An observational study in Focal Onset Seizure and Epilepsy, sponsored by Aziende Chimiche Riunite Angelini Francesco S.p.A. Completed at 23 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-09.
Sponsored by Aziende Chimiche Riunite Angelini Francesco S.p.A · Observational
Cenobamate is a newly-FDA and EMA approved drug used to treat -focal-onset seizures in adult patients.
The aim of the current study is to analyse retrospectively the overall effectiveness and tolerability of cenobamate from real-world data collected in patients who partecipated in the Early Access Program (EAP) and were treated with cenobamate as adjunctive ASM.
Cenobamate is a new approved drug used to treat -focal-onset seizures in adult patients. This novel tetrazole-derived carbamate seems to act primarily by two mechanisms that are commonly associated with epilepsy: cenobamate acts as a positive allosteric modulator of the GABAA ion channels and is effective in reducing repetitive neuronal firing by inhibition of voltage-gated sodium channels, although the complete mechanism of action is currently unknown.
In clinical trials, cenobamate showed also low toxicity and adverse drug reaction profile.
In European Union (EU), cenobamate received the marketing authorisation, valid throughout the EU, in March 2021. Starting from September 2020 an EAP was initiated with cenobamate as adjunctive ASM in several EU Countries such as Germany, France, and UK.
Real-world data are of importance to understand and confirm the efficacy and safety profile of drugs outside of the clinical trial setting. The aim of the current study is to analyse the overall effectiveness and tolerability of cenobamate from real-world data in a large series of patients treated with cenobamate as adjunctive ASM.
As a consequence, a retrospective collection and analysis of the data of the patients who participated in the EAP, according to the authorization received from the local regulatory or ethic authorities, was conducted.
1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.
This study's enrollment of 319 is above the median of 102 across 521 observational studies indexed under Epilepsy.
Browse Epilepsy studies →Aziende Chimiche Riunite Angelini Francesco S.p.A is the lead sponsor of 40 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population includes adult patients suffering from epilepsy with FOS who have been treated with cenobamate as adjunctive Anti-seizure medication (ASM) during the EAP in Germany, France and UK.
Exclusion Criteria:
Cohort of patients suffering from epilepsy with Focal Onset Seizure (FOS) and enrolled into the Early Access Program (EAP) in Germany, France and UK
Responder rate (%) at 3 months from the start of maintenance
Percentage of responder rate (defined as a ≥50% reduction from screening/baseline in focal onset seizure frequency) after 3 months of maintenance phase.
Time frame: 3 months from the start of maintenance
Portion of responders
Portion of responders (defined as a ≥50% and \<100% reduction from screening/baseline in focal onset seizure frequency) at 1 and 3 months after start of cenobamate therapy
Time frame: 1 and 3 months after start of cenobamate therapy
Portion of responders
Portion of responders (defined as a ≥50% and \<100% reduction from screening/baseline in focal onset seizure frequency) at 3, 6 and 12 months after the completion of the titration and its relation with the dosage.
Time frame: 3, 6 and 12 months after the completion of the titration and its relation with the dosage.
Portion of seizure free
Portion of seizure free (100% reduction from screening/baseline) 1 and 3 months after start of cenobamate therapy
Time frame: 1 and 3 months after start of cenobamate therapy
Portion of seizure free
Portion of seizure free (100% reduction from screening/baseline)3, 6 and 12 months after the completion of the titration and its relation with the dosage.
Time frame: 3, 6 and 12 months after the completion of the titration and its relation with the dosage.
Retention rate
Retention rate measured as percentage of patients remaining in the study and on adjunctive therapy at: 1 and 3 months after start of cenobamate therapy
Time frame: 1 and 3 months after start of cenobamate therapy
Retention rate
Retention rate measured as percentage of patients remaining in the study and on adjunctive therapy at 3, 6 and 12 months after the completion of the titration and its relation with the dosage.
Time frame: 3, 6 and 12 months after the completion of the titration
No. of Adverse Reactions (ADRs),
Adverse Reactions (ADRs), including DRESS, rash/hypersensitivity occurred during the EAP.
Time frame: Through study completion, an average of 2 years
Change in Seizures Frequency
Change in Seizures Frequency at 1 and 3 months after start of cenobamate therapy,
Time frame: 1 and 3 months after start of cenobamate therapy
Change in Seizures Frequency
Change in Seizures Frequency at 3, 6 and 12 months after the completion of the titration
Time frame: 3, 6 and 12 months after the completion of the titration
Assessment of quality of life
The quality of life was assessed through the Questionnaire Quality of Life in Epilepsy Inventory - 31 items
Time frame: 1 and 3 months after start of cenobamate therapy
Assessment of quality of life
The quality of life was assessed through the Questionnaire Quality of Life in Epilepsy Inventory - 31 items
Time frame: 3, 6 and 12 months after the completion of the titration
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Aziende Chimiche Riunite Angelini Francesco S.p.A