Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00236691
Status:
COMPLETED
Last Update Posted:
2011-06-08
First Post:
2005-10-07
Brief Title:
A Study of the Efficacy and Safety of Topiramate as add-on Therapy in the Treatment of Epilepsy Patients With Difficult to Treat Partial-onset Seizures
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
Double-Blind Parallel Comparison of Three Doses of Topiramate and Placebo in Refractory Partial Epilepsy
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 evaluate the efficacy and safety of topiramate as add-on therapy in patients with difficult to control partial onset seizures who are taking one or two standard antiepileptic drugs
Detailed Description:
Epilepsy is characterized by seizures which are abnormal electrical discharges in the brain that temporarily disrupt normal brain function Seizures are classified as generalized originating in both sides of the brain simultaneously or partial-onset starting in one area of the brain Antiepilepsy medications such as topiramate are selected based on seizure type This is a double-blind placebo-controlled study to evaluate the efficacy and safety of topiramate as add-on therapy in patients with refractory partial epilepsy that includes a baseline phase and a treatment phase in difficult to treat patients with partial epilepsy During the baseline phase 12 weeks duration patients receive one or two of the following standard antiepileptic drugs AEDs phenytoin carbamazepine phenobarbital primidone or valproic acid Patients who continue to have seizures during treatment with standard AEDs proceed into the double-blind treatment phase Patients then receive placebo or topiramate at a dosage of 100-milligrams mg twice daily increasing to twice daily dosing at a maximum dose 600 mgday 800 mgday or 1000 mgday or maximum tolerated dose depending on treatment group through Week 18 total duration of the double-blind phase while continuing on their standard AED regimen Assessments of effectiveness include the percent reduction in the average monthly seizure rate percent of patients responding to treatment having equal to or greater than 50 reduction in seizure rate and the patients and investigators global assessments of medication at end of study Safety assessments include the incidence of adverse events throughout the study clinical laboratory tests hematology serum chemistry urinalysis neurologic examinations and vital sign measurements blood pressure pulse temperature weekly during the treatment phase The study hypothesis is that topiramate taken as add-on therapy to treatment with AEDs will significantly reduce seizure frequency compared with placebo in patients with refractory partial epilepsy In addition it is hypothesized that topiramate is well-tolerated Topiramate 100 mg oral tablets or matching placebo Dosage begins at 100-mg twice daily and increases gradually to twice daily dosing at a maximum dose of 600 800 or 1000 mgday and continues through Week 18 total duration
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