Status:

COMPLETED

Long Term Effectiveness and Safety Study for RWJ-333369 as Adjunctive Therapy in Korean and Japanese Patients With Partial Onset Seizures

Lead Sponsor:

SK Life Science, Inc.

Conditions:

Seizures

Eligibility:

All Genders

16+ years

Phase:

PHASE3

Brief Summary

The purpose of this study is to evaluate the long-term safety of RWJ-333369 at doses between 200-800 mg/day in Korean and Japanese patients who have completed the preceding study (333369-KJ-02).

Detailed Description

Despite the introduction of new antiepileptic drugs into overseas clinical settings after 1990's, there still exist those patients who cannot control seizures, and thus the advent of newer antiepilept...

Eligibility Criteria

Inclusion

  • Patients in the preceding study (333369-KJ-02) who have completed Double-Blind Treatment Phase of preceding study

Exclusion

  • Considered ineligible as study patients by the investigator

Key Trial Info

Start Date :

March 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 1 2009

Estimated Enrollment :

11 Patients enrolled

Trial Details

Trial ID

NCT00697918

Start Date

March 1 2008

End Date

April 1 2009

Last Update

January 16 2013

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