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Double-blind, Randomized Study Evaluating the Efficacy and Safety of Brivaracetam in Adults With Partial Onset Seizures

NCT00464269 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2022-07-21

Study results available
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Summary

This study will evaluate the efficacy and safety of Brivaracetam to support the submission file in the indication of adjunctive treatment in adolescents and adults with partial onset seizures.

Conditions

Interventions

OTHER

Placebo

* Active Substance: Placebo * Pharmaceutical Form: Film-coated tablet * Concentration: 2.5 mg, 10 mg and 25 mg * Route of Administration: Oral use

DRUG

Brivaracetam 2.5 mg

* Active Substance: Brivaracetam * Pharmaceutical Form: Film-coated tablet * Concentration: 2.5 mg * Route of Administration: Oral use

DRUG

Brivaracetam 10 mg

* Active Substance: Brivaracetam * Pharmaceutical Form: Film-coated tablet * Concentration: 10 mg * Route of Administration: Oral use

DRUG

Brivaracetam 25 mg

* Active Substance: Brivaracetam * Pharmaceutical Form: Film-coated tablet * Concentration: 25 mg * Route of Administration: Oral use

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
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2008-12-31
Completion
2009-01-31

Countries

  • United States
  • Australia
  • Brazil
  • Canada
  • Mexico

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 NCT00464269 on ClinicalTrials.gov