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

NCT00697762 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2013-01-23

No results posted yet for this study

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).

Conditions

Interventions

DRUG

RWJ-333369

200 mg tablet twice daily for 12 weeks

DRUG

RWJ-333369

100 mg tablet twice daily for 12 weeks

DRUG

Placebo

Placebo tablet twice daily for 12 weeks

Sponsors & Collaborators

  • SK Life Science, Inc.

    lead INDUSTRY

Principal Investigators

  • Janssen Pharmaceutical K.K. Clinical Trial · Janssen Pharmaceutical K.K.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2008-05-31
Completion
2008-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00697762 on ClinicalTrials.gov