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Brivaracetam: a Prospective and Multicentre Post-marketing Observational Study

NCT03517423 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 51

Last updated 2023-12-19

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Brivaracetam

An antiepileptic drug whose putative mechanism of action is as a result of direct inhibition of SV2A receptors, responsible for the successful release of excitatory neurotransmitters from the the neuronal presynaptic membrane.

Sponsors & Collaborators

  • UCB Pharma

    collaborator INDUSTRY

  • Centre hospitalier de l'Université de Montréal (CHUM)

    lead OTHER

Principal Investigators

  • Mark R Keezer, MDCM PhD · CHUM

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-04
Primary Completion
2022-12-01
Completion
2023-08-29

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03517423 on ClinicalTrials.gov