Safety and Efficacy of 333369 in the Treatment of Partial Epilepsy

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00228969

Enrollment

Unknown

Registered

2005-09-29

Start date

2005-02-28

Completion date

2006-05-31

Last updated

2012-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractory Epilepsy

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

Interventions

DRUGRWJ-333369

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

18 Years to 79 Years

Healthy volunteers

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.

Countries

Argentina, Hungary, Netherlands, Poland, Russia, Spain, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026