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Completed

NCT Number: NCT00228969

Safety and Efficacy of 333369 in the Treatment of Partial Epilepsy

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

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Key information

Conditions

Refractory Epilepsy Brain Diseases Central Nervous System Diseases Drug Resistant Epilepsy Epilepsy Nervous System Diseases

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ciudad de Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

RWJ-333369

Drug

Sponsors and collaborators

Lead sponsor

SK Life Science, Inc.

Industry

Registry information

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Sep 29, 2005
Registry last updated
Aug 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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