease in the number of migrainemigrainous headache days per month is greater in the topiramate group than in the placebo group and topiramate is generally well-tolerated
Topiramate 25 milligram tablets 2 tablets by mouth twice daily or maximum tolerated dose whichever is less for 12 weeks or 2 placebo tablets twice daily for 12 weeks
Topiramate 25 milligram tablets 2 tablets by mouth twice daily or maximum tolerated dose whichever is less for 12 weeks or 2 placebo tablets twice daily for 12 weeks
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