Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00216619
Status:
COMPLETED
Last Update Posted:
2014-07-02
First Post:
2005-09-13
Brief Title:
The Prolonged Use of Topiramate for Preventing Migraine Headaches
Sponsor:
Janssen Pharmaceutica NV Belgium
Organization:
Janssen Pharmaceutica NV Belgium
Study Overview
Official Title:
A Double-Blind Randomized Placebo-Controlled Multicenter Trial to Investigate the Efficacy and Tolerability of Topiramate in Prolonged Migraine Prevention
Status:
COMPLETED
Status Verified Date:
2014-07
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:
PROMPT
Brief Summary:
The purpose of this study is to evaluate the safety and effectiveness beyond 6 months of individualized doses 100 to 200 milligrams of topiramate for the prevention of migraine headaches over a period of 26 weeks
Detailed Description:
Previous studies have shown that topiramate is effective in preventing migraine headaches This study will start with a 4-week baseline period in which no treatment is given followed by a 26-week period in which each patients dose is adjusted and then kept stable for 4 weeks The 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 randomized to receive topiramate will remain on that dose The comparison phase of the study is a 26-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 during the last 4 weeks of the double-blind phase relative to the last 4 weeks of the open-label phase is reduced more in the topiramate group than the placebo group During open-label 26-weeks and double-blind phase 26-weeks patients receiving topiramate will take 25 milligrams to 100 milligrams daily by mouth increased by 25 milligrams per day once weekly dose cannot exceed 200 milligrams per day and must be stable for the last 4 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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| TOPMAT-MIG-303 | OTHER | Janssen CTMS ID | None |
| 2005-000321-29 | EUDRACT_NUMBER | None | None |