Cenobamate in Adults With Focal-Onset Seizures

Last updated: February 7, 2024
Sponsor: Aziende Chimiche Riunite Angelini Francesco S.p.A
Overall Status: Active - Recruiting

Phase

N/A

Condition

Epilepsy

Metachromatic Leukodystrophy - Mld

Kleptomania

Treatment

N/A

Clinical Study ID

NCT05859854
153(A)IM21348
  • Ages 18-99
  • All Genders

Study Summary

The BLESS Study contributes to filling this information gap by collecting data from the Italian clinical practice and the Compassionate Use Program, to better characterize the clinical profile of cenobamate describing its effectiveness, safety and tolerability in adult patients diagnosed with uncontrolled focal epilepsy despite the use of at least two antiepileptic medicinal products.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥18 years at the time of cenobamate treatment initiation
  • Male or female patients
  • Patients diagnosed with focal epilepsy uncontrolled despite a history of treatmentwith at least two antiepileptic medicinal products at the time of cenobamate treatmentinitiation in agreement with the Summary of Product Characteristics (SmPC)
  • Patients who at enrolment had received at least 12 weeks (titration period up to theinitial recommended target dose of 200 mg daily completed) but no more than 52 weeksof cenobamate as adjunctive treatment of focal-onset seizures with or withoutsecondary generalization
  • Patients with available retrospective data in medical charts and seizure diaries,including information about baseline seizure frequency prior to cenobamate treatmentinitiation
  • Patients who gave written informed consent to take part into the study and personaldata processing consent following local regulation.
  • Patients who received adjunctive cenobamate for at least 12 weeks and discontinuedpermanently treatment before enrolment will also be included in the study-

Exclusion

Exclusion Criteria:

  • Patients diagnosed with familial short-QT syndrome
  • Patients affected by hypersensitivity to the active substance cenobamate or to any ofthe excipients (e.g., lactose monohydrate)
  • Patients with history of severe drug-induced hypersensitivity reaction, including (butnot limited to) drug reaction with eosinophilia and systemic symptoms (DRESS), andStevens Johnson syndrome
  • Patients enrolled in a clinical trial in which treatments for epilepsy are managedthrough a study protocol
  • Patient unable to read and write in Italian language and to autonomously fill inquestionnaires and scales
  • Patients with a known pregnancy or who are breast-feeding from cenobamate treatmentinitiation till enrolment visit.

Study Design

Total Participants: 1200
Study Start date:
January 24, 2023
Estimated Completion Date:
September 30, 2025

Study Description

The main objective of the study is to describe the effectiveness of adjunctive cenobamate treatment in adult patients with uncontrolled focal epilepsy in Italy, overall and according to age class, setting of cenobamate treatment, cenobamate final target daily dose prescribed, and number of concomitant Anti Seizure Medications (ASMs). This will be assessed by intra-patient percent change and achievement of a ≥50% reduction in the seizure frequency from the pre-treatment baseline over a period of 52 weeks.

Connect with a study center

  • IRCCS Neuromed

    Pozzilli, Isernia 86077
    Italy

    Active - Recruiting

  • Associazione La Nostra Famiglia - IRCCS Eugenio Medea

    Conegliano, Treviso 31015
    Italy

    Active - Recruiting

  • Policlinico di Bari

    Bari, 70124
    Italy

    Active - Recruiting

  • Università degli Studi di Catanzaro "Magna Graecia"

    Catanzaro, 88100
    Italy

    Active - Recruiting

  • Fondazione Istituto Neurologico Casimiro Mondino

    Pavia, 27100
    Italy

    Active - Recruiting

  • Campus Bio-Medico

    Roma, 00128
    Italy

    Active - Recruiting

  • Policlinico Umberto I

    Roma, 00161
    Italy

    Active - Recruiting

  • Humanitas Gradenigo

    Torino, 10153
    Italy

    Active - Recruiting

  • Azienda Sanitaria Universitaria (A.O.U.) Integrata

    Udine, 33100
    Italy

    Active - Recruiting

  • Ospedale San Bortolo

    Vicenza, 36100
    Italy

    Active - Recruiting

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