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.
Primary Purpose
Epilepsy, Complex Partial Seizures, Epilepsy, Complex Partial
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
carisbamate
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy focused on measuring RWJ-333369, Anticonvulsants, Antiepileptic drugs, Epilepsy, Focal, Seizure Disorder
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
001
Arm Description
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).
Outcomes
Primary Outcome Measures
Worsening of seizures, including rates of status epilepticus.
Secondary Outcome Measures
Quality of Life in Epilepsy-31-Problems (QOLIE-31-P)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00991757
Brief Title
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.
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 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 open-label extension study is to demonstrate that RWJ-333369 is safe as long-term add-on treatment of partial onset seizures.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Complex Partial Seizures, Epilepsy, Complex Partial, Epilepsies, Partial
Keywords
RWJ-333369, Anticonvulsants, Antiepileptic drugs, Epilepsy, Focal, Seizure Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
991 (Actual)
8. Arms, Groups, and Interventions
Arm Title
001
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
carisbamate
Intervention Description
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).
Primary Outcome Measure Information:
Title
Worsening of seizures, including rates of status epilepticus.
Time Frame
Up to approximately 48 months
Secondary Outcome Measure Information:
Title
Quality of Life in Epilepsy-31-Problems (QOLIE-31-P)
Time Frame
month 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
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 to Evaluate the Safety and Tolerability of RWJ 333369 as Adjunctive Therapy in Patients 16 Years and Older With Partial Onset Seizures.
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