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
  Purpose

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.


Condition Intervention Phase
Epilepsy
Complex Partial Seizures
Epilepsy, Complex Partial
Epilepsies, Partial
Drug: carisbamate
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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: Open-Label Extension Period

Resource links provided by NLM:


Further study details as provided by SK Life Science:

Primary Outcome Measures:
  • Worsening of seizures, including rates of status epilepticus. [ Time Frame: Up to approximately 48 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of Life in Epilepsy-31-Problems (QOLIE-31-P) [ Time Frame: month 6 ] [ Designated as safety issue: No ]

Enrollment: 991
Study Start Date: February 2007
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
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).

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00991757

Sponsors and Collaborators
SK Life Science
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

No publications provided

Responsible Party: SK Life Science
ClinicalTrials.gov Identifier: NCT00991757     History of Changes
Other Study ID Numbers: 333369EPY3004
Study First Received: October 6, 2009
Last Updated: June 10, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by SK Life Science:
RWJ-333369
Anticonvulsants
Antiepileptic drugs
Epilepsy, Focal
Seizure Disorder

Additional relevant MeSH terms:
Epilepsy
Epilepsies, Partial
Seizures
Epilepsy, Complex Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 20, 2014