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A Study to Evaluate the Efficacy and Safety of Brivaracetam in Study Participants (>=16 to 80 Years of Age) With Epilepsy

NCT03083665 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 449

Last updated 2025-10-14

Study results available
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Summary

The purpose of the study is to evaluate the efficacy of brivaracetam (BRV) compared to placebo (PBO) as adjunctive treatment in subjects (\>=16 to 80 years of age) with partial seizures with or without secondary generalization despite current treatment with 1 or 2 concomitant antiepileptic drugs (AEDs) and to assess the safety and tolerability of BRV in subjects \>= 16 years to 80 years of age.

Conditions

  • Partial Seizures With or Without Secondary Generalization
  • Epilepsy

Interventions

DRUG

Placebo

* Pharmaceutical form: Film-coated tablets * Route of administration: Oral use

DRUG

Brivaracetam

* Pharmaceutical form: Film-coated tablets * Concentration: 25 mg tablets and 50 mg tablets * Route of administration: Oral use

Sponsors & Collaborators

  • UCB Biopharma SRL

    lead INDUSTRY

Principal Investigators

  • UCB Cares · 001 844 599 2273 (UCB)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-08-22
Primary Completion
2022-06-30
Completion
2022-06-30

Countries

  • China
  • Japan
  • Malaysia
  • Philippines
  • Singapore
  • Taiwan
  • Thailand

Study Locations

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Entities

Drugs
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 NCT03083665 on ClinicalTrials.gov