Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00236717
Status:
COMPLETED
Last Update Posted:
2011-06-08
First Post:
2005-10-07
Brief Title:
A Study of the Effectiveness and Safety of Topiramate Compared With a Standard Therapy in Patients Newly Diagnosed With Epilepsy
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
TOPAMAX Topiramate Monotherapy Comparison Trial to Standard Monotherapy in the Treatment of Newly Diagnosed Epilepsy RWJ-17021-000 Phase IIIB
Status:
COMPLETED
Status Verified Date:
2011-01
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 effectiveness and safety of topiramate to standard antiepileptic drugs in children and adults with newly diagnosed epilepsy
Detailed Description:
Topiramate is a drug that is currently widely used for the treatment of seizures in adults and pediatric patients 2 to 16 years of age This is a randomized double-blind parallel-group study to evaluate the effectiveness and safety of two dosages of topiramate 100 or 200mg per day compared with standard antiepileptic drugs carbamazepine or valproate in patients with newly diagnosed epilepsy The study is composed of three phases baseline up to 7 days double-blind treatment and a blinded extension The double-blind phase is divided into two periods titration in which the dose of drug is gradually increased approximately 35 days and stabilization of variable duration with regular scheduled visits up to 92 days and then every 3 months thereafter The dose of study drug remains constant during the stabilization period In the blinded extension patients completing the double blind phase are given the opportunity to take the other study medication in a blinded fashion patient unaware of identity of the drug This phase continues until the patient leaves the study or the data base for the double blind phase is finalized The primary assessment of effectiveness is the time to first seizure from Day 15 of the study Safety assessments include the frequency of adverse events during the study results of clinical laboratory tests hematology and biochemistry measurements of vital signs and body weight and physical examination findings The study hypothesis is that the 200mg dose of topiramate is superior to the 100mg dose in delaying the time to first seizure and is well-tolerated Oral topiramate 25milligram mg or 50mg capsules or tabletsstarting at 25mgday Week 1increasing to 100mg or 200mgday Week 5Increasing carbamazepine to 600mgday or valproate to 1250mgday Week 5Maximum dosages continue for a variable time and then taper over 4 weeks to starting dose
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