Ignite Creation Date:
2024-05-05 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00425282
Status:
COMPLETED
Last Update Posted:
2012-06-20
First Post:
2007-01-19
Brief Title:
A Study of the Efficacy and Safety of RWJ-333369 as add-on Therapy in the Treatment of Partial Onset Seizures
Sponsor:
SK Life Science Inc
Organization:
SK Life Science Inc
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Parallel Group Multicenter Study to Evaluate the Efficacy Safety and Tolerability of RWJ-333369 as Adjunctive Therapy in Subjects With Partial Onset Seizures Followed by an Open-Label Extension Study
Status:
COMPLETED
Status Verified Date:
2012-06
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 demonstrate that RWJ-333369 is safe and effective as add-on treatment of partial onset seizures
Detailed Description:
According to the World Health Organization WHO epilepsy afflicts more than 50 million people worldwide Despite the ongoing use of older antiepileptic drugs AEDs and the development of newer treatments that are better tolerated approximately 30 of patients particularly those with partial seizures are not well controlled even on newer treatments or experience significant side effects from treatment RWJ-333369 is a drug with anticonvulsant activity that is being investigated for the treatment of epilepsy This is a randomized patients are assigned different treatments based on chance double-blind study neither the patient nor the physician knows whether drug or placebo is being taken or at what dosage in males and females who have partial onset seizures that have had an inadequate response to at least one AED The study consists of 3 phases pretreatment a screening visit and a 56-day baseline period double-blind treatment 12 weeks of treatment with either 200 mg per day of RWJ-333369 400 mg per day of RWJ-333369 or placebo and posttreatment a posttreatment visit that occurs 7 to 14 days after the last dose of double-blind study drug The posttreatment phase is only for patients not continuing in the open-label extension study The open-label extension study is offered after completion of the double-blind treatment phase if the study doctor judges that the patient may benefit from continued treatment with RWJ-333369 The open-label extension study lasts until RWJ-333369 becomes available by prescription or its development is stopped by the sponsor The efficacy of the RWJ-333369 will be based on a change in the frequency and severity of seizures Safety assessments include adverse events side effects reporting collecting blood tests and Electrocardiograms and performing physical exams including vitals signs The study hypothesis is that 400 mg per day of RWJ-333369 is better than placebo as add-on treatment of partial onset seizures as measured by the percent reduction from baseline in the monthly partial onset seizure frequency 200 mg per day RWJ-333369 400 mg per day RWJ-333369 or placebo given twice daily with or without food approximately 12 hours apart study drug should be swallowed whole and not be chewed divided crushed or dissolved
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