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
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
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
NCT ID
NCT00563459
First Posted
November 21, 2007
Last Updated
January 25, 2013
Sponsor
SK Life Science, Inc.
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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