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

This study has been terminated.
(The trial was stopped based on information from the global phase 3 studies.)
Sponsor:
Information provided by (Responsible Party):
SK Life Science
ClinicalTrials.gov Identifier:
NCT00697762
First received: June 12, 2008
Last updated: January 14, 2013
Last verified: January 2013
  Purpose

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).


Condition Intervention Phase
Seizures
Drug: RWJ-333369
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind Study to Evaluate the Effectiveness and Safety of RWJ-333369 as Adjunctive Therapy in Korean and Japanese Patients With Partial Onset Seizures

Resource links provided by NLM:


Further study details as provided by SK Life Science:

Primary Outcome Measures:
  • Percent reduction in partial seizure frequency (including simple partial motor seizures, complex partial seizures, and secondarily generalized seizures) for Double-Blind Treatment Phase from the baseline period [ Time Frame: From begining to end of Double-Blind Treatment Phase (for 12 weeks). ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 50% responder rate: The proportion of patients with a 50% reduction or more in the number of partial seizures for Double-Blind Treatment Phase from Pretreatment Phase (baseline period) [ Time Frame: From begining to end of Double-Blind Treatment Phase (for 12 weeks). ] [ Designated as safety issue: No ]

Enrollment: 56
Study Start Date: October 2007
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 003
Placebo tablet twice daily for 12 weeks
Drug: Placebo
Placebo tablet twice daily for 12 weeks
Experimental: 002
RWJ-333369 200 mg tablet twice daily for 12 weeks
Drug: RWJ-333369
200 mg tablet twice daily for 12 weeks
Experimental: 001
RWJ-333369 100 mg tablet twice daily for 12 weeks
Drug: RWJ-333369
100 mg tablet twice daily for 12 weeks

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)

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00697762

Sponsors and Collaborators
SK Life Science
Investigators
Study Director: Janssen Pharmaceutical K.K. Clinical Trial Janssen Pharmaceutical K.K.
  More Information

No publications provided

Responsible Party: SK Life Science
ClinicalTrials.gov Identifier: NCT00697762     History of Changes
Other Study ID Numbers: CR014284, 333369-KJ-02
Study First Received: June 12, 2008
Last Updated: January 14, 2013
Health Authority: Japan: Japan Pharmaceuticals And Medical Devices Evaluation Center

Keywords provided by SK Life Science:
Partial onset seizure
Adjunctive therapy

Additional relevant MeSH terms:
Seizures
Brain Diseases
Central Nervous System Diseases
Epilepsy
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on October 29, 2014