Clinical trial NCT00228969: Safety and Efficacy of 333369 in the Treatment of Partial Epilepsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Refractory Epilepsy
Lead sponsor: SK Life Science, Inc.
Sponsor class: INDUSTRY
First posted: 2005-09-29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

1. Age 18-70 years old,
2. Diagnosis of epilepsy for at least 1 year,
3. Presenting, on average, at least 3 partial onset seizures per month,
4. Currently treated with a stable dose (i.e., for at least 4 weeks) of no more than 3 anti-epileptic drugs (AEDs),

Exclusion Criteria:

1. Have experienced status epilepticus in the past 3 months,
2. Have any serious diseases,
3. History of major psychiatric disorders within the past 2 years.
4. Have received an experimental drug/device within the past 30 days
5. Are pregnant or breastfeeding.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Huntsville
country: United States
state: Alabama
city: Mobile
country: United States
state: Alabama
city: Northport
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Irvine
country: United States
state: California
city: Northridge
country: United States
state: California
city: Sacramento
country: United States
state: California
city: Fort Collins
country: United States
state: Colorado
city: Wilmington
country: United States
state: Delaware
city: Decatur
country: United States
state: Georgia
city: Lexington
country: United States
state: Kentucky
city: Louisville
country: United States
state: Kentucky
city: Baton Rouge
country: United States
state: Louisiana
city: Golden Valley
country: United States
state: Minnesota
city: St. Paul
country: United States
state: Minnesota
city: Chesterfield
country: United States
state: Missouri
city: Cincinnati
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
city: Sellersville
country: United States
state: Pennsylvania
city: Nashville
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: El Paso
country: United States
state: Texas
city: Bennington
country: United States
state: Vermont
city: Charlottesville
country: United States
state: Virginia
city: Roanoke
country: United States
state: Virginia
city: Madison
country: United States
state: Wisconsin
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
city: Katowice
country: Poland
city: Kielce
country: Poland
city: Krakow
country: Poland
city: Lublin
country: Poland
city: Mosina
country: Poland
city: Warszawa
country: Poland
city: Zabrze
country: Poland
city: Moscow
country: Russian Federation
city: Saint-Petersburg
country: Russian Federation
city: Samara
country: Russian Federation
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Malaga
country: Spain
city: Pamplona
country: Spain
city: Glasgow
country: United Kingdom
city: Middlesbrough
country: United Kingdom
city: Northampton
country: United Kingdom
city: Oxford
country: United Kingdom
city: Reading
country: United Kingdom
Study officials:
References:
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.