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Carisbamate Retention Study (CaReS): Comparative Study on the Long Term Effectiveness, Safety and Tolerability of Carisbamate Compared to Two Other Frequently Prescribed Anti-epileptic Drugs (AEDs) in Patients With Epilepsy.

Primary Purpose

Epilepsy, Seizures

Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
carisbamate
topiramate
levetiracetam
Sponsored by
SK Life Science, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring Epilepsy, seizures, partial onset seizures, anti-epileptic drugs (AED), carisbamate, topiramate, levetiracetam

Eligibility Criteria

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

Inclusion Criteria:

  • Patients must weigh >= 45 kg (~100lbs)
  • established diagnosis, for at least 3 months prior to screening, of partial onset seizures, including simple partial motor, complex partial, or secondarily generalized seizures
  • At least 1 but no more than 120 partial onset seizures during the 3-month retrospective baseline period prior to screening
  • History of monotherapy AED treatment failure at at least 1 but not more than 4 AEDs in the past
  • Females must be postmenopausal for at least 2 years, surgically sterile, abstinent, or, if sexually active, practicing an acceptable method of birth control (eg, intrauterine device, double barrier method, male partner sterilization) before entry and throughout the study
  • Females must have a negative serum beta chorionic gonadotropin pregnancy test result at screening/randomization
  • Current AED treatment with at least 1 and no more than 2 AEDs given at a stable dose 30 days prior to screening
  • For adolescents (as defined by local regulations), a responsible person must be available to accompany the patient to the study center at each visit, to provide reliable information for the safety and effectiveness evaluations, and to accurately and reliably dispense the study drug as directed, if required in the opinion of the investigator.

Exclusion Criteria:

  • Must not have a generalized epileptic syndrome, primary generalized seizures, atonic seizures, typical or atypical absence seizures nor only simple partial type seizures with manifestations other than motor symptoms (i.e, simple partial sensory)
  • No history of unprovoked status epilepticus in the last 6 months prior to screening nor history of Lennox-Gastaut or West Syndrome
  • More than 3 days of sedative or benzodiazepine use for seizures in the 3 months months prior to screening
  • No clinical evidence of significant cardiac disease
  • ALT > 1.5 times the upper limit of normal or total bilirubin above the upper limit of normal at screen
  • No history of drug-induced liver injury, diagnosis of any form of chronic liver disease, cirrhosis, or liver cancer nor positive hepatitis serology as determined by multiantigen enzyme immunoassay (EIA)
  • No past or current with topiramate or levetiracetam for any reason
  • No current use of vagal nerve stimulator
  • No diagnosis of psychotic disorder, bipolar disease, or major depression or other neurologic conditions, serious or medically unstable systemic disease, suicidal ideation or attempts, or homicide attempts at any time in the past 2 years
  • Unable to swallow solid oral dosage forms whole with the aid of water (patients may not chew, divide, dissolve, or crush the study drug)
  • Anyone who falls under the precautions, warnings or contraindications outlined in the local topiramate and/or local levetiracetam package insert.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Active Comparator

    Arm Label

    001

    002

    003

    Arm Description

    carisbamate 400-1200 mg/day for 12 months

    topiramate 200-400mg/day for 12 months

    levetiracetam 1000-3000mg/day for 12 months

    Outcomes

    Primary Outcome Measures

    The primary efficacy endpoint is time from the first intake of study medication to discontinuation (all causes) of study medication during the 6 month core double-blind phase.

    Secondary Outcome Measures

    Cognitive side effect profiles of CRS and TPM
    Neuropsychiatric side effect profiles of CRS and LEV
    Reasons for discontinuation among the 3 treatment arms
    Seizures rates among the 3 treatment arms
    Subject reported mood states, behavioral and cognitive side effect changes among the 3 treatment arms

    Full Information

    First Posted
    November 21, 2007
    Last Updated
    January 25, 2013
    Sponsor
    SK Life Science, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00563459
    Brief Title
    Carisbamate Retention Study (CaReS): Comparative Study on the Long Term Effectiveness, Safety and Tolerability of Carisbamate Compared to Two Other Frequently Prescribed Anti-epileptic Drugs (AEDs) in Patients With Epilepsy.
    Official Title
    A Randomized, Double-Blind, Parallel-Group, Multicenter Study to Evaluate the Retention Rate, Efficacy, Safety, and Tolerability of Carisbamate, Topiramate and Levetiracetam as Adjunctive Therapy in Subjects With Partial Onset Seizures
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2013
    Overall Recruitment Status
    Terminated
    Why Stopped
    Carisbamate partial onset seizures studies lacked consistent efficacy data so trials in this indication were terminated.
    Study Start Date
    November 2007 (undefined)
    Primary Completion Date
    April 2010 (Actual)
    Study Completion Date
    April 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    SK Life Science, Inc.

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this research study is to compare the long term effectiveness, safety and tolerability of carisbamate compared to two other frequently prescribed anti-epileptic drugs (AEDs) in patients with epilepsy.
    Detailed Description
    Following a protocol amendment, this study resumed recruitment from April 10 to September 4, 2009. This is a randomized, double-blind, parallel-group, active-comparator, multi-center study. The study consists of 5 phases: pretreatment (screening), double-blind titration phase, double blind maintenance phase, a transition phase, and an open-label phase. Patients who are not eligible or choose not to enter the transition and open-label phases of the study will complete an exit phase following double-blind treatment.The primary outcome variable is long term retention rate and safety of adjunctive therapy with carisbamate vs. topiramate and levetiracetam over a six month period. This primary endpoint is a clinically meaningful measure of efficacy, safety and tolerability over time, reflecting the therapeutic effectiveness of antiepileptic drugs (AEDs). Safety evaluations including adverse event monitoring, blood tests, and vital signs will be conducted throughout the study.The hypothesis is that the 3 study medications at a minimum will have similar treatment retention rates, but based on their distinct efficacy and side effect profiles, will have discernible differences in the rates of selected adverse events and reasons for treatment discontinuation in patients with partial onset siezures. Patients must be on at least 1, but not more than 2, baseline AEDs for 30 days prior to screening. By end of week 8 patients must have reached the following minimum dosages of study drug to be permitted to continue: carisbamate 400 mg/day, topiramate 200 mg/day, or levetiracetam 1000 mg/day. Double-blind phases last approximately 12 months. Carisbamate 800 mg/day, topiramate 300 mg/day and levetiracetam 2000mg/day will be administered orally in two equally divided doses.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Epilepsy, Seizures
    Keywords
    Epilepsy, seizures, partial onset seizures, anti-epileptic drugs (AED), carisbamate, topiramate, levetiracetam

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    89 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    001
    Arm Type
    Experimental
    Arm Description
    carisbamate 400-1200 mg/day for 12 months
    Arm Title
    002
    Arm Type
    Active Comparator
    Arm Description
    topiramate 200-400mg/day for 12 months
    Arm Title
    003
    Arm Type
    Active Comparator
    Arm Description
    levetiracetam 1000-3000mg/day for 12 months
    Intervention Type
    Drug
    Intervention Name(s)
    carisbamate
    Intervention Description
    400-1200 mg/day for 12 months
    Intervention Type
    Drug
    Intervention Name(s)
    topiramate
    Intervention Description
    200-400mg/day for 12 months
    Intervention Type
    Drug
    Intervention Name(s)
    levetiracetam
    Intervention Description
    1000-3000mg/day for 12 months
    Primary Outcome Measure Information:
    Title
    The primary efficacy endpoint is time from the first intake of study medication to discontinuation (all causes) of study medication during the 6 month core double-blind phase.
    Time Frame
    A six month period
    Secondary Outcome Measure Information:
    Title
    Cognitive side effect profiles of CRS and TPM
    Time Frame
    At 6 and 12 month periods
    Title
    Neuropsychiatric side effect profiles of CRS and LEV
    Time Frame
    At 6 and 12 month periods
    Title
    Reasons for discontinuation among the 3 treatment arms
    Time Frame
    At 6 and 12 month periods
    Title
    Seizures rates among the 3 treatment arms
    Time Frame
    At 6 and 12 month periods
    Title
    Subject reported mood states, behavioral and cognitive side effect changes among the 3 treatment arms
    Time Frame
    At 6 and 12 month periods

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients must weigh >= 45 kg (~100lbs) established diagnosis, for at least 3 months prior to screening, of partial onset seizures, including simple partial motor, complex partial, or secondarily generalized seizures At least 1 but no more than 120 partial onset seizures during the 3-month retrospective baseline period prior to screening History of monotherapy AED treatment failure at at least 1 but not more than 4 AEDs in the past Females must be postmenopausal for at least 2 years, surgically sterile, abstinent, or, if sexually active, practicing an acceptable method of birth control (eg, intrauterine device, double barrier method, male partner sterilization) before entry and throughout the study Females must have a negative serum beta chorionic gonadotropin pregnancy test result at screening/randomization Current AED treatment with at least 1 and no more than 2 AEDs given at a stable dose 30 days prior to screening For adolescents (as defined by local regulations), a responsible person must be available to accompany the patient to the study center at each visit, to provide reliable information for the safety and effectiveness evaluations, and to accurately and reliably dispense the study drug as directed, if required in the opinion of the investigator. Exclusion Criteria: Must not have a generalized epileptic syndrome, primary generalized seizures, atonic seizures, typical or atypical absence seizures nor only simple partial type seizures with manifestations other than motor symptoms (i.e, simple partial sensory) No history of unprovoked status epilepticus in the last 6 months prior to screening nor history of Lennox-Gastaut or West Syndrome More than 3 days of sedative or benzodiazepine use for seizures in the 3 months months prior to screening No clinical evidence of significant cardiac disease ALT > 1.5 times the upper limit of normal or total bilirubin above the upper limit of normal at screen No history of drug-induced liver injury, diagnosis of any form of chronic liver disease, cirrhosis, or liver cancer nor positive hepatitis serology as determined by multiantigen enzyme immunoassay (EIA) No past or current with topiramate or levetiracetam for any reason No current use of vagal nerve stimulator No diagnosis of psychotic disorder, bipolar disease, or major depression or other neurologic conditions, serious or medically unstable systemic disease, suicidal ideation or attempts, or homicide attempts at any time in the past 2 years Unable to swallow solid oral dosage forms whole with the aid of water (patients may not chew, divide, dissolve, or crush the study drug) Anyone who falls under the precautions, warnings or contraindications outlined in the local topiramate and/or local levetiracetam package insert.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial
    Organizational Affiliation
    Ortho-McNeil Janssen Scientific Affairs, LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Carisbamate Retention Study (CaReS): Comparative Study on the Long Term Effectiveness, Safety and Tolerability of Carisbamate Compared to Two Other Frequently Prescribed Anti-epileptic Drugs (AEDs) in Patients With Epilepsy.

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