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

NCT ID: NCT00697762

Last Updated: 2013-01-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2008-05-31

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

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, placebo-controlled, double-blind (neither the study physician nor the patient knows the name of the study assigned medication), randomized (study drug assigned by chance), parallel-group study. It consists of three periods: Pretreatment Phase (screening and baseline periods), Double-Blind Treatment Phase, and Posttreatment Phase (transitional period or dose-tapering/withdrawal period). Patients who complete Double-Blind Treatment Phase will be qualified to participate in the long-term extension study (Study 333369-KJ-03) following the present study. The primary hypothesis is that at 400mg/day of RWJ-333369 is effective in the adjunctive treatment of patients with partial onset epilepsy, as measured by the percent reduction from baseline in monthly seizure frequency of partial onset seizures. Safety is evaluated based on the following variables; Adverse event, Lab test, Electrocardiogram, Vital signs, Pregnancy test, Physician Withdrawal Checklist. Patients will receive the assigned dose (placebo, 200 mg/day, or 400 mg/day) twice daily orally for 12 weeks (85 days)

Conditions

Seizures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

003

Placebo tablet twice daily for 12 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo tablet twice daily for 12 weeks

002

RWJ-333369 200 mg tablet twice daily for 12 weeks

Group Type: EXPERIMENTAL

RWJ-333369

Intervention Type: DRUG

200 mg tablet twice daily for 12 weeks

001

RWJ-333369 100 mg tablet twice daily for 12 weeks

Group Type: EXPERIMENTAL

RWJ-333369

Intervention Type: DRUG

100 mg tablet twice daily for 12 weeks

Interventions

RWJ-333369

200 mg tablet twice daily for 12 weeks

Intervention Type: DRUG

RWJ-333369

100 mg tablet twice daily for 12 weeks

Intervention Type: DRUG

Placebo

Placebo tablet twice daily for 12 weeks

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SK Life Science, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Pharmaceutical K.K. Clinical Trial

Role: STUDY_DIRECTOR

Janssen Pharmaceutical K.K.

Other Identifiers

333369-KJ-02

Identifier Type: -

Identifier Source: secondary_id

CR014284

Identifier Type: -

Identifier Source: org_study_id