Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00236730
Status:
COMPLETED
Last Update Posted:
2011-06-08
First Post:
2005-10-07
Brief Title:
A Study of the Efficacy and Safety of Topiramate in the Treatment of Patients With Difficult to Control Epilepsy
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 the study is to evaluate the effectiveness and safety of topiramate as add-on therapy in patients with difficult to control partial onset seizures who are taking one or two standard anti-epileptic 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 that includes a baseline phase and a treatment phase During the baseline phase 12 weeks duration patients receive one or two of the following standard antiepileptic drugs AEDs phenytoin carbamazepine phenobarbital or primidone 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 once daily increasing to twice daily dosing at a maximum dose of 200 mgday 400 mgday or 600 mgday or maximum tolerated dose depending on treatment group through Week 16 total duration of 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 and is well-tolerated Topiramate 100 milligramsmg oral tablets Dosage begins at 100-mg once daily and increases gradually to twice daily dosing at a maximum dose of 200 400 or 600 mgday and continues through Week 16 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