Safety and Efficacy of 333369 in the Treatment of Partial Epilepsy
1 other identifier
interventional
N/A
8 countries
61
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Feb 2005
Shorter than P25 for phase_2
61 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2005
CompletedFirst Submitted
Initial submission to the registry
June 30, 2005
CompletedFirst Posted
Study publicly available on registry
September 29, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2006
CompletedAugust 2, 2012
August 1, 2012
1.2 years
June 30, 2005
August 1, 2012
Conditions
Interventions
Eligibility Criteria
You may qualify if:
- 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),
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (61)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Huntsville, Alabama, United States
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Mobile, Alabama, United States
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Northport, Alabama, United States
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Phoenix, Arizona, United States
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Little Rock, Arkansas, United States
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Irvine, California, United States
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Northridge, California, United States
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Sacramento, California, United States
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Fort Collins, Colorado, United States
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Wilmington, Delaware, United States
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Decatur, Georgia, United States
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Lexington, Kentucky, United States
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Louisville, Kentucky, United States
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Baton Rouge, Louisiana, United States
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Golden Valley, Minnesota, United States
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Saint Paul, Minnesota, United States
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Chesterfield, Missouri, United States
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Cincinnati, Ohio, United States
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Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Sellersville, Pennsylvania, United States
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Nashville, Tennessee, United States
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Dallas, Texas, United States
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El Paso, Texas, United States
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Bennington, Vermont, United States
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Charlottesville, Virginia, United States
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Roanoke, Virginia, United States
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Madison, Wisconsin, United States
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Ciudad de Buenos Aires, Argentina
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Córdoba, Argentina
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Salta, Argentina
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Budapest, Hungary
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Debrecen, Hungary
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Győr, Hungary
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Pécs, Hungary
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Zalaegerszeg-Pozva, Hungary
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Breda, Netherlands
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Heemstede, Netherlands
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Heeze, Netherlands
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Rotterdam, Netherlands
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Gdansk, Poland
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Katowice, Poland
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Kielce, Poland
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Krakow, Poland
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Lublin, Poland
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Mosina, Poland
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Warsaw, Poland
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Zabrze, Poland
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Moscow, Russia
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Saint Petersburg, Russia
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Samara, Russia
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Barcelona, Spain
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Madrid, Spain
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Málaga, Spain
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Pamplona, Spain
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Glasgow, United Kingdom
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Middlesbrough, United Kingdom
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Northampton, United Kingdom
Unknown Facility
Oxford, United Kingdom
Unknown Facility
Reading, United Kingdom
Related Publications (1)
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.
PMID: 34870321DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2005
First Posted
September 29, 2005
Study Start
February 1, 2005
Primary Completion
May 1, 2006
Study Completion
May 1, 2006
Last Updated
August 2, 2012
Record last verified: 2012-08