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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05859854
Study type Observational
Source Aziende Chimiche Riunite Angelini Francesco S.p.A
Contact Valentina Villano, MD
Phone +390691045340
Email valentina.villano@angelinipharma.com
Status Recruiting
Phase
Start date January 24, 2023
Completion date September 30, 2025

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