Brivaracetam in focal epilepsy – Efficacy,Safety,Tolerability(BRIVEST)
Research type
Research Study
Full title
Brivaracetam in focal-onset epilepsy: Efficacy, Safety and Tolerability (BRIVEST) – A study of ‘real-life’ clinical experience in a regional tertiary epilepsy centre \n\n
IRAS ID
248225
Contact name
Katarzyna Sieradzan
Contact email
Sponsor organisation
North Bristol NHS Trust
Duration of Study in the UK
1 years, 7 months, 5 days
Research summary
Brivaracetam is a new antiepileptic drug (AED), which has been licensed in the UK since 2016. The current knowledge about the efficacy, safety and tollerability of Brivaracetam is primarily derived from Randomised Controlled Trials (RCTs) and long-term open label follow up of patients who participated in Phase IIb and Phase III clinical trials. However, in such trials, inclusion and exclusion criteria are narrow and stringent. Many patients with drug-resistant epilepsy do not fulfil these criteria, or are unable to participate for logistical reasons, and are therefore missed or not well represented in RCTs. Therefore, to date, there is limited evidence of the practical value of Brivaracetam in the ‘real-world’ and there is a clear need to explore and understand the clinical use of Brivaracetam in a wider, more diverse population of epilepsy patients. This single centre study at North Bristol NHS Trust, will employ an observational approach, to capture ‘real-world’ data on the effects of treatment with Brivaracetam over a longer post-licensing period. This will provide additional information on how well this newly introduced antiepileptic drug performs in everyday clinical practice. The study aims to recruit an estimated 120 patients who have started taking Brivaracetam for the treatment of their epilepsy, as part of their normal clinical care. Data will be collected during interviews with the patients, on seizure frequency, side effects experienced, adverse events/reactions, quality of life, and psychological wellbeing. The study will be as inclusive as is ethically and safely possible, in order to capture ‘real-world’ data from a diverse and representative cohort of patients. Such ‘real-world’ data adds to the experience derived from RCTs, is crucial for deeper understanding of the therapeutic potential and safety profile of this new drug and could contribute towards optimising its use in various clinical scenarios.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
18/YH/0292
Date of REC Opinion
27 Sep 2018
REC opinion
Further Information Favourable Opinion