An Open-Label Extension Study of the Safety and Tolerability of Carisbamate as Add-On Therapy in Patients With Partial Onset Seizures

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
SK Life Science
ClinicalTrials.gov Identifier:
NCT00744731
First received: August 29, 2008
Last updated: June 10, 2013
Last verified: June 2013
  Purpose

The purpose of this study is to obtain long-term safety and tolerability information on carisbamate as add-on therapy for the treatment of partial onset seizures in patients with epilepsy. Seizure counts will be obtained to measure the rate of seizures for each patient during the study.


Condition Intervention Phase
Epilepsy, Partial, Motor
Epilepsy, Complex Partial
Epilepsy, Simple Partial
Focal Motor Epilepsy
Drug: placebo
Drug: carisbamate
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Open Label Extension Portion of the Study Entitled A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Carisbamate as Adjunctive Therapy in Subjects With Partial Onset Seizures.

Resource links provided by NLM:


Further study details as provided by SK Life Science:

Primary Outcome Measures:
  • Safety will be evaluated by 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 [ Time Frame: after a stable dose of Carisbamate is achieved, study visits to assess safety will be every three months for the duration of the subject's participation; subjects will also maintain a seizure count diary ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the impact of carisbamate on subject functioning and well being using the QOLIE-31 Patient Inventory (as exploratory). Administered at month 3 and end of study. [ Time Frame: after a stable dose of Carisbamate is achieved, study visits to assess safety will be every three months for the duration of the subject's participation; subjects will also maintain a seizure count diary ] [ Designated as safety issue: No ]

Enrollment: 403
Study Start Date: January 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 001
placebo placebo for 1 week
Drug: placebo
placebo for 1 week
Experimental: 002
carisbamate 400 mg/day to 1,200 mg per day
Drug: carisbamate
400 mg/day to 1,200 mg per day

Detailed Description:

CARISEPY3014 is the open-label extension study that follows the double-blind study CARISEPY3013 (NCT00740623). In an open label study such as CARISEPY3014, both the physician and the patient know the name of the assigned study medication. In a double blind study such as CARISEPY-3013, neither the physician nor the patient knows the name of the assigned study medication. Patients who complete the 14-week double-blind treatment phase of study CARISEPY3013 will be eligible to enter the open-label extension study during which patients will transition through a 1-week blinded period to open-label carisbamate. There will be a 1 week blinded transition during which patients will take blinded study medication; after this, patients will then take unblinded, open-label study medication. 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. The Quality of Life in Epilepsy-31 Patient Inventory questionnaire will be administered once during the study. A Medical Resource utilization questionnaire will be used to obtain cost-effectiveness information on carisbamate and will be administered twice during the study. There is no statistical testing hypothesis for this study. Carisbamate tablets taken twice daily in 2 equally divided doses, with or without food, and taken with noncarbonated water. During the first week on study, patients will take blinded transition study medication and thereafter will take a target dosage of 800 mg/day of unblinded, open-label study medication. The dosage of study medication will range from 400 to 1,200 mg/day. Patients will receive treatment for 1 year with the potential to receive treatment longer.

  Eligibility

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

Inclusion Criteria:

  • Must have completed the 14-week double-blind treatment phase of study CARISEPY3013
  • must be willing/able to follow the restrictions and prohibitions of the protocol
  • must be able to complete the patient diaries correctly (patients or legally acceptable representatives)
  • must sign an informed consent form indicating agreement to participate in the study (patients or legally acceptable representatives)
  • adolescents capable of understanding the nature of the study must provide assent to participate in the study

Exclusion Criteria:

  • Patients who have not completed the 14-week double-blind treatment phase of study CARISEPY3013.
  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: NCT00744731

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: NCT00744731     History of Changes
Other Study ID Numbers: 333369EPY3014, CARISEPY3014
Study First Received: August 29, 2008
Last Updated: June 10, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by SK Life Science:
Partial-onset Seizures
Simple Partial Seizures
Complex Partial Seizures

Additional relevant MeSH terms:
Epilepsy
Epilepsies, Partial
Epilepsy, Partial, Motor
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 26, 2014