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

Phase 3

Completed

• Conditions: Seizures
• Interventions: Drug: RWJ-333369

• Registration Number: NCT00697918
• Lead Sponsor: SK Life Science, Inc.

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 antiepileptic drugs is being desired. This is a multicenter, open-label, extension study in patients who have completed the preceding study (333369-KJ-02) and scheduled to continue until the study drug is approved. This study consists of Period 1 (1 year) and Period 2 (only in Japan; planned to continue until the drug is approved Primary objective of this study is to evaluate the long-term safety (Adverse event, Lab test, Electrocardiogram, Vital signs, Pregnancy test, Physician Withdrawal Checklist) of RWJ-333369 at doses between 200-800 mg/day in patients who have completed the preceding study. Secondary objective of this study is to evaluate the long-term effectiveness of RWJ-333369 at doses between 200-800 mg/day in patients who have completed the preceding study. Period 1:RWJ-333369 will be started at 400 mg/day. RWJ-333369 100 mg tablets or 200 mg tablets will be orally administered with noncarbonated water twice daily. The dose will be adjusted between 200 mg/day and 800 mg/day based on effectiveness and tolerance. Period 2: The dose will be adjusted between 200 mg/day and 800 mg/day based on effectiveness and tolerance.

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-06-12
• Study First Submitted QC: 2008-06-12
• Study First Posted: 2008-06-16
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Status Verified: 2013-01
• Disposition First Submitted: 2013-01-15
• Disposition First Submitted QC: 2013-01-15
• Last Update Submitted: 2013-01-15
• Disposition First Posted: 2013-01-16
• Last Update Posted: 2013-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

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

Exclusion Criteria

• Considered ineligible as study patients by the investigator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
001	RWJ-333369	RWJ-333369100 mg to 400 mg twice daily

Primary Outcome Measures

Name	Time	Method
Adverse events (subjective/objective findings), blood pressure, pulse rate, body temperature, weight, 12-lead ECG, laboratory tests, pregnancy test. Time measure is 1 year.	For 1 year.

Secondary Outcome Measures

Name	Time	Method
Percent reduction in partial seizure frequency	For 1 year.