Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00236743
Status:
COMPLETED
Last Update Posted:
2011-06-08
First Post:
2005-10-07
Brief Title:
A Study of the Effectiveness and Safety of Topiramate in the Treatment of Children With Epilepsy
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
Topiramate RWJ 17021-000 Clinical Trial In Children With Partial Onset Seizures
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 safety and effectiveness of oral topiramate as add-on therapy in children with uncontrolled 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 8 weeks duration patients receive a stable dose of one or two standard antiepileptic drugs AEDs and the parent or guardian records the occurrences of seizure in a diary Patients who continue to have seizures during treatment with standard AEDs proceed into the double-blind treatment phase Patients then receive topiramate or placebo once daily at a dosage of 25 milligramsmg or 50 mg based on body weight to 6mgkg per day increasing gradually to twice daily dosing at a maximum of 125-400 mg based on body weight for 112 days 16 weeks 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 parents or guardians global assessment of medication at end of study Safety assessments include the incidence of adverse events throughout the study clinical laboratory tests hematology chemistry urinalysis neurologic examinations and vital sign measurements blood pressure pulse body weight at specific intervals 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 children with refractory partial epilepsy that is children who continue to have seizures despite treatment with first-line AEDs In addition it is hypothesized that topiramate is well-tolerated Oral topiramate daily for 112 days Starting dose is 25 mg or 50mg based on body weight Maximum doses based on patient weight 125 mgday 36-54 poundslb 175 mgday 55-74 lb 225 mgday 75-94 lb and 400 mgday 95 or more pounds Matching placebo was used to maintain blinding
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