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/AClinical Study ID
NCT05859854
153(A)IM21348
Ages 18-99 All Genders
Study Summary
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
Connect with a study center
IRCCS Neuromed
Pozzilli, Isernia 86077
ItalyActive - Recruiting
Associazione La Nostra Famiglia - IRCCS Eugenio Medea
Conegliano, Treviso 31015
ItalyActive - Recruiting
Policlinico di Bari
Bari, 70124
ItalyActive - Recruiting
Università degli Studi di Catanzaro "Magna Graecia"
Catanzaro, 88100
ItalyActive - Recruiting
Fondazione Istituto Neurologico Casimiro Mondino
Pavia, 27100
ItalyActive - Recruiting
Campus Bio-Medico
Roma, 00128
ItalyActive - Recruiting
Policlinico Umberto I
Roma, 00161
ItalyActive - Recruiting
Humanitas Gradenigo
Torino, 10153
ItalyActive - Recruiting
Azienda Sanitaria Universitaria (A.O.U.) Integrata
Udine, 33100
ItalyActive - Recruiting
Ospedale San Bortolo
Vicenza, 36100
ItalyActive - Recruiting
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