Brivaracetam: a Prospective and Multicentre Post-marketing Observational Study

NCT03517423 | Completed

• 1 other identifier: MP-02-2-18-6766
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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

Epilepsy

Keywords

brivaracetam; post-marketing observational study

Outcome Measures

Primary Outcomes (2)

• mean percent change in monthly seizure frequency

  change in frequency of any seizures

  3 and 6 months

• proportion with at least a 50% change in seizure frequency

  otherwise referred to as the "responder rate"

  3 and 6 months

Secondary Outcomes (7)

• the proportion of individuals that are seizure free

  3 and 6 months

• mean change in irritability

  3 and 6 months

• mean change in generalised anxiety

  3 and 6 months

• mean change in depression

  3 and 6 months

• mean change in quality of life

  3 and 6 months

Interventions

Brivaracetam DRUG

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.

Also known as: BRV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Data will be collected from participants during three clinical visits with their regular treating physician (MD). These will be the baseline visit, the 3-month visit (three months following the initiation of brivaracetam), and the 6-month visit. The baseline visit will be the regularly scheduled clinical visit where the MD will decide to begin brivaracetamin their patient.

You may qualify if:

• All consecutive adult patients (i.e. aged at least 18 years) with focal epilepsy in whom BRV was introduced (no more than 48 hours prior to their time of recruitment) at participating medical centres, ambulatory or hospitalized, will be approached to participate in the study.

You may not qualify if:

• We will exclude individuals with generalized epilepsy as well as those aged less than 18 years, in order to respect current Health Canada indications. We will exclude individuals cognitively or physically unable to complete the study questionnaires.

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• UCB Pharma: collaborator

Study Sites (1)

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2X0C1, Canada

Location

Related Publications (16)

• Ben-Menachem E, Mameniskiene R, Quarato PP, Klein P, Gamage J, Schiemann J, Johnson ME, Whitesides J, McDonough B, Eckhardt K. Efficacy and safety of brivaracetam for partial-onset seizures in 3 pooled clinical studies. Neurology. 2016 Jul 19;87(3):314-23. doi: 10.1212/WNL.0000000000002864. Epub 2016 Jun 22.

  PMID: 27335114 BACKGROUND

• Ryvlin P, Werhahn KJ, Blaszczyk B, Johnson ME, Lu S. Adjunctive brivaracetam in adults with uncontrolled focal epilepsy: results from a double-blind, randomized, placebo-controlled trial. Epilepsia. 2014 Jan;55(1):47-56. doi: 10.1111/epi.12432. Epub 2013 Oct 28.

  PMID: 24256083 BACKGROUND

• Klein P, Schiemann J, Sperling MR, Whitesides J, Liang W, Stalvey T, Brandt C, Kwan P. A randomized, double-blind, placebo-controlled, multicenter, parallel-group study to evaluate the efficacy and safety of adjunctive brivaracetam in adult patients with uncontrolled partial-onset seizures. Epilepsia. 2015 Dec;56(12):1890-8. doi: 10.1111/epi.13212. Epub 2015 Oct 16.

  PMID: 26471380 BACKGROUND

• Biton V, Berkovic SF, Abou-Khalil B, Sperling MR, Johnson ME, Lu S. Brivaracetam as adjunctive treatment for uncontrolled partial epilepsy in adults: a phase III randomized, double-blind, placebo-controlled trial. Epilepsia. 2014 Jan;55(1):57-66. doi: 10.1111/epi.12433. Epub 2013 Nov 8.

  PMID: 24446953 BACKGROUND

• Delgado-Rodriguez M, Llorca J. Bias. J Epidemiol Community Health. 2004 Aug;58(8):635-41. doi: 10.1136/jech.2003.008466.

  PMID: 15252064 BACKGROUND

• Holtzman S, O'Connor BP, Barata PC, Stewart DE. The Brief Irritability Test (BITe): a measure of irritability for use among men and women. Assessment. 2015 Feb;22(1):101-15. doi: 10.1177/1073191114533814. Epub 2014 May 15.

  PMID: 24830513 BACKGROUND

• Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

  PMID: 16717171 BACKGROUND

• Micoulaud-Franchi JA, Lagarde S, Barkate G, Dufournet B, Besancon C, Trebuchon-Da Fonseca A, Gavaret M, Bartolomei F, Bonini F, McGonigal A. Rapid detection of generalized anxiety disorder and major depression in epilepsy: Validation of the GAD-7 as a complementary tool to the NDDI-E in a French sample. Epilepsy Behav. 2016 Apr;57(Pt A):211-216. doi: 10.1016/j.yebeh.2016.02.015. Epub 2016 Mar 16.

  PMID: 26994447 BACKGROUND

• Gilliam FG, Barry JJ, Hermann BP, Meador KJ, Vahle V, Kanner AM. Rapid detection of major depression in epilepsy: a multicentre study. Lancet Neurol. 2006 May;5(5):399-405. doi: 10.1016/S1474-4422(06)70415-X.

  PMID: 16632310 BACKGROUND

• Micoulaud-Franchi JA, Barkate G, Trebuchon-Da Fonseca A, Vaugier L, Gavaret M, Bartolomei F, McGonigal A. One step closer to a global tool for rapid screening of major depression in epilepsy: validation of the French NDDI-E. Epilepsy Behav. 2015 Mar;44:11-6. doi: 10.1016/j.yebeh.2014.12.011. Epub 2015 Jan 16.

  PMID: 25597527 BACKGROUND

• Cramer JA, Perrine K, Devinsky O, Meador K. A brief questionnaire to screen for quality of life in epilepsy: the QOLIE-10. Epilepsia. 1996 Jun;37(6):577-82. doi: 10.1111/j.1528-1157.1996.tb00612.x.

  PMID: 8641236 BACKGROUND

• Picot MC, Crespel A, Daures JP, Baldy-Moulinier M, El Hasnaoui A. Psychometric validation of the French version of the quality of life in epilepsy inventory (QOLIE-31): comparison with a generic health-related quality of life questionnaire. Epileptic Disord. 2004 Dec;6(4):275-85.

  PMID: 15634625 BACKGROUND

• Maneesriwongul W, Dixon JK. Instrument translation process: a methods review. J Adv Nurs. 2004 Oct;48(2):175-86. doi: 10.1111/j.1365-2648.2004.03185.x.

  PMID: 15369498 BACKGROUND

• Steinhoff BJ, Somerville ER, Van Paesschen W, Ryvlin P, Schelstraete I. The SKATE study: an open-label community-based study of levetiracetam as add-on therapy for adults with uncontrolled partial epilepsy. Epilepsy Res. 2007 Aug;76(1):6-14. doi: 10.1016/j.eplepsyres.2007.06.002. Epub 2007 Aug 6.

  PMID: 17681453 BACKGROUND

• Morrell MJ, Leppik I, French J, Ferrendelli J, Han J, Magnus L. The KEEPER trial: levetiracetam adjunctive treatment of partial-onset seizures in an open-label community-based study. Epilepsy Res. 2003 May;54(2-3):153-61. doi: 10.1016/s0920-1211(03)00080-9.

  PMID: 12837566 BACKGROUND

• Vittinghoff E, McCulloch CE. Relaxing the rule of ten events per variable in logistic and Cox regression. Am J Epidemiol. 2007 Mar 15;165(6):710-8. doi: 10.1093/aje/kwk052. Epub 2006 Dec 20.

  PMID: 17182981 BACKGROUND

MeSH Terms

Conditions

Epilepsy

Interventions

brivaracetam

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Mark R Keezer, MDCM PhD

  CHUM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2018
• First Posted: May 7, 2018
• Study Start: October 4, 2018
• Primary Completion: December 1, 2022
• Study Completion: August 29, 2023
• Last Updated: December 19, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)