Back to resultsSafety and Efficacy of 333369 in the Treatment of Partial Epilepsy
Primary Purpose
Refractory Epilepsy
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
RWJ-333369
Sponsored by
About this trial
This is an interventional treatment trial for Refractory Epilepsy
Eligibility Criteria
Inclusion Criteria: 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), Exclusion Criteria: 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.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00228969
Brief Title
Safety and Efficacy of 333369 in the Treatment of Partial Epilepsy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
May 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SK Life Science, Inc.
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory Epilepsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
RWJ-333369
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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),
Exclusion Criteria:
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.
Facility Information:
City
Birmingham
State/Province
Alabama
Country
United States
City
Huntsville
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Alabama
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United States
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Mobile
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United States
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Northport
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Alabama
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United States
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Phoenix
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Arizona
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United States
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Little Rock
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Arkansas
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United States
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Irvine
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California
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United States
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Northridge
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California
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United States
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Sacramento
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California
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United States
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Fort Collins
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Colorado
Country
United States
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Wilmington
State/Province
Delaware
Country
United States
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Decatur
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Georgia
Country
United States
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Lexington
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Kentucky
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United States
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Louisville
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Kentucky
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United States
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Baton Rouge
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Louisiana
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United States
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Golden Valley
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Minnesota
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United States
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St. Paul
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Minnesota
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United States
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Chesterfield
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Missouri
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United States
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Cincinnati
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Ohio
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United States
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Portland
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Oregon
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United States
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Philadelphia
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Pennsylvania
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United States
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Sellersville
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Pennsylvania
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United States
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Nashville
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Tennessee
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United States
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Dallas
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Texas
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United States
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El Paso
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Texas
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United States
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Bennington
State/Province
Vermont
Country
United States
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Charlottesville
State/Province
Virginia
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United States
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Roanoke
State/Province
Virginia
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United States
City
Madison
State/Province
Wisconsin
Country
United States
City
Ciudad de Buenos Aires
Country
Argentina
City
Ciudad de Cordoba
Country
Argentina
City
Salta
Country
Argentina
City
Budapest
Country
Hungary
City
Debrecen
Country
Hungary
City
Gyor
Country
Hungary
City
Pecs
Country
Hungary
City
Zalaegerszeg-Pozva
Country
Hungary
City
Breda
Country
Netherlands
City
Heemstede
Country
Netherlands
City
Heeze
Country
Netherlands
City
Rotterdam
Country
Netherlands
City
Gdansk
Country
Poland
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Katowice
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Poland
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Kielce
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Poland
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Krakow
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Poland
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Lublin
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Poland
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Mosina
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Poland
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Warszawa
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Poland
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Zabrze
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Poland
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Moscow
Country
Russian Federation
City
Saint-Petersburg
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Russian Federation
City
Samara
Country
Russian Federation
City
Barcelona
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Spain
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Madrid
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Spain
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Malaga
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Spain
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Pamplona
Country
Spain
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Glasgow
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United Kingdom
City
Middlesbrough
Country
United Kingdom
City
Northampton
Country
United Kingdom
City
Oxford
Country
United Kingdom
City
Reading
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
34870321
Citation
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.
Results Reference
derived
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Safety and Efficacy of 333369 in the Treatment of Partial Epilepsy
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