Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00210652
Status:
COMPLETED
Last Update Posted:
2013-01-24
First Post:
2005-09-13
Brief Title:
An Open-Label Extension Study to Evaluate the Safety and Effectiveness of 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-Titration Study to Determine Safety Tolerability and Preliminary Efficacy of RWJ-333369 as Adjunctive Therapy in Subjects With Treatment-Resistant Partial Seizures With or Without Secondary Generalization or Primarily Generalized Tonic-Clonic Seizures
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 safety and preliminary effectiveness of the novel compound RWJ-333369 in patients with partial onset seizures who are currently being treated with 1 or 2 concomitant antiepileptic drugs
Detailed Description:
333369EPY2002 is the open-label extension study that follows the double-blind study 333369EPY2001 In an open label study such as 333369EPY2002 both the physician and the patient know the name of the assigned study medication In a double blind study such as 333369EPY2001 neither the physician nor the patient knows the name of the assigned study medication Patients who complete the double-blind treatment phase of study 333369EPY2001 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 up to 21 days 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 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 Initial dose RWJ-333369 is 1 capsule 250 milligram mg taken twice daily Dosage may be changed at weekly intervals The maximum permitted dose will be 4 capsules 1000 mg twice daily during dose titration Double blind-treatment duration is up to 71 days with the option to continue treatment in an open-label study Maximum dose in open-label study is 1200 mgday
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