An Open-Label Extension Study to Evaluate the Safety and Tolerability of RWJ 333369 as Adjunctive Therapy in Patients 16 Years and Older With Partial Onset Seizures.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
SK Life Science
ClinicalTrials.gov Identifier:
NCT00991757
First received: October 6, 2009
Last updated: June 10, 2013
Last verified: June 2013

October 6, 2009
June 10, 2013
February 2007
October 2010   (final data collection date for primary outcome measure)
Worsening of seizures, including rates of status epilepticus. [ Time Frame: Up to approximately 48 months ] [ Designated as safety issue: No ]
Determine the long-term safety and tolerability of RWJ 333369 as adjunctive treatment of partial onset seizures. Safety evaluation will include worsening of seizures, including rates of status epilepticus. [ Time Frame: 1-48 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00991757 on ClinicalTrials.gov Archive Site
Quality of Life in Epilepsy-31-Problems (QOLIE-31-P) [ Time Frame: month 6 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
An Open-Label Extension Study to Evaluate the Safety and Tolerability of RWJ 333369 as Adjunctive Therapy in Patients 16 Years and Older With Partial Onset Seizures.
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: Open-Label Extension Period

The purpose of this open-label extension study is to demonstrate that RWJ-333369 is safe as long-term add-on treatment of partial onset seizures.

333369EPY3004 is the open-label extension study that follows the double-blind studies 333369EPY3001 and 333369EPY3002 (NCT00425282 and NCT00433667, respectively). In an open label study such as 333369EPY3004, both the physician and the patient know the name of the assigned study medication. In a double blind study such as 333369EPY3001 and 333369EPY3002, neither the physician nor the patient knows the name of the assigned study medication. Patients who complete the double-blind treatment phase of studies 333369EPY3001 and 333369EPY3002 will be eligible to enter the open-label extension study 333369EPY3004 during which patients will transition through a blinded period to an open-label period with carisbamate (also referred to as RWJ-333369). There will be a blinded transition during which patients will take blinded study medication; after this, patients will then take unblinded, open-label study medication. No patients will receive placebo during the open-label extension. Safety assessments include the monitoring of the frequency, severity, and timing of adverse events, clinical laboratory test results, 12-lead electrocardiogram (ECG) recordings, vital signs measurements, physical and neurologic examinations, the Physician Withdrawal Checklist for symptoms of withdrawal for those patients who taper and/or discontinue study drug, and pregnancy tests for females of childbearing potential. Seizure counts will be obtained at every visit. A Quality of Life in Epilepsy questionnaire will be administered during the study. There is no statistical testing hypothesis for this study. Detailed Description update,5 Oct 2009. The Sponsor in conjunction with the DSMB agreed to amend the protocol to withdraw patients who develop signs of a drug hypersensitivity reaction. Open-label treatment with carisbamate 400 mg/day (up to a maximum of 1200mg/day) given in 2 equally divided doses BID for up to 1 year; study drug should be swallowed whole and not be chewed, divided, crushed, or dissolved.

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Epilepsy
  • Complex Partial Seizures
  • Epilepsy, Complex Partial
  • Epilepsies, Partial
Drug: carisbamate
Open-Label Extension: 400 mg/day (up to a maximum of 1200mg/day) given in 2 equally divided doses for up to 1 year (or until carisbamate is available by prescription or the sponsor terminates the study).
Experimental: 001
carisbamate Open-Label Extension: 400 mg/day (up to a maximum of 1200mg/day) given in 2 equally divided doses for up to 1 year (or until carisbamate is available by prescription or the sponsor terminates the study).
Intervention: Drug: carisbamate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
991
October 2010
October 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • In order to enter the open label extension, the patient must have completed either Study 333369EPY3001 or Study 333369EPY3002.

Exclusion Criteria:

  • Generalized epilepsy
  • Currently experiencing seizures that cannot be counted accurately
  • Unstable medical disease, such as a recent heart attack or uncontrolled diabetes
  • Major psychiatric illness
  • Recent drug or alcohol abuse
  • Unable to swallow pills
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00991757
333369EPY3004
Not Provided
SK Life Science
SK Life Science
Not Provided
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
SK Life Science
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP