A Phase 3 interventional study of RWJ-333369 in Seizures, sponsored by SK Life Science, Inc.. Completed. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2013-01-16.
Sponsored by SK Life Science, Inc. · Phase 3, Interventional, and Treatment
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).
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.
881 studies on the registry are indexed under Seizures; 143 are open to participants now.
This study's enrollment of 11 is below the median of 64 across 610 interventional studies indexed under Seizures.
Browse Seizures studies →SK Life Science, Inc. is the lead sponsor of 41 studies on the registry; 2 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 1 (8%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
RWJ-333369100 mg to 400 mg twice daily
Drug: RWJ-333369
100 mg to 400 mg twice daily
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.
Percent reduction in partial seizure frequency
Time frame: For 1 year.
No study locations are listed for this record.
This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
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SK Life Science, Inc.