An Open-Label Extension Study of the Safety and Tolerability of Carisbamate as Add-On Therapy in Patients With Partial Onset Seizures
Primary Purpose
Epilepsy, Partial, Motor, Epilepsy, Complex Partial, Epilepsy, Simple Partial
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
placebo
carisbamate
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy, Partial, Motor focused on measuring Partial-onset Seizures, Simple Partial Seizures, Complex Partial Seizures
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
001
002
Arm Description
placebo placebo for 1 week
carisbamate 400 mg/day to 1,200 mg per day
Outcomes
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00744731
Brief Title
An Open-Label Extension Study of the Safety and Tolerability of Carisbamate as Add-On Therapy in Patients With Partial Onset Seizures
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.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SK Life Science, Inc.
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Partial, Motor, Epilepsy, Complex Partial, Epilepsy, Simple Partial, Focal Motor Epilepsy
Keywords
Partial-onset Seizures, Simple Partial Seizures, Complex Partial Seizures
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
403 (Actual)
8. Arms, Groups, and Interventions
Arm Title
001
Arm Type
Experimental
Arm Description
placebo placebo for 1 week
Arm Title
002
Arm Type
Experimental
Arm Description
carisbamate 400 mg/day to 1,200 mg per day
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo for 1 week
Intervention Type
Drug
Intervention Name(s)
carisbamate
Intervention Description
400 mg/day to 1,200 mg per day
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Organizational Affiliation
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
An Open-Label Extension Study of the Safety and Tolerability of Carisbamate as Add-On Therapy in Patients With Partial Onset Seizures
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