Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00236847
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 Epilepsy
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
Double-Blind Parallel Comparison of Topiramate 300 mg Twice Daily to Placebo in Patients With Refractory Partial Epilepsy
Status:
COMPLETED
Status Verified Date:
2010-04
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 effectiveness and safety of topiramate as an add-on therapy in patients with uncontrolled 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 study is designed to study patients with partial epilepsy This is a double-blind placebo-controlled study that includes a baseline phase and a treatment phase During the baseline phase 8 weeks duration patients receive one or two standard antiepileptic drugs AEDs such as 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 topiramate or placebo at a dosage of 100-milligrams mg once daily increasing gradually to 3 tablets twice daily 600 mgday maximum for 12 weeks 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 that is in patients who continue to have seizures despite treatment with a first-line AEDs In addition it is hypothesized that topiramate is well-tolerated Topiramate 100 milligrams mg oral tablets Dosage begins at 100 mg once daily and increases gradually over 4 weeks to 3 tablets twice daily 600 mgday maximum or maximum tolerated dose for an additional 8 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