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

Seizures Clinical Trial

Official title:

An Extension Study to Evaluate the Safety and Effectiveness of RWJ-333369 as Adjunctive Therapy in Korean and Japanese Patients With Partial Onset Seizures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00697918
• Other study ID #: CR014287
• Secondary ID: 333369-KJ-03
• Status: Completed
• Phase: Phase 3
• First received: June 12, 2008
• Last updated: January 15, 2013
• Start date: March 2008
• Est. completion date: April 2009

Study information

• Verified date: January 2013
• Source: SK Life Science
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Japan Pharmaceuticals And Medical Devices Evaluation Center
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Seizures

Intervention

Drug:
• RWJ-333369
100 mg to 400 mg twice daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
SK Life Science

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Secondary	Percent reduction in partial seizure frequency		For 1 year.	No