Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00216606
Status:
COMPLETED
Last Update Posted:
2011-02-01
First Post:
2005-09-13
Brief Title:
The Effectiveness and Safety of Topiramate on Prevention of Chronic Migraine
Sponsor:
Janssen Pharmaceutica NV Belgium
Organization:
Janssen Pharmaceutica NV Belgium
Study Overview
Official Title:
A Randomized Double-Blind Placebo Controlled Trial to Investigate the Efficacy and Tolerability of Topiramate in the Prophylaxis of Chronic Migraine
Status:
COMPLETED
Status Verified Date:
2011-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
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 effectiveness of individualized doses 50 to 200 milligrams of topiramate tablets compared against placebo for the prevention of chronic migraine headaches over a period of 16 weeks
Detailed Description:
Previous studies have shown that topiramate is effective in preventing chronic migraine headaches This study will start with a 4-week baseline period in which no treatment is given followed by a 12-week period in which each patients dose is adjusted and then kept stable for the last 4 weeks of the 16-week double-blind phase The individualized dose will start at 25 milligrams of topiramate per day and will be increased 25 milligrams per day once weekly and then raised to either the target--100 milligrams per day--or the maximum dose that is well tolerated up to 200 milligrams per day Patients who are randomized to receive topiramate will remain on the optimized dose The comparison phase of the study is a 16-week period in which the change in migraine days of patients on topiramate taking at least 50 milligrams per day is compared with the change in migraine days for patients on the placebo Also studied will be the patients health-related quality of life as assessed by questionnaires filled out at specific visits as well as the patients views of the safety and tolerability of topiramate The study hypothesis is that the number of migraine days periods and attacks from the baseline period to the last 4 weeks in the double-blind period is reduced more in the topiramate group than the placebo group During the 16-week comparison period patients will take by mouth a dose of 50 milligrams to 200 milligrams of topiramate daily
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