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A Double-blind, Randomized Conversion to Monotherapy Study to Evaluate the Efficacy and Safety of Brivaracetam in Subjects (≥ 16 to 75 Years Old) With Partial Onset Seizures

NCT00698581 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2018-07-11

Study results available
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Summary

Antiepileptic drugs (AEDs) are the main treatment for epilepsy; however, only a limited number of AEDs are approved for use as monotherapy. The objective of this study is to evaluate the efficacy of Brivaracetam (BRV) in the conversion of partial onset seizure patients from combination treatment to monotherapy

Conditions

Interventions

DRUG

Brivaracetam

25 mg tablet - 50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg \> 20 mg) for subjects not participating in the follow-up study)

DRUG

Brivaracetam

25 mg tablet - 100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg \> 50 mg \> 20 mg) for subjects not participating in the follow-up study)

Sponsors & Collaborators

  • UCB Pharma

    lead INDUSTRY

Principal Investigators

  • UCB Clinical Trial Call Center · +1 877 822 9493 (UCB)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2010-01-31
Completion
2010-02-28

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Czechia
  • Germany
  • Sweden

Study Locations

More Related Trials

Entities

Diseases

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 NCT00698581 on ClinicalTrials.gov