EpilepsyPhase 2NCT00210522
An Open-Label Extension Study of the Effectiveness and Safety of the Investigational Compound RWJ-333369 in Patients With Epilepsy
A Phase 2 study testing RWJ 333369 in people with Epilepsy and Epilepsies, Partial, run by SK Life Science, Inc..
Trial summary
The purpose of this study is to evaluate the effectiveness and safety of the novel compound RWJ-333369 in reducing the frequency of seizures in patients with epilepsy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Epilepsy, Epilepsies, Partial
- What is being tested?
- RWJ 333369
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 421 participants
- Where
- No sites listed yet
- Study dates
- May 2005to Jun 2010
- Phase
- Phase 2
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must complete Visit 8 (Day 112) of the double-blind treatment phase of Study EPY-2003 to be eligible for entry into the open-label treatment phase of Study EPY-2006.
Who cannot join
- Patients who have seizures that cannot be quantitated accurately
- Patients with a history of nonepileptic seizures, serious systemic disease, progressive neurologic disorder, a major psychiatric disorder, status epilepticus in the past 3 months, vagal nerve stimulation discontinuation within the past 3 months
- Patients with a history of drug or alcohol abuse within the past 2 years
- Patients currently taking felbamate, vigabatrin, or tricyclic antidepressants
- and patients who are pregnant or nursing.
About this study
Official title: A Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy, Safety, and Tolerability of RWJ-333369 as Adjunctive Therapy in Subjects With Refractory Partial Seizures (Protocol 333369-EPY-2003 [Double-blind] and Protocol 333369-EPY-2006 [Open-label Extension])
The purpose of this study is to evaluate the effectiveness and safety of the novel compound RWJ-333369 in reducing the frequency of seizures in patients with epilepsy.
Read the detailed description
333369EPY2006 is the open-label extension study that follows the double-blind study 333369EPY2003. In an open label study such as 333369EPY2006, both the physician and the patient know the name of the assigned study medication. In a double blind study such as 333369EPY2003, neither the physician nor the patient knows the name of the assigned study medication. Patients who complete the double-blind treatment phase of study 333369EPY2003 will be eligible to enter the open-label extension study during which patients will transition through a blinded period to an open-label period with carisbamate (also referred to as RWJ-333369). RWJ-333369 is a new chemical compound with anticonvulsant activity that is currently under investigation as a treatment for epilepsy. Patients electing to enter the open-label extension phase will be supplied with both open-label carisbamate (RWJ-333369) and blinded study medication for the transition phase. During this transition phase (approximately 3 weeks in length), the patient's dose of double-blind study drug will be gradually reduced and stopped and treatment with open-label RWJ-333369 will be started. Throughout the remainder of the open label extension phase, investigators will be allowed to make further adjustments of the dosage and schedule of carisbamate, including independent adjustment of the morning and evening doses, but a dosage of 1,200 mg/day may not be exceeded and increases in dosage must be in increments of no more than 200 mg/day. After 12 months of participation in the open-label extension study, patients who, in the judgment of the investigator, continue to benefit from treatment with RWJ-333369 may continue to receive the drug with follow up clinic visits every 3 months until RWJ 333369 is available by prescription or the program is terminated by the sponsor. RWJ-333369 (100, 300, 800, or 1,600 milligrams per day) administered orally in 2 equally divided doses for up to 16 weeks of double-blind treatment followed by the option to continue RWJ-333369 treatment in an open-label study for at least 1 year, then until drug is available or production ceases.
- Conditions
- Epilepsy, Epilepsies, Partial
- Being tested
- RWJ 333369
- Keywords
- RWJ-333369, Anticonvulsants, Epilepsy, Refractory partial epilepsy, Seizure disorder, Antiepileptic drugs
- Medical subject headings
- Epilepsy, Epilepsies, Partial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RWJ 333369Drug
Open-Label Extension: One 200 mg to 600mg tablet taken twice daily (up to a maximum of 1200mg/day) up to 1 year or the time that RWJ-333369 is available by prescription or the study is terminated by Sponsor.
| Study group | Role | What they receive |
|---|---|---|
| 001 | Experimental | RWJ 333369 Open-Label Extension: One 200 mg to 600mg tablet taken twice daily (up to a maximum of 1200mg/day) up to 1 year or the time that RWJ-333369 is available by prescription or the study is terminated by Sponsor. Receives: Drug: RWJ 333369 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Measured: Up to 1 year or until carisbamate is available by prescription or the study is terminated by the sponsor
Clinical laboratory test values
Measured: Up to 1 year or until carisbamate is available by prescription or the study is terminated by the sponsor
12-lead ECG recordings
Measured: Up to 1 year or until carisbamate is available by prescription or the study is terminated by the sponsor
Vital sign measurements
Measured: Up to 1 year or until carisbamate is available by prescription or the study is terminated by the sponsor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startMay 2005
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 421 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
- NCT00210522
- Sponsor's protocol ID
- CR002191
- Status last verified
- Jan 2013
- First submitted
- 13 Sep 2005
- Last updated
- 24 Jan 2013
- Results posted
- No
Publications
Faught E, Holmes GL, Rosenfeld WE, Novak G, Neto W, Greenspan A, Schmitt J, Yuen E, Reines S, Haas M. Randomized, controlled, dose-ranging trial of carisbamate for partial-onset seizures. Neurology. 2008 Nov 11;71(20):1586-93. doi: 10.1212/01.wnl.0000334751.89859.7f.
PubMed 19001248
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy, Safety, and Tolerability of RWJ-333369 as Adjunctive Therapy in Subjects With Refractory Partial Seizures (Protocol 333369-EPY-2003 [Double-blind] and Protocol 333369-EPY-2006 [Open-label Extension])
- ClinicalTrials.gov ID
- NCT00210522
- Acronym / sponsor ID
- CR002191
- Conditions
- Epilepsy, Epilepsies, Partial
- Keywords
- RWJ-333369, Anticonvulsants, Epilepsy, Refractory partial epilepsy, Seizure disorder, Antiepileptic drugs
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 421 participants (actual)
- Lead sponsor
- SK Life Science, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2005
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 21 Sep 2005 (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 evaluate the effectiveness and safety of the novel compound RWJ-333369 in reducing the frequency of seizures in patients with epilepsy.
Detailed description
333369EPY2006 is the open-label extension study that follows the double-blind study 333369EPY2003. In an open label study such as 333369EPY2006, both the physician and the patient know the name of the assigned study medication. In a double blind study such as 333369EPY2003, neither the physician nor the patient knows the name of the assigned study medication. Patients who complete the double-blind treatment phase of study 333369EPY2003 will be eligible to enter the open-label extension study during which patients will transition through a blinded period to an open-label period with carisbamate (also referred to as RWJ-333369). RWJ-333369 is a new chemical compound with anticonvulsant activity that is currently under investigation as a treatment for epilepsy. Patients electing to enter the open-label extension phase will be supplied with both open-label carisbamate (RWJ-333369) and blinded study medication for the transition phase. During this transition phase (approximately 3 weeks in length), the patient's dose of double-blind study drug will be gradually reduced and stopped and treatment with open-label RWJ-333369 will be started. Throughout the remainder of the open label extension phase, investigators will be allowed to make further adjustments of the dosage and schedule of carisbamate, including independent adjustment of the morning and evening doses, but a dosage of 1,200 mg/day may not be exceeded and increases in dosage must be in increments of no more than 200 mg/day. After 12 months of participation in the open-label extension study, patients who, in the judgment of the investigator, continue to benefit from treatment with RWJ-333369 may continue to receive the drug with follow up clinic visits every 3 months until RWJ 333369 is available by prescription or the program is terminated by the sponsor. RWJ-333369 (100, 300, 800, or 1,600 milligrams per day) administered orally in 2 equally divided doses for up to 16 weeks of double-blind treatment followed by the option to continue RWJ-333369 treatment in an open-label study for at least 1 year, then until drug is available or production ceases.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 001 | Experimental | Drug: RWJ 333369RWJ 333369 Open-Label Extension: One 200 mg to 600mg tablet taken twice daily (up to a maximum of 1200mg/day) up to 1 year or the time that RWJ-333369 is available by prescription or the study is terminated by Sponsor. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients must complete Visit 8 (Day 112) of the double-blind treatment phase of Study EPY-2003 to be eligible for entry into the open-label treatment phase of Study EPY-2006.
Key exclusion criteria (5 listed)
- Patients who have seizures that cannot be quantitated accurately
- Patients with a history of nonepileptic seizures, serious systemic disease, progressive neurologic disorder, a major psychiatric disorder, status epilepticus in the past 3 months, vagal nerve stimulation discontinuation within the past 3 months
- Patients with a history of drug or alcohol abuse within the past 2 years
- Patients currently taking felbamate, vigabatrin, or tricyclic antidepressants
- and patients who are pregnant or nursing.
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 333369Open-Label Extension: One 200 mg to 600mg tablet taken twice daily (up to a maximum of 1200mg/day) up to 1 year or the time that RWJ-333369 is available by prescription or the study is terminated by Sponsor. | Drug | 001 |
Primary outcome
Adverse events
Time frame: Up to 1 year or until carisbamate is available by prescription or the study is terminated by the sponsor
Clinical laboratory test values
Time frame: Up to 1 year or until carisbamate is available by prescription or the study is terminated by the sponsor
12-lead ECG recordings
Time frame: Up to 1 year or until carisbamate is available by prescription or the study is terminated by the sponsor
Vital sign measurements
Time frame: Up to 1 year or until carisbamate is available by prescription or the study is terminated by the sponsor
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 24 Jan 2013.
- Derived from this study: PubMed 19001248Faught E, Holmes GL, Rosenfeld WE, Novak G, Neto W, Greenspan A, Schmitt J, Yuen E, Reines S, Haas M. Randomized, controlled, dose-ranging trial of carisbamate for partial-onset seizures. Neurology. 2008 Nov 11;71(20):1586-93. doi: 10.1212/01.wnl.0000334751.89859.7f.
Related trials for Epilepsy
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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 2 study testing RWJ 333369 in people with Epilepsy and Epilepsies, 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 1 inclusion and 5 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 24 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Adverse events (time frame: Up to 1 year or until carisbamate is available by prescription or the study is terminated by the sponsor). The study lists 4 primary outcomes in all. 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 NCT00210522, which also lists 1 linked publication.
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 24 Jan 2013.