NCT00210652

Brief Summary

The purpose of this study is to evaluate the safety and preliminary effectiveness of the novel compound RWJ-333369 in patients with partial onset seizures who are currently being treated with 1 or 2 concomitant antiepileptic drugs.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2004

Longer than P75 for phase_2

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

January 24, 2013

Status Verified

January 1, 2013

Enrollment Period

5.7 years

First QC Date

September 13, 2005

Last Update Submit

January 15, 2013

Conditions

EpilepsyEpilepsies, Partial

Keywords

EpilepsyRefractory partial epilepsyseizure disorderantiepileptic drugs

Outcome Measures

Primary Outcomes (1)

  • Adverse events as a measure of safety and tolerability

    At followup visits every 3 months up to the time RWJ-333369 is available by prescription or study is terminated by sponsor

Secondary Outcomes (1)

  • Seizure counts

    Up to 3 months

Study Arms (1)

001

EXPERIMENTAL

RWJ 333369: Open-Label Extension: One 250mg tablet twice daily up to a total of 1200mg/day up until RWJ-33369 is available by prescription or study is terminated by sponsor

Drug: RWJ 333369:

Interventions

RWJ 333369:DRUG

Open-Label Extension: One 250mg tablet twice daily up to a total of 1200mg/day up until RWJ-33369 is available by prescription or study is terminated by sponsor

001

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • In order to enter the open label extension, the patient must have completed Study 333369EPY-2001.

You may not qualify if:

  • Patients who have seizures that cannot be quantitated accurately
  • patients with a history of nonepileptic seizures, serious systemic disease, progressive neurologic disorder, a major psychiatric disorder, status epilepticus in the past 3 months, vagal nerve stimulation discontinuation within the past 3 months
  • patients with a history of drug or alcohol abuse within the past 2 years
  • patients currently taking felbamate, vigabatrin, or tricyclic antidepressants
  • and female patients who are pregnant or nursing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

EpilepsyEpilepsies, Partial

Interventions

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

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

July 1, 2004

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

January 24, 2013

Record last verified: 2013-01