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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
SK Life Science, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

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

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    August 29, 2008
    Last Updated
    June 10, 2013
    Sponsor
    SK Life Science, Inc.
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    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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