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

NCT00697762 | Terminated Phase 3

• 2 other identifiers: CR014284333369-KJ-02
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Seizures

Keywords

Partial onset seizure; Adjunctive therapy

Outcome Measures

Primary Outcomes (1)

• 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

  From begining to end of Double-Blind Treatment Phase (for 12 weeks).

Secondary Outcomes (1)

• 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)

  From begining to end of Double-Blind Treatment Phase (for 12 weeks).

Study Arms (3)

003

PLACEBO COMPARATOR

Placebo tablet twice daily for 12 weeks

Drug: Placebo

002

EXPERIMENTAL

RWJ-333369 200 mg tablet twice daily for 12 weeks

Drug: RWJ-333369

001

EXPERIMENTAL

RWJ-333369 100 mg tablet twice daily for 12 weeks

Drug: RWJ-333369

Interventions

RWJ-333369 DRUG

200 mg tablet twice daily for 12 weeks

002

Placebo DRUG

Placebo tablet twice daily for 12 weeks

003

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• SK Life Science, Inc.: lead

MeSH Terms

Conditions

Seizures

Interventions

S-2-O-carbamoyl-1-o-chlorophenyl-ethanol

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Janssen Pharmaceutical K.K. Clinical Trial

  Janssen Pharmaceutical K.K.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2008
• First Posted: June 16, 2008
• Study Start: October 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: January 23, 2013

Record last verified: 2013-01