Brivaracetam Safety and Efficacy Follow-up Study in Subjects With Epilepsy (BRITE™)

UCB

Status and phase

Completed

Phase 3

Conditions

Epilepsy

Treatments

Drug: Brivaracetam

Study type

Interventional

Funder types

Industry

Identifiers

NCT01339559

N01379

2010-020345-27 (EudraCT Number)

Details and patient eligibility

About

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

Full 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.

Enrollment

767 patients

Sex

All

Ages

16+ years old

Volunteers

No 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