EpilepsyPhase 3NCT00563459
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.
A Phase 3 study testing carisbamate, topiramate and levetiracetam in people with Epilepsy and Seizures, run by SK Life Science, Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- What is being tested?
- carisbamate, topiramate and levetiracetam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- No sites listed yet
- Study dates
- Nov 2007to Apr 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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.
About this study
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
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.
Read the 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.
- Being tested
- carisbamate, topiramate, levetiracetam
- Keywords
- Epilepsy, seizures, partial onset seizures, anti-epileptic drugs (AED), carisbamate, topiramate, levetiracetam
- Medical subject headings
- Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carisbamateDrug
400-1200 mg/day for 12 months
topiramateDrug
200-400mg/day for 12 months
levetiracetamDrug
1000-3000mg/day for 12 months
| Study group | Role | What they receive |
|---|---|---|
| 001 | Experimental | carisbamate 400-1200 mg/day for 12 months Receives: Drug: carisbamate |
| 002 | Active comparator | topiramate 200-400mg/day for 12 months Receives: Drug: topiramate |
| 003 | Active comparator | levetiracetam 1000-3000mg/day for 12 months Receives: Drug: levetiracetam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: A six month period
Secondary outcomes (5)
Cognitive side effect profiles of CRS and TPM
Measured: At 6 and 12 month periods
Neuropsychiatric side effect profiles of CRS and LEV
Measured: At 6 and 12 month periods
Reasons for discontinuation among the 3 treatment arms
Measured: At 6 and 12 month periods
Seizures rates among the 3 treatment arms
Measured: At 6 and 12 month periods
Subject reported mood states, behavioral and cognitive side effect changes among the 3 treatment arms
Measured: At 6 and 12 month periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionApr 2010
- Study completionApr 2010
Why it stopped: Carisbamate partial onset seizures studies lacked consistent efficacy data so trials in this indication were terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- SK Life Science, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial, Study director, Ortho-McNeil Janssen Scientific Affairs, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00563459
- Sponsor's protocol ID
- CR014317
- Other IDs
- Carisbamate Retention Study, CaReS, EudraCT # 2007-02929-78, CARISEPY3007
- Status last verified
- Jan 2013
- First submitted
- 21 Nov 2007
- Last updated
- 29 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00563459
- Acronym / sponsor ID
- CR014317
- Keywords
- Epilepsy, seizures, partial onset seizures, anti-epileptic drugs (AED), carisbamate, topiramate, levetiracetam
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Carisbamate partial onset seizures studies lacked consistent efficacy data so trials in this indication were terminated.
- Enrolment
- 89 participants (actual)
- Lead sponsor
- SK Life Science, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 26 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 001 | Experimental | Drug: carisbamatecarisbamate 400-1200 mg/day for 12 months |
| 002 | Active comparator | Drug: topiramatetopiramate 200-400mg/day for 12 months |
| 003 | Active comparator | Drug: levetiracetamlevetiracetam 1000-3000mg/day for 12 months |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| carisbamate400-1200 mg/day for 12 months | Drug | 001 |
| topiramate200-400mg/day for 12 months | Drug | 002 |
| levetiracetam1000-3000mg/day for 12 months | Drug | 003 |
Primary outcome
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
5 secondary outcomes
Cognitive side effect profiles of CRS and TPM
Time frame: At 6 and 12 month periods
Neuropsychiatric side effect profiles of CRS and LEV
Time frame: At 6 and 12 month periods
Reasons for discontinuation among the 3 treatment arms
Time frame: At 6 and 12 month periods
Seizures rates among the 3 treatment arms
Time frame: At 6 and 12 month periods
Subject reported mood states, behavioral and cognitive side effect changes among the 3 treatment arms
Time frame: At 6 and 12 month periods
Results and safety
The study was stopped early (reason given: Carisbamate partial onset seizures studies lacked consistent efficacy data so trials in this indication were terminated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial study director
Ortho-McNeil Janssen Scientific Affairs, LLC
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing carisbamate, topiramate and levetiracetam in people with Epilepsy and Seizures, run by SK Life Science, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Carisbamate partial onset seizures studies lacked consistent efficacy data so trials in this indication were terminated.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2013.