Long Term Effectiveness and Safety Study for RWJ-333369 as Adjunctive Therapy in Korean and Japanese Patients With Partial Onset Seizures
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Seizures |
Drug: RWJ-333369 |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
- Adverse events (subjective/objective findings), blood pressure, pulse rate, body temperature, weight, 12-lead ECG, laboratory tests, pregnancy test. Time measure is 1 year. [ Time Frame: For 1 year. ] [ Designated as safety issue: Yes ]
- Percent reduction in partial seizure frequency [ Time Frame: For 1 year. ] [ Designated as safety issue: No ]
| Enrollment: | 11 |
| Study Start Date: | March 2008 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 001
RWJ-333369100 mg to 400 mg twice daily
|
Drug: RWJ-333369
100 mg to 400 mg twice daily
|
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.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| 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
More Information
No publications provided
| Responsible Party: | SK Life Science |
| ClinicalTrials.gov Identifier: | NCT00697918 History of Changes |
| Other Study ID Numbers: | CR014287, 333369-KJ-03 |
| Study First Received: | June 12, 2008 |
| Last Updated: | January 15, 2013 |
| Health Authority: | Japan: Japan Pharmaceuticals And Medical Devices Evaluation Center |
Keywords provided by SK Life Science:
|
Partial onset seizure Adjunctive therapy |
Additional relevant MeSH terms:
|
Seizures Epilepsy Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Neurologic Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 22, 2013