Epilepsy, Partial, MotorPhase 3NCT00744731
An Open-Label Extension Study of the Safety and Tolerability of Carisbamate as Add-On Therapy in Patients With Partial Onset Seizures
A Phase 3 study testing carisbamate in people with Epilepsy, Partial, Motor and Epilepsy, Complex Partial, run by SK Life Science, Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Epilepsy, Partial, Motor, Epilepsy, Complex Partial, Epilepsy, Simple Partial
- What is being tested?
- carisbamate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 403 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Aug 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
- 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
Who cannot join
- Patients who have not completed the 14-week double-blind treatment phase of study CARISEPY3013.
About this study
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.
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.
Read the 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.
- Conditions
- Epilepsy, Partial, Motor, Epilepsy, Complex Partial, Epilepsy, Simple Partial, Focal Motor Epilepsy
- Being tested
- placebo, carisbamate
- Keywords
- Partial-onset Seizures, Simple Partial Seizures, Complex Partial Seizures
- Medical subject headings
- Epilepsy, Partial, Motor, Epilepsy, Complex Partial, Epilepsies, Partial, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
placebo for 1 week
carisbamateDrug
400 mg/day to 1,200 mg per day
| Study group | Role | What they receive |
|---|---|---|
| 001 | Experimental | placebo placebo for 1 week Receives: Drug: placebo |
| 002 | Experimental | carisbamate 400 mg/day to 1,200 mg per day Receives: Drug: carisbamate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 outcomes (1)
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2008 (estimated)
- Study startJan 2009
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsy, Partial, MotorStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 403 participants (actual)
Sponsor and investigators
- Lead sponsor
- SK Life Science, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00744731
- Sponsor's protocol ID
- 333369EPY3014
- Other IDs
- CARISEPY3014
- Status last verified
- Jun 2013
- First submitted
- 29 Aug 2008
- Last updated
- 18 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00744731
- Acronym / sponsor ID
- 333369EPY3014
- Conditions
- Epilepsy, Partial, Motor, Epilepsy, Complex Partial, Epilepsy, Simple Partial, Focal Motor Epilepsy
- Keywords
- Partial-onset Seizures, Simple Partial Seizures, Complex Partial Seizures
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 403 participants (actual)
- Lead sponsor
- SK Life Science, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 1 Sep 2008 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 001 | Experimental | Drug: placeboplacebo placebo for 1 week |
| 002 | Experimental | Drug: carisbamatecarisbamate 400 mg/day to 1,200 mg per day |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Patients who have not completed the 14-week double-blind treatment phase of study CARISEPY3013.
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 |
|---|---|---|
| placeboplacebo for 1 week | Drug | 001 |
| carisbamate400 mg/day to 1,200 mg per day | Drug | 002 |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 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.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing carisbamate in people with Epilepsy, Partial, Motor and Epilepsy, Complex Partial, 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 5 inclusion and 1 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: finished, as of the sponsor's last update on 18 Jun 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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). 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 18 Jun 2013.