EpilepsyPhase 3NCT00433667
A Study of the Efficacy and Safety of RWJ-333369 as add-on Therapy in the Treatment of Partial Onset Seizures.
A Phase 3 study testing RWJ-333369 in people with Epilepsy and Epilepsy, Focal, run by SK Life Science, Inc..
Trial summary
The purpose of this study is to demonstrate that RWJ-333369 is safe and effective as add-on treatment of partial onset seizures. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Epilepsy, Epilepsy, Focal, Seizure Disorder
- What is being tested?
- RWJ-333369
- How many people
- 563 participants
- Where
- No sites listed yet
- Study dates
- Nov 2006to Oct 2007
- 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
- Male or Female, 16 year or older
- Clinical diagnosis of focal epilepsy for at least 1 year
- History of poor response to at least 1 anti-epileptic drug in the past
- Current treatment with 1 or 2 anti-epileptic drugs
- Should have at least 3 seizures per month
Who cannot join
- Generalized epilepsy
- Cannot count your seizures
- Unstable medical disease, such as a recent heart attack or uncontrolled diabetes
- Major psychiatric illness
- Recent drug or alcohol abuse
- Unable to swallow pills
About this study
Official title: Epilepsy Phase III Trial
The purpose of this study is to demonstrate that RWJ-333369 is safe and effective as add-on treatment of partial onset seizures.
Read the detailed description
According to the World Health Organization (WHO), epilepsy afflicts more than 50 million people worldwide. Despite the ongoing use of older antiepileptic drugs (AEDs) and the development of newer treatments that are better tolerated, approximately 30% of patients, particularly those with partial seizures, are not well controlled even on newer treatments, or experience significant side effects from treatment. RWJ-333369 is a drug with anticonvulsant activity that is being investigated for the treatment of epilepsy. This is a randomized (patients are assigned different treatments based on chance), double-blind study (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage ) in males and females who have partial onset seizures that have had an inadequate response to at least one AED. The study consists of 3 phases: pretreatment (a screening visit and a 56-day baseline period), double-blind treatment (12 weeks of treatment with either 200 mg per day of RWJ-333369, 400 mg per day of RWJ-333369, or placebo), and posttreatment (a posttreatment visit that occurs 7 to 14 days after the last dose of double-blind study drug). The posttreatment phase is only for patients not continuing in the open-label extension study. The open-label extension study is offered after completion of the double-blind treatment phase if the study doctor judges that the patient may benefit from continued treatment with RWJ-333369. The open-label extension study lasts until RWJ-333369 becomes available by prescription or its development is stopped by the sponsor. The efficacy of the RWJ-333369 will be based on a change in the frequency and severity of seizures. Safety assessments include adverse events (side effects) reporting, collecting blood tests and Electrocardiograms and performing physical exams, including vitals signs. The study hypothesis is that 400 mg per day of RWJ-333369 is better than placebo as add-on treatment of partial onset seizures, as measured by the percent reduction from baseline in the monthly partial onset seizure frequency. 200 mg per day RWJ-333369, 400 mg per day RWJ-333369, or placebo, given twice daily with or without food approximately 12 hours apart; study drug should be swallowed whole and not be chewed, divided, crushed, or dissolved.
- Conditions
- Epilepsy, Epilepsy, Focal, Seizure Disorder, Complex Partial Seizures, Epilepsy, Complex Partial
- Being tested
- RWJ-333369
- Keywords
- RWJ-333369, anticonvulsants, antiepileptic drugs
- Medical subject headings
- Epilepsy, Epilepsies, Partial, Seizures, Epilepsy, Complex Partial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RWJ-333369Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is the change in seizure frequency of all simple partial motor, complex partial, or secondarily generalized seizures from the pretreatment baseline phase compared with the double-blind treatment phase.
Secondary outcomes (1)
The key secondary outcome is the change in the Seizure Severity Questionnaire score.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2007 (estimated)
- Study startNov 2006
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Double blind
- Enrolment
- 563 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
- NCT00433667
- Sponsor's protocol ID
- CR010357
- Status last verified
- Jun 2012
- First submitted
- 9 Feb 2007
- Last updated
- 18 Jun 2012
- Results posted
- No
Publications
Lu C, Zheng J, Cao Y, Bresnahan R, Martin-McGill KJ. Carisbamate add-on therapy for drug-resistant focal epilepsy. Cochrane Database Syst Rev. 2021 Dec 6;12(12):CD012121. doi: 10.1002/14651858.CD012121.pub2.
PubMed 34870321Sperling MR, Greenspan A, Cramer JA, Kwan P, Kalviainen R, Halford JJ, Schmitt J, Yuen E, Cook T, Haas M, Novak G. Carisbamate as adjunctive treatment of partial onset seizures in adults in two randomized, placebo-controlled trials. Epilepsia. 2010 Mar;51(3):333-43. doi: 10.1111/j.1528-1167.2009.02318.x. Epub 2009 Oct 27.
PubMed 19863578
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epilepsy Phase III Trial
- ClinicalTrials.gov ID
- NCT00433667
- Acronym / sponsor ID
- CR010357
- Conditions
- Epilepsy, Epilepsy, Focal, Seizure Disorder, Complex Partial Seizures, Epilepsy, Complex Partial
- Keywords
- RWJ-333369, anticonvulsants, antiepileptic drugs
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 563 participants (actual)
- Lead sponsor
- SK Life Science, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 12 Feb 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 study is to demonstrate that RWJ-333369 is safe and effective as add-on treatment of partial onset seizures.
Detailed description
According to the World Health Organization (WHO), epilepsy afflicts more than 50 million people worldwide. Despite the ongoing use of older antiepileptic drugs (AEDs) and the development of newer treatments that are better tolerated, approximately 30% of patients, particularly those with partial seizures, are not well controlled even on newer treatments, or experience significant side effects from treatment. RWJ-333369 is a drug with anticonvulsant activity that is being investigated for the treatment of epilepsy. This is a randomized (patients are assigned different treatments based on chance), double-blind study (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage ) in males and females who have partial onset seizures that have had an inadequate response to at least one AED. The study consists of 3 phases: pretreatment (a screening visit and a 56-day baseline period), double-blind treatment (12 weeks of treatment with either 200 mg per day of RWJ-333369, 400 mg per day of RWJ-333369, or placebo), and posttreatment (a posttreatment visit that occurs 7 to 14 days after the last dose of double-blind study drug). The posttreatment phase is only for patients not continuing in the open-label extension study. The open-label extension study is offered after completion of the double-blind treatment phase if the study doctor judges that the patient may benefit from continued treatment with RWJ-333369. The open-label extension study lasts until RWJ-333369 becomes available by prescription or its development is stopped by the sponsor. The efficacy of the RWJ-333369 will be based on a change in the frequency and severity of seizures. Safety assessments include adverse events (side effects) reporting, collecting blood tests and Electrocardiograms and performing physical exams, including vitals signs. The study hypothesis is that 400 mg per day of RWJ-333369 is better than placebo as add-on treatment of partial onset seizures, as measured by the percent reduction from baseline in the monthly partial onset seizure frequency. 200 mg per day RWJ-333369, 400 mg per day RWJ-333369, or placebo, given twice daily with or without food approximately 12 hours apart; study drug should be swallowed whole and not be chewed, divided, crushed, or dissolved.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
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)
- Male or Female, 16 year or older
- Clinical diagnosis of focal epilepsy for at least 1 year
- History of poor response to at least 1 anti-epileptic drug in the past
- Current treatment with 1 or 2 anti-epileptic drugs
- Should have at least 3 seizures per month
Key exclusion criteria (6 listed)
- Generalized epilepsy
- Cannot count your seizures
- Unstable medical disease, such as a recent heart attack or uncontrolled diabetes
- Major psychiatric illness
- Recent drug or alcohol abuse
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 |
|---|---|---|
| RWJ-333369 | Drug | – |
Primary outcome
The primary outcome is the change in seizure frequency of all simple partial motor, complex partial, or secondarily generalized seizures from the pretreatment baseline phase compared with the double-blind treatment phase.
1 secondary outcome
The key secondary outcome is the change in the Seizure Severity Questionnaire score.
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 2012.
- Derived from this study: PubMed 34870321Lu C, Zheng J, Cao Y, Bresnahan R, Martin-McGill KJ. Carisbamate add-on therapy for drug-resistant focal epilepsy. Cochrane Database Syst Rev. 2021 Dec 6;12(12):CD012121. doi: 10.1002/14651858.CD012121.pub2.
- Derived from this study: PubMed 19863578Sperling MR, Greenspan A, Cramer JA, Kwan P, Kalviainen R, Halford JJ, Schmitt J, Yuen E, Cook T, Haas M, Novak G. Carisbamate as adjunctive treatment of partial onset seizures in adults in two randomized, placebo-controlled trials. Epilepsia. 2010 Mar;51(3):333-43. doi: 10.1111/j.1528-1167.2009.02318.x. Epub 2009 Oct 27.
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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 RWJ-333369 in people with Epilepsy and Epilepsy, Focal, 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 6 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 2012. 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?
The primary outcome is the change in seizure frequency of all simple partial motor, complex partial, or secondarily generalized seizures from the pretreatment baseline phase compared with the double-blind treatment phase.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00433667, which also lists 2 linked publications.
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 2012.