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Brivaracetam Safety and Efficacy Follow-up Study in Subjects With Epilepsy

NCT01339559 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 767

Last updated 2021-08-17

Study results available
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Summary

This is a Phase 3, open label, long term follow-up (LTFU), multicenter, noncomparative, and single arm study of brivaracetam (BRV).

Conditions

Interventions

DRUG

Brivaracetam

Tablet, Flexible dosing up to 200 mg/day, twice daily. The study will continue until either regulatory approval of brivaracetam has been granted by any Health Authority in an indication of adjunctive treatment of partial onset seizures or until the Sponsor decides to close the study, or until the investigational product development is stopped by the Sponsor.

Sponsors & Collaborators

  • UCB BIOSCIENCES, Inc.

    lead INDUSTRY

Principal Investigators

  • UCB Cares · +1 844 599 2273 (UCB)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-11
Primary Completion
2019-04-18
Completion
2019-04-18

Countries

  • United States
  • Austria
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • Czechia
  • Estonia
  • Finland
  • France
  • Germany
  • Hong Kong
  • Hungary
  • India
  • Italy
  • Japan
  • Latvia
  • Lithuania
  • Mexico
  • Netherlands
  • Poland
  • Puerto Rico
  • Russia
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • United Kingdom

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 NCT01339559 on ClinicalTrials.gov