Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00266591
Status:
COMPLETED
Last Update Posted:
2011-06-08
First Post:
2005-12-16
Brief Title:
A Study of the Efficacy and Safety of Topiramate Treatment in Patients With Epilepsy
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
Single Center TOPAMAX Topiramate Monotherapy Trial in Subjects With Refractory 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 effectiveness and safety of topiramate an antiepileptic medication in patients with epilepsy
Detailed Description:
Epilepsy is a disease 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 at the same time or partial onset starting in one area of the brain Antiepileptic medications such as topiramate are selected based on a patients seizure type The specific type of seizure is not always obvious at the time of diagnosis This is a randomized double-blind parallel-group study to evaluate the effectiveness and safety of two doses of topiramate 100 or 1000 mg per day in patients with partial onset seizures The study is composed of three phases an 8-week baseline phase during which patients take their standard antiepileptic drugs a 1-week open-treatment phase during which patients continue standard antiepileptic drugs and add on topiramate 100 mgday and a double-blind treatment phase The double-blind phase is divided into two periods a 5-week conversion period and an 11-week treatment period with topiramate In the conversion period patients gradually discontinue their baseline antiepileptic drugs Those assigned to the topiramate 1000 mgday group start by taking the 100 mgday dose and gradually increase to 1000 mgday or to their maximum tolerated dose over a 5-week period Patients assigned to topiramate 100 mgday receive one 100 mg tablet plus placebo tablets to maintain the blind during the 5 week period Patients in both groups continue with their dose for the 11-week treatment period Patients are provided with diaries to record information regarding any seizures occurring during the study The primary assessment of effectiveness is the amount of time the patient receives topiramate in the double-blind treatment phase before exiting withdrawing from the study Four exit criteria for withdrawal are designed to correspond to therapeutic failure and to ensure subject safety i a doubling of the average monthly 28-day seizure frequency compared to baseline ii a doubling of the highest two-day seizure frequency that occurred during baseline iii a single generalized seizure if none occurred during the baseline phase iv or prolongation of generalized seizure duration serial seizures or status epilepticus as compared to the baseline phase seizure duration and requiring intervention Safety assessments during the study include the frequency and severity of adverse events results of clinical laboratory tests hematology biochemistry and urinalysis blood gastrin levels measurements of vital signs and body weight patient global evaluations of study drug tolerability neurologic examinations neuropsychologic tests and physical examination findings Based on the investigators judgment all patients completing the study could be enrolled into an open-label extension phase during which patients know the identity and dose of topiramate The study hypothesis is that the 1000 mgday dose of topiramate is superior to the 100 mgday dose in the amount of time before patients exit withdraw based on pre-established exit criteria corresponding to therapeutic failure from the double-blind phase 100 mgday group one Topiramate 100 mg oral tablet plus placebo tablets to maintain the blind for 16 weeks 1000 mgday group starting with one Topiramate 100 mg oral tablet and gradually increasing to 1000 mgday or maximum tolerated dose over 5 weeks and continuing that dose for 11 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