Phase
Condition
Sjögren-larsson Syndrome
Epilepsy
Metachromatic Leukodystrophy - Mld
Treatment
N/AClinical Study ID
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 cenobamatetreatment initiation 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 anyof the excipients (e.g., lactose monohydrate)
Patients with history of severe drug-induced hypersensitivity reaction, including (but not limited to) drug reaction with eosinophilia and systemic symptoms (DRESS),and Stevens 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
Study Description
Connect with a study center
Policlinico di Bari
Bari 3182351, Bari 70124
ItalySite Not Available
Università degli Studi di Catanzaro "Magna Graecia"
Catanzaro 2525059, Catanzaro 88100
ItalySite Not Available
IRCCS Neuromed
Pozzilli, Isernia 86077
ItalySite Not Available
IRCCS Neuromed
Pozzilli 3170006, Isernia 86077
ItalySite Not Available
Fondazione Istituto Neurologico Casimiro Mondino
Pavia 3171366, Pavia 27100
ItalySite Not Available
Campus Bio-Medico
Roma 8957247, Roma 00128
ItalySite Not Available
Policlinico Umberto I
Roma 8957247, Roma 00161
ItalySite Not Available
Humanitas Gradenigo
Torino 8980539, Torino 10153
ItalySite Not Available
Associazione La Nostra Famiglia - IRCCS Eugenio Medea
Conegliano, Treviso 31015
ItalySite Not Available
Associazione La Nostra Famiglia - IRCCS Eugenio Medea
Conegliano 3178197, Treviso 31015
ItalySite Not Available
Azienda Sanitaria Universitaria (A.O.U.) Integrata
Udine 3165072, Udine 33100
ItalySite Not Available
Ospedale San Bortolo
Vicenza 3164419, Vicenza 36100
ItalySite Not Available
Policlinico di Bari
Bari, 70124
ItalySite Not Available
Università degli Studi di Catanzaro "Magna Graecia"
Catanzaro, 88100
ItalySite Not Available
Fondazione Istituto Neurologico Casimiro Mondino
Pavia, 27100
ItalySite Not Available
Campus Bio-Medico
Roma, 00128
ItalyActive - Recruiting
Policlinico Umberto I
Roma, 00161
ItalySite Not Available
Humanitas Gradenigo
Torino, 10153
ItalySite Not Available
Azienda Sanitaria Universitaria (A.O.U.) Integrata
Udine, 33100
ItalySite Not Available
Ospedale San Bortolo
Vicenza, 36100
ItalySite Not Available

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