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Brivaracetam Safety and Efficacy Follow-up Study in Subjects With Epilepsy | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

An Open-label, Multicenter, Follow-up Study to Evaluate the Long-term Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment in Subjects Aged 16 Years or Older With Epilepsy

NCT01339559•UCB BIOSCIENCES, Inc.

View on ClinicalTrials.gov

Summary

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

Detailed Description

The primary objective is to evaluate the long term safety and tolerability of BRV at individualized doses up to a maximum of 200 mg/day in epilepsy subjects.

Eligibility

Age

16 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subject completed the Treatment Period of N01358 or the evaluation period of N01258
•Male/female subject from 16 years or older. Subject under 18 years may only be included where legally permitted and ethically accepted
•Subject for whom the Investigator believes a reasonable benefit from the long term administration of BRV may be expected
•Female subject without childbearing potential (premenarcheal, postmenopausal for at least 2 years, bilateral oophorectomy or tubal ligation, complete hysterectomy) are eligible

Exclusion Criteria

•Subject has developed hypersensitivity to any components of the investigational medicinal product (IMP) or comparative drugs as stated in this protocol during the course of the core studies
•Severe medical, neurological, or psychiatric disorders, or laboratory values which may have an impact on the safety of the subject
•Poor compliance with the visit schedule or medication intake in the previous BRV study
•Planned participation in any other clinical study of another investigational drug or device during this study
•Pregnant or lactating woman
•Any medical condition which, in the Investigator's opinion, warrants exclusion
•Subject has a lifetime history of suicide attempt or has suicidal ideation in the past 6 months

Locations (184)

001

Phoenix, Arizona, United States

013

Phoenix, Arizona, United States

006

Tucson, Arizona, United States

775

Little Rock, Arkansas, United States

025

San Francisco, California, United States

060

Aurora, Colorado, United States

071

Miami, Florida, United States

027

Orlando, Florida, United States

064

Port Charlotte, Florida, United States

023

Atlanta, Georgia, United States

Key Dates

Start Date

May 11, 2011

Primary Completion Date

April 18, 2019

Completion Date

April 18, 2019

Last Updated

August 17, 2021

Enrollment

767

ACTUAL participants

Conditions

Epilepsy

Interventions

Brivaracetam

DRUG

Thalamus Seizure Detection With a Deep Brain Stimulator System

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Epilepsy; Seizure

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RECRUITINGPHASE1

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Epilepsy

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 17, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Thalamus Seizure Detection With a Deep Brain Stimulator System

Investigation of Blood-Brain-Barrier Breakdown Using Manganese Magnetic Resonance Imaging in Drug-Resistant Epilepsy

Intracranial Investigation of Neural Circuity Underlying Human Mood

Late-Onset Seizures: Trial of Vascular Risk Investigation and Treatment

AI-Based Mobile Intervention on Medication Non-Adherence and Transition

MEHMO Natural History and Biomarkers