Ignite Creation Date:
2024-05-05 @ 12:11 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00266604
Status:
COMPLETED
Last Update Posted:
2011-06-10
First Post:
2005-12-16
Brief Title:
A Study to Evaluate the Dosing Effectiveness and Safety of Topiramate for the Treatment of Epilepsy
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
TOPAMAX Topiramate Initiated as Monotherapy in Epilepsy TIME A Multicenter Outpatient Open-Label Study to Evaluate the Dosing Effectiveness and Safety of TOPAMAX as Monotherapy in the Treatment of Epilepsy in Clinical Practice
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 identify patient characteristics such as baseline seizure frequency that may predict effective doses of topiramate using just that one drug monotherapy as initial therapy for epilepsy Topiramate is an anti-epileptic drug that is approved for the treatment of epilepsy in adults and children 2 years of age and above
Detailed Description:
Any number of factors could affect the dosage needs for an anti-epileptic medication however various lines of evidence suggest that characteristics of the patients epilepsy itself could be important determinants Baseline ie at the start of the study patient characteristics particularly seizure frequency may predict dosage needs when TOPAMAX topiramate is initiated as monotherapy and titrated to an individualized optimal dose Topiramate is an anti-epileptic drug that is approved for epilepsy either alone ie monotherapy or in combination with other anti-epileptic medications in adults and children 2 years of age and above This is a multicenter outpatient open-label single-arm study to evaluate the dosing tolerability effectiveness and safety of topiramate as initial therapy for epilepsy in clinical practice Patients who have been identified by their physicians as candidates for initial anti-epileptic monotherapy will be enrolled Patients will begin therapy with topiramate tablets starting at 50 milligrams per day and be titrated to an individualized optimal dose up to a maximum of 400 milligrams per day by the end of week 6 Changes to this schedule will be based on a risk-benefit assessment of the patients clinical condition by the investigator such as tolerability or reaching a stable dose sufficient to control their seizures Treatment with topiramate will last for a total of 24 weeks The primary outcome of the study is a comparison of the mean stabilized topiramate dose during the last 28 days of treatment for patients reporting 1 to 3 seizures during the 3 months prior to study entry versus patients reporting more than 3 seizures during the 3 months prior to study entry The study hypothesis is that the average stabilized dose of topiramate will be lower in patients that have had fewer seizures in the 3 months prior to beginning the study Topiramate tablets starting at 50 milligrams per day and titrated to an individualized optimal dose up to a maximum of 400 milligrams per day by the end of week 6 Patients will take topiramate tablets by mouth twice a day morning and evening for 24 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