Refractory EpilepsyPhase 2NCT00228969
Safety and Efficacy of 333369 in the Treatment of Partial Epilepsy
A Phase 2 study testing RWJ-333369 in people with Refractory Epilepsy, run by SK Life Science, Inc. at 61 sites in 8 countries.
Trial summary
The primary objective of this study is to evaluate the efficacy, safety, and tolerability of 4 daily doses of RWJ-333369 as adjunctive treatment of refractory partial epilepsy in subjects who are between 18 and 70 years of age, inclusive Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Refractory Epilepsy
- What is being tested?
- RWJ-333369
- How many people
- Not given
- Where
- 61 sitesin 8 countries
- Study dates
- Feb 2005to May 2006
- 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70 years old,
- Diagnosis of epilepsy for at least 1 year,
- Presenting, on average, at least 3 partial onset seizures per month,
- Currently treated with a stable dose (i.e., for at least 4 weeks) of no more than 3 anti-epileptic drugs (AEDs),
Who cannot join
- Have experienced status epilepticus in the past 3 months,
- Have any serious diseases,
- History of major psychiatric disorders within the past 2 years.
- Have received an experimental drug/device within the past 30 days
- Are pregnant or breastfeeding.
Trial locations and contacts
61 sites in 8 countries.
61 sites in 8 countries
United States29 sites
Study site
Baton Rouge, Louisiana
Study site
Bennington, Vermont
Study site
Birmingham, Alabama
Study site
Charlottesville, Virginia
Study site
Chesterfield, Missouri
Study site
Cincinnati, Ohio
Study site
Dallas, Texas
Study site
Decatur, Georgia
Study site
El Paso, Texas
Study site
Fort Collins, Colorado
Study site
Golden Valley, Minnesota
Study site
Huntsville, Alabama
Study site
Irvine, California
Study site
Lexington, Kentucky
Study site
Little Rock, Arkansas
Study site
Louisville, Kentucky
Study site
Madison, Wisconsin
Study site
Mobile, Alabama
Study site
Nashville, Tennessee
Study site
Northport, Alabama
Study site
Northridge, California
Study site
Philadelphia, Pennsylvania
Study site
Phoenix, Arizona
Study site
Portland, Oregon
Study site
Roanoke, Virginia
Study site
Sacramento, California
Study site
Saint Paul, Minnesota
Study site
Sellersville, Pennsylvania
Study site
Wilmington, Delaware
Poland8 sites
Study site
Gdansk
Study site
Katowice
Study site
Kielce
Study site
Krakow
Study site
Lublin
Study site
Mosina
Study site
Warsaw
Study site
Zabrze
Hungary5 sites
Study site
Budapest
Study site
Debrecen
Study site
Győr
Study site
Pécs
Study site
Zalaegerszeg-Pozva
United Kingdom5 sites
Study site
Glasgow
Study site
Middlesbrough
Study site
Northampton
Study site
Oxford
Study site
Reading
Netherlands4 sites
Study site
Breda
Study site
Heemstede
Study site
Heeze
Study site
Rotterdam
Spain4 sites
Study site
Barcelona
Study site
Madrid
Study site
Málaga
Study site
Pamplona
Argentina3 sites
Study site
Ciudad de Buenos Aires
Study site
Córdoba
Study site
Salta
About this study
The primary objective of this study is to evaluate the efficacy, safety, and tolerability of 4 daily doses of RWJ-333369 as adjunctive treatment of refractory partial epilepsy in subjects who are between 18 and 70 years of age, inclusive
- Conditions
- Refractory Epilepsy
- Being tested
- RWJ-333369
- Medical subject headings
- Drug Resistant Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RWJ-333369Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2005 (estimated)
- Study startFeb 2005
- Primary completionMay 2006
- Study completionMay 2006
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 Refractory 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
Sponsor and investigators
- Lead sponsor
- SK Life Science, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00228969
- Sponsor's protocol ID
- 333369-EPY-2003
- Status last verified
- Aug 2012
- First submitted
- 30 Jun 2005
- Last updated
- 2 Aug 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 34870321
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of 333369 in the Treatment of Partial Epilepsy
- ClinicalTrials.gov ID
- NCT00228969
- Acronym / sponsor ID
- 333369-EPY-2003
- Conditions
- Refractory Epilepsy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- SK Life Science, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2005
- Primary completion
- May 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 29 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 primary objective of this study is to evaluate the efficacy, safety, and tolerability of 4 daily doses of RWJ-333369 as adjunctive treatment of refractory partial epilepsy in subjects who are between 18 and 70 years of age, inclusive
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-70 years old,
- Diagnosis of epilepsy for at least 1 year,
- Presenting, on average, at least 3 partial onset seizures per month,
- Currently treated with a stable dose (i.e., for at least 4 weeks) of no more than 3 anti-epileptic drugs (AEDs),
Key exclusion criteria (5 listed)
- Have experienced status epilepticus in the past 3 months,
- Have any serious diseases,
- History of major psychiatric disorders within the past 2 years.
- Have received an experimental drug/device within the past 30 days
- Are pregnant or breastfeeding.
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
Not reported in the source record.
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 2 Aug 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.
Related trials for Refractory Epilepsy
Not yet recruiting
Clinical Trial of SEEG for Drug-resistant Epilepsy
Drug-Resistant Epilepsy
Recruiting
Identification of Biomarkers for Vagus Nerve Stimulation in Patients With Refractory Epilepsy
Refractory Epilepsy
Not yet recruiting
Electrophysiological Dose-Response to Anterior Thalamic Deep Brain Stimulation in Drug-Resistant Focal Epilepsy
Drug Resistant Epilepsy, Focal Epilepsy
Recruiting
Effect of Blue Light on Vagus Nerve Stimulation in Patients With Refractory Epilepsy
Refractory Epilepsy
RecruitingPhase 1
Investigation of Blood-Brain-Barrier Breakdown Using Manganese Magnetic Resonance Imaging in Drug-Resistant Epilepsy
Epilepsy
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.
The record lists no contact. Use the official record to reach the sponsor.
61 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RWJ-333369 in people with Refractory Epilepsy, run by SK Life Science, Inc. at 61 sites in 8 countries.
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 4 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 2 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 61 sites in United States, Poland, Hungary, United Kingdom, Netherlands and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00228969, 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 2 Aug 2012.