Status:
TERMINATED
Effectiveness and Safety Study for RWJ-333369 as Adjunctive Therapy in Korean and Japanese Patients With Partial Onset Seizures
Lead Sponsor:
SK Life Science, Inc.
Conditions:
Seizures
Eligibility:
All Genders
16+ years
Phase:
PHASE3
Brief Summary
The purpose of the study is to evaluate the effectiveness and safety of adjunctive RWJ-333369 at a dose of 200 or 400 mg/day in comparison with placebo in Korean and Japanese partial epilepsy patients...
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 antiepilept...
Eligibility Criteria
Inclusion
- Body weight of 40 kg or more
- Established diagnosis of partial epilepsy for at least 1 year
- Current treatment with at least one and no more than two antiepileptics (AEDs)
- At least 6 episodes of simple partial motor seizures, complex partial seizures, or secondarily generalized seizures for 2 months (56 days) during the baseline period (No seizure free interval for more than 3 weeks)
Exclusion
- Diagnosis of status epilepticus or epilepsia partialis continua within 6 months
- Patients with generalized epileptic syndrome
- Current or previous history of non-epileptic seizures, including psychogenic seizures
- Current or previous history of any serious or medically relevant systemic disease, including clinically apparent hepatic disease, renal failure, malignant neoplasm, insulin-requiring diabetes mellitus, or any disorder
- Patients with clinical evidence of significant cardiac disease
- Current or past (within 1 year) major significant psychotic disorder
- Have an ALT (GPT) greater than 1.5 times the upper reference limit or total bilirubin above the upper reference limit at screening laboratory tests
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00697762
Start Date
October 1 2007
End Date
May 1 2008
Last Update
January 23 2013
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