NCT03517423

Brivaracetam: a Prospective and Multicentre Post-marketing Observational Study

Completed Last updated 19 December 2023

What this trial tests

trial testing Brivaracetam in Epilepsy in 51 participants. Completed in 29 August 2023.

Timeline

4 October 2018

Primary endpoint
1 December 2022

29 August 2023

Quick facts

Lead sponsor	Centre hospitalier de l'Université de Montréal (CHUM)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	51
Start date	4 October 2018
Primary completion	1 December 2022
Estimated completion	29 August 2023
Sites	1 location across Canada

Drugs / interventions tested

• Brivaracetam (BRIVARACETAM) — full drug profile →

Conditions studied

• Epilepsy — all drugs for Epilepsy →

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Who can join

18 and older, any sex, with Epilepsy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Brivaracetam (BRV) is a new antiepileptic drug approved in March 2016 by Health Canada for the adjunctive treatment of focal epilepsy in adults. While randomized controlled trials represent the gold standard in measuring intervention efficacy, the generalizability of these findings to usual clinical practice remains uncertain.

The primary objective of this study is to evaluate the effectiveness of BRV as an adjunctive treatment in epilepsy. The secondary objective of this study is to evaluate the tolerability of BRV as an adjunctive treatment in epilepsy.

This is a prospective and multicentre post-marketing observational study. All consecutive adult patients (i.e. aged at least 18 years) in whom BRV is introduced in participating medical centres, ambulatory or hospitalized, will be approached to participate in the study. The investigators will exclude individuals with generalized epilepsy as those aged less than 18 years, in order to respect current Health Canada indications. The investigators will exclude individuals cognitively or physically unable to complete the study questionnaires.

The investigators will collect data from participants during three clinical visits with their regular treating physician. These will be the baseline visit, the 3-month visit (three months following the initiation of BRV), and the 6-month visit. At each visit, the investigators will collect data on seizure type(s) and frequency. Study participants will also complete four questionnaires to measure irritability, anxiety, depression, and quality of life.

There will be two primary study outcomes. These are: a) mean percent change in monthly seizure frequency; and b) proportion with at least a 50% decrease in seizure frequency. There will be several secondary study endpoints: a) mean change in irritability \[measured using the Brief Irritability Test (BITe)\]; b) mean change in generalised anxiety \[measured using the Generalized Anxiety Disorder - 7 (GAD-7) scale\]; c) mean change in depression \[measured using the Neurological Disorders Depression Inventory (NDDI-E) scale\]; d) mean change in quality of life \[measured using the 7-item Quality of Life Inventory in Epilepsy-10 (QOLIE-10) scale\]; e) the proportion of individuals that are seizure free, and f) change in distribution of seizure types (e.g. focal with motor seizures, generalized absence). The investigators will query for all adverse effects the participant may experience.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.