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

• Sponsor: SK Life Science, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00697918
• Collaborator: (none)
• Enrollment: 11
• Arm: 1
• Duration (Months): 13

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Seizures	Drug: RWJ-333369	Phase 3

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 Design

• Study Type: Interventional
• Actual Enrollment: 11 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: Mar 1, 2008
• Actual Primary Completion Date: Apr 1, 2009
• Actual Study Completion Date: Apr 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 001 RWJ-333369100 mg to 400 mg twice daily	Drug: RWJ-333369; 100 mg to 400 mg twice daily

Outcome Measures

Primary Outcome Measures

1. 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

1. Percent reduction in partial seizure frequency [For 1 year.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• SK Life Science, Inc.

Investigators

• Study Director: Janssen Pharmaceutical K.K. Clinical Trial, Janssen Pharmaceutical K.K.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: SK Life Science, Inc.
• ClinicalTrials.gov Identifier: NCT00697918
• Other Study ID Numbers: CR014287; 333369-KJ-03
• First Posted: Jun 16, 2008
• Last Update Posted: Jan 16, 2013
• Last Verified: Jan 1, 2013

• Keywords provided by SK Life Science, Inc.: Partial onset seizure; Adjunctive therapy
• Additional relevant MeSH terms: Seizures

Study Results

No Results Posted as of Jan 16, 2013