NCT00697918

Brief Summary

The purpose of this study is to evaluate the long-term safety of RWJ-333369 at doses between 200-800 mg/day in Korean and Japanese patients who have completed the preceding study (333369-KJ-02).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2008

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 16, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

January 16, 2013

Status Verified

January 1, 2013

Enrollment Period

1.1 years

First QC Date

June 12, 2008

Last Update Submit

January 15, 2013

Conditions

Seizures

Keywords

Partial onset seizureAdjunctive therapy

Outcome Measures

Primary Outcomes (1)

  • Adverse events (subjective/objective findings), blood pressure, pulse rate, body temperature, weight, 12-lead ECG, laboratory tests, pregnancy test. Time measure is 1 year.

    For 1 year.

Secondary Outcomes (1)

  • Percent reduction in partial seizure frequency

    For 1 year.

Study Arms (1)

001

EXPERIMENTAL

RWJ-333369100 mg to 400 mg twice daily

Drug: RWJ-333369

Interventions

RWJ-333369DRUG

100 mg to 400 mg twice daily

001

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients in the preceding study (333369-KJ-02) who have completed Double-Blind Treatment Phase of preceding study

You may not qualify if:

  • Considered ineligible as study patients by the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Seizures

Interventions

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

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological 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
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2008

First Posted

June 16, 2008

Study Start

March 1, 2008

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

January 16, 2013

Record last verified: 2013-01