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A Study of the Effectiveness, Safety, and Tolerability of Carisbamate as Add-On Therapy in Patients With Partial Onset Seizures.

NCT00740623 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 547

Last updated 2013-01-24

No results posted yet for this study

Summary

The purpose of this study is to evaluate the effectiveness, safety, and tolerability of carisbamate as add-on therapy for the treatment of partial onset seizures in patients with epilepsy.

Conditions

  • Epilepsy, Partial, Motor
  • Epilepsy, Complex Partial
  • Epilepsy, Simple Partial
  • Focal Motor Epilepsy

Interventions

DRUG

Carisbamate

800 mg/day for 14 weeks

DRUG

placebo

placebo for 14 weeks

DRUG

Carisbamate

1,200 mg/day for 14 weeks

Sponsors & Collaborators

  • SK Life Science, Inc.

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2009-10-31
Completion
2010-04-30

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Drugs

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 NCT00740623 on ClinicalTrials.gov