A Study of the Efficacy and Safety of RWJ-333369 as add-on Therapy in the Treatment of Partial Onset Seizures.

Tracking Information
First Submitted Date ICMJE	January 19, 2007
First Posted Date ICMJE	January 22, 2007
Last Update Posted Date	June 20, 2012
Study Start Date ICMJE	November 2006
Actual Primary Completion Date	October 2007 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: January 19, 2007)	The primary outcome is the change in seizure frequency of all simple partial motor, complex partial, or secondarily generalized seizures from the pretreatment baseline phase compared with the double-blind treatment phase.
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00425282 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: January 19, 2007)	The key secondary outcome is the change in the Seizure Severity Questionnaire score.
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	A Study of the Efficacy and Safety of RWJ-333369 as add-on Therapy in the Treatment of Partial Onset Seizures.
Official Title ICMJE	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.
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 Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Treatment
Condition ICMJE	Epilepsy; Epilepsy, Focal; Seizure Disorder; Complex Partial Seizures; Epilepsy, Complex Partial
Intervention ICMJE	Drug: RWJ-333369
Study Arms	Not Provided
Publications *	Sperling MR, Greenspan A, Cramer JA, Kwan P, Kälviäinen R, Halford JJ, Schmitt J, Yuen E, Cook T, Haas M, Novak G. Carisbamate as adjunctive treatment of partial onset seizures in adults in two randomized, placebo-controlled trials. Epilepsia. 2010 Mar;51(3):333-43. doi: 10.1111/j.1528-1167.2009.02318.x. Epub 2009 Oct 27.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: September 25, 2009)	566
Original Enrollment ICMJE; (submitted: January 19, 2007)	600
Actual Study Completion Date	October 2007
Actual Primary Completion Date	October 2007 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Male or Female, 16 year or older; Clinical diagnosis of focal epilepsy for at least 1 year; History of poor response to at least 1 anti-epileptic drug in the past; Current treatment with 1 or 2 anti-epileptic drugs; Should have at least 3 seizures per month Exclusion Criteria: Generalized epilepsy; Cannot count your seizures; Unstable medical disease, such as a recent heart attack or uncontrolled diabetes; Major psychiatric illness; Recent drug or alcohol abuse; Unable to swallow pills
Sex/Gender	Sexes Eligible for Study: All
Ages	16 Years and older (Child, Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Not Provided
Removed Location Countries	Argentina, Australia, Belgium, China, Croatia, Czech Republic, Finland, Germany, India, Korea, Republic of, Malaysia, Russian Federation, Sweden, Switzerland, United States
Administrative Information
NCT Number ICMJE	NCT00425282
Other Study ID Numbers ICMJE	CR013012
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	SK Life Science
Study Sponsor ICMJE	SK Life Science
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
PRS Account	SK Life Science
Verification Date	June 2012
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP