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

• Status: Terminated
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: All

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 who have poor seizure control with one or two antiepileptics (AEDs).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SK Life Science; SK Life Science, Inc.

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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