Safety and Efficacy of 333369 in the Treatment of Partial Epilepsy

Completed · Phase 2

Conditions studied: Refractory Epilepsy

In brief

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

Key facts

Study ID

NCT00228969

Run by

SK Life Science, Inc.

Starts

2005-02-01

Expected to finish

2006-05-01

Last updated by the study team

2012-08-02

Who can join

Age: 18 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Study site — Huntsville, Alabama, United States
• Study site — Mobile, Alabama, United States
• Study site — Northport, Alabama, United States
• Study site — Phoenix, Arizona, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Irvine, California, United States
• Study site — Northridge, California, United States
• Study site — Sacramento, California, United States
• Study site — Fort Collins, Colorado, United States
• Study site — Wilmington, Delaware, United States
• Study site — Decatur, Georgia, United States
• Study site — Lexington, Kentucky, United States
• Study site — Louisville, Kentucky, United States
• Study site — Baton Rouge, Louisiana, United States
• Study site — Golden Valley, Minnesota, United States
• Study site — Saint Paul, Minnesota, United States
• Study site — Chesterfield, Missouri, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Portland, Oregon, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Sellersville, Pennsylvania, United States
• Study site — Nashville, Tennessee, United States
• Study site — Dallas, Texas, United States
• Study site — El Paso, Texas, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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