Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00210522
Status:
COMPLETED
Last Update Posted:
2013-01-24
First Post:
2005-09-13
Brief Title:
An Open-Label Extension Study of the Effectiveness and Safety of the Investigational Compound RWJ-333369 in Patients With Epilepsy
Sponsor:
SK Life Science Inc
Organization:
SK Life Science Inc
Study Overview
Official Title:
A Double-Blind Placebo-Controlled Dose-Ranging Study to Evaluate the Efficacy Safety and Tolerability of RWJ-333369 as Adjunctive Therapy in Subjects With Refractory Partial Seizures Protocol 333369-EPY-2003 Double-blind and Protocol 333369-EPY-2006 Open-label Extension
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
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 the novel compound RWJ-333369 in reducing the frequency of seizures in patients with epilepsy
Detailed Description:
333369EPY2006 is the open-label extension study that follows the double-blind study 333369EPY2003 In an open label study such as 333369EPY2006 both the physician and the patient know the name of the assigned study medication In a double blind study such as 333369EPY2003 neither the physician nor the patient knows the name of the assigned study medication Patients who complete the double-blind treatment phase of study 333369EPY2003 will be eligible to enter the open-label extension study during which patients will transition through a blinded period to an open-label period with carisbamate also referred to as RWJ-333369 RWJ-333369 is a new chemical compound with anticonvulsant activity that is currently under investigation as a treatment for epilepsy Patients electing to enter the open-label extension phase will be supplied with both open-label carisbamate RWJ-333369 and blinded study medication for the transition phase During this transition phase approximately 3 weeks in length the patients dose of double-blind study drug will be gradually reduced and stopped and treatment with open-label RWJ-333369 will be started Throughout the remainder of the open label extension phase investigators will be allowed to make further adjustments of the dosage and schedule of carisbamate including independent adjustment of the morning and evening doses but a dosage of 1200 mgday may not be exceeded and increases in dosage must be in increments of no more than 200 mgday After 12 months of participation in the open-label extension study patients who in the judgment of the investigator continue to benefit from treatment with RWJ-333369 may continue to receive the drug with follow up clinic visits every 3 months until RWJ 333369 is available by prescription or the program is terminated by the sponsor RWJ-333369 100 300 800 or 1600 milligrams per day administered orally in 2 equally divided doses for up to 16 weeks of double-blind treatment followed by the option to continue RWJ-333369 treatment in an open-label study for at least 1 year then until drug is available or production ceases
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