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Evaluation of Long-term Safety, and Efficacy of Brivaracetam (BRV) Used as Adjunctive Treatment in Subjects With Epilepsy | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Evaluation of Long-term Safety, and Efficacy of Brivaracetam (BRV) Used as Adjunctive Treatment 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 Phase 3b

NCT01728077•UCB Pharma SA

View on ClinicalTrials.gov

Summary

N01372 study is to evaluate the long-term safety, tolerability, maintenance of efficacy of Brivaracetam (BRV); as well as the effect of BRV on subjects' health-related quality of life and to explore the direct medical resource use for BRV (for subjects entering N01372 from a study where pharmacoeconomic data was collected). BRV will be used at doses up to maximum of 200 mg/day, as adjunctive treatment in subjects aged 16 years or older with Epilepsy.

Detailed Description

Flexible dosing up to 200 mg/day, twice daily (10, 25 and 50 mg oral film-coated tablets). The study will continue until either regulatory approval of BRV has been granted by any Health Authority in an indication of adjunctive treatment of Epilepsy, or until the Sponsor decides to close the study, or until the BRV development is stopped by the Sponsor.

Eligibility

Age

16 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subject is male or female and 16 years or older. Subjects under 18 years of age may be included only where legally permitted and ethically accepted
•Subjects having completed the Treatment Period of an applicable previous BRV study, and have access to the present study
•Subject for whom the investigator believes a reasonable benefit from the long-term administration of BRV may be expected
•Subjects must be able to take the oral film-coated tablets of BRV

Exclusion Criteria

•Subject has developed hypersensitivity to any components of the Investigational Medicinal Product (IMP) or comparative drugs as stated in the protocol during the course of the prior study
•Severe medical, neurological, or psychiatric disorders, or laboratory values that 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 (including an actual attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response ("Yes") to either question 4 or question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at the last visit of the previous study or at the Entry Visit of this study if not completed at the last visit of the previous study

Locations (10)

103

Little Rock, Arkansas, United States

108

Lexington, Kentucky, United States

109

New York, New York, United States

106

Akron, Ohio, United States

110

Dallas, Texas, United States

102

Salt Lake City, Utah, United States

201

Paris, France

303

Bernau, Germany

300

Kehl-Kork, Germany

502

Seville, Spain

Key Dates

Start Date

October 1, 2012

Primary Completion Date

August 1, 2016

Completion Date

August 1, 2016

Last Updated

July 11, 2018

Enrollment

ACTUAL participants

Conditions

Epilepsy

Interventions

Brivaracetam

DRUG

Thalamus Seizure Detection With a Deep Brain Stimulator System

NCT06700356

Epilepsy; Seizure

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RECRUITINGPHASE1

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

NCT02531880

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: July 11, 2018Data 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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Evaluation of Long-term Safety, and Efficacy of Brivaracetam (BRV) Used as Adjunctive Treatment 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

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