Safety and Efficacy of 333369 in the Treatment of Partial Epilepsy

• Sponsor: SK Life Science, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00228969
• Collaborator: (none)
• Locations: 61
• Duration (Months): 14.9

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Refractory Epilepsy	Drug: RWJ-333369	Phase 2

Study Design

• Study Type: Interventional
• Primary Purpose: Treatment
• Study Start Date: Feb 1, 2005
• Actual Primary Completion Date: May 1, 2006
• Actual Study Completion Date: May 1, 2006

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 79 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Birmingham	Alabama	United States
2		Huntsville	Alabama	United States
3		Mobile	Alabama	United States
4		Northport	Alabama	United States
5		Phoenix	Arizona	United States
6		Little Rock	Arkansas	United States
7		Irvine	California	United States
8		Northridge	California	United States
9		Sacramento	California	United States
10		Fort Collins	Colorado	United States
11		Wilmington	Delaware	United States
12		Decatur	Georgia	United States
13		Lexington	Kentucky	United States
14		Louisville	Kentucky	United States
15		Baton Rouge	Louisiana	United States
16		Golden Valley	Minnesota	United States
17		St. Paul	Minnesota	United States
18		Chesterfield	Missouri	United States
19		Cincinnati	Ohio	United States
20		Portland	Oregon	United States
21		Philadelphia	Pennsylvania	United States
22		Sellersville	Pennsylvania	United States
23		Nashville	Tennessee	United States
24		Dallas	Texas	United States
25		El Paso	Texas	United States
26		Bennington	Vermont	United States
27		Charlottesville	Virginia	United States
28		Roanoke	Virginia	United States
29		Madison	Wisconsin	United States
30		Ciudad de Buenos Aires		Argentina
31		Ciudad de Cordoba		Argentina
32		Salta		Argentina
33		Budapest		Hungary
34		Debrecen		Hungary
35		Gyor		Hungary
36		Pecs		Hungary
37		Zalaegerszeg-Pozva		Hungary
38		Breda		Netherlands
39		Heemstede		Netherlands
40		Heeze		Netherlands
41		Rotterdam		Netherlands
42		Gdansk		Poland
43		Katowice		Poland
44		Kielce		Poland
45		Krakow		Poland
46		Lublin		Poland
47		Mosina		Poland
48		Warszawa		Poland
49		Zabrze		Poland
50		Moscow		Russian Federation
51		Saint-Petersburg		Russian Federation
52		Samara		Russian Federation
53		Barcelona		Spain
54		Madrid		Spain
55		Malaga		Spain
56		Pamplona		Spain
57		Glasgow		United Kingdom
58		Middlesbrough		United Kingdom
59		Northampton		United Kingdom
60		Oxford		United Kingdom
61		Reading		United Kingdom

Sponsors and Collaborators

• SK Life Science, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: SK Life Science, Inc.
• ClinicalTrials.gov Identifier: NCT00228969
• Other Study ID Numbers: 333369-EPY-2003
• First Posted: Sep 29, 2005
• Last Update Posted: Aug 2, 2012
• Last Verified: Aug 1, 2012

• Additional relevant MeSH terms: Epilepsy; Drug Resistant Epilepsy

Study Results

No Results Posted as of Aug 2, 2012