Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00231556
Status:
COMPLETED
Last Update Posted:
2011-06-08
First Post:
2005-09-30
Brief Title:
A Study on Safety and Efficacy of Two Doses of Topiramate as Monotherapy in the Treatment of Newly Diagnosed or Recurrent Epilepsy
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
A Randomized Double-Blind Parallel-Group Monotherapy Study to Compare the Safety and Efficacy of Two Doses of Topiramate in the Treatment of Newly Diagnosed or Recurrent Epilepsy
Status:
COMPLETED
Status Verified Date:
2010-01
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 compare the safety and effectiveness of two doses of topiramate as monotherapy in the treatment of pediatric and adult patients with newly diagnosed or recurrent epilepsy
Detailed Description:
Topiramate is approved for treating epilepsy in combination with other epilepsy drugs but not approved for treating epilepsy as sole treatment or in recently diagnosed epilepsy characterized by partial-onset seizures This is a randomized double-blind parallel-group multicenter study to compare the safety and effectiveness of two doses of topiramate as monotherapy in pediatric and adult patients with newly diagnosed within 3 months or recurrent epilepsy partial-onset or primary generalized tonic-clonic The study consists of 4 phases Baseline assessment of seizure frequency and other eligibility Open-Treatment all patients receive 25 milligramsmgday of topiramate for 7 days Core Double-Blind Phase patients are randomized to receive either their assigned dose of topiramate of 50mgday or 400mgday or maximum tolerated dose and then remain if possible on that dose for the duration of the double-blind phase they continue to receive the medication until they experience the first seizure or until 6 months after the last patient is enrolled and Long-Term Extension Phase patients continue to receive the medication at maximum tolerated dose which may be adjusted according to individual tolerability and effectiveness until either the patient withdraws or the sponsor terminates the study The study hypothesis is that topiramate will be effective in the treatment of newly diagnosed or recurrent epilepsy in dose-dependent manner Topiramate tablets 25 milligramsmg daily by mouth in once-daily regimen during the 7-day Open-Treatment Phase topiramate twice daily for total of 50mgday or 400mgday during the Double-Blind 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