Safety and Efficacy of 333369 in the Treatment of Partial Epilepsy

August 1, 2012 updated by: SK Life Science, Inc.
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Ciudad de Buenos Aires, Argentina
      • Ciudad de Cordoba, Argentina
      • Salta, Argentina
  • Hungary
      • Budapest, Hungary
      • Debrecen, Hungary
      • Gyor, Hungary
      • Pecs, Hungary
      • Zalaegerszeg-Pozva, Hungary
  • Netherlands
      • Breda, Netherlands
      • Heemstede, Netherlands
      • Heeze, Netherlands
      • Rotterdam, Netherlands
  • Poland
      • Gdansk, Poland
      • Katowice, Poland
      • Kielce, Poland
      • Krakow, Poland
      • Lublin, Poland
      • Mosina, Poland
      • Warszawa, Poland
      • Zabrze, Poland
  • Russian Federation
      • Moscow, Russian Federation
      • Saint-Petersburg, Russian Federation
      • Samara, Russian Federation
  • Spain
      • Barcelona, Spain
      • Madrid, Spain
      • Malaga, Spain
      • Pamplona, Spain
  • United Kingdom
      • Glasgow, United Kingdom
      • Middlesbrough, United Kingdom
      • Northampton, United Kingdom
      • Oxford, United Kingdom
      • Reading, United Kingdom
  • United States
    • Alabama
      • Birmingham, Alabama, United States
      • Huntsville, Alabama, United States
      • Mobile, Alabama, United States
      • Northport, Alabama, United States
    • Arizona
      • Phoenix, Arizona, United States
    • Arkansas
      • Little Rock, Arkansas, United States
    • California
      • Irvine, California, United States
      • Northridge, California, United States
      • Sacramento, California, United States
    • Colorado
      • Fort Collins, Colorado, United States
    • Delaware
      • Wilmington, Delaware, United States
    • Georgia
      • Decatur, Georgia, United States
    • Kentucky
      • Lexington, Kentucky, United States
      • Louisville, Kentucky, United States
    • Louisiana
      • Baton Rouge, Louisiana, United States
    • Minnesota
      • Golden Valley, Minnesota, United States
      • St. Paul, Minnesota, United States
    • Missouri
      • Chesterfield, Missouri, United States
    • Ohio
      • Cincinnati, Ohio, United States
    • Oregon
      • Portland, Oregon, United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
      • Sellersville, Pennsylvania, United States
    • Tennessee
      • Nashville, Tennessee, United States
    • Texas
      • Dallas, Texas, United States
      • El Paso, Texas, United States
    • Vermont
      • Bennington, Vermont, United States
    • Virginia
      • Charlottesville, Virginia, United States
      • Roanoke, Virginia, United States
    • Wisconsin
      • Madison, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SK Life Science, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Primary Completion (Actual)

May 1, 2006

Study Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

June 30, 2005

First Submitted That Met QC Criteria

September 27, 2005

First Posted (Estimate)

September 29, 2005

Study Record Updates

Last Update Posted (Estimate)

August 2, 2012

Last Update Submitted That Met QC Criteria

August 1, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 333369-EPY-2003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Refractory Epilepsy

Clinical Trials on RWJ-333369

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Macedonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe