epilepsy epilepsy
Conditions
Interventions
This is an observational study, there is no intervention. 
Cenobamate will be initiated based on standard of care. Questionnaires will be answered by the proxy. 
Sponsors
Farmaceutisch bedrijf, Angelini Pharma France SAS
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: To be eligible to participate in the prospective study, a patient must meet all of the following criteria: - Aged 18-75 years - Diagnosed with (multi)focal onset seizures. - Presence of intellectual disability, either formally diagnosed or estimated by the treating physician. - Have been recommended starting with cenobamate by the treating physician based on medical need according to standard of care. - Be able to provide informed consent if considered competent, or have consent provided by a legal representative. A proxy must meet all of the following criteria: be adult (=18 years old); Be either an informal (unpaid) caregiver, or a formal (paid) caregiver to the patient, providing emotional, practical, and/or physical support. This caregiver should see the patient on a regular basis, preferably a few times per week Be able to complete the questionnaires at the four predefined data collection points over the duration of the study (10 months) For the retrospective chart analysis, we will select patients who meet the following criteria: - Aged 18-75 years - Diagnosed with (multi)focal onset seizures. - Presence of intellectual disability, either formally diagnosed or estimated by the treating physician. - Has initiated cenobamate based on medical need according to standard of care.
Exclusion criteria
Exclusion criteria: To be able to complete study procedures and proxy-assessments for the prospective study, mastery of Dutch or English is required. People who do not sufficiently understand either Dutch of English will therefore be excluded. This exclusion criterion is not applicable to the retrospective cohort as only medical record data will be used.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Differences in outcomes of the Behavior and Mood scales after titration compared to baseline (utilizing questionnaire-based assessment). | — |
Secondary
| Measure | Time frame |
|---|---|
| Seizure frequency (reduction of 50% or more) and drug load (percentage change in daily defined dose (DDD) of anti-seizure medication and psychiatric medication compared to baseline. Somatic side effects such as headache, sedation and dizziness. | — |
Countries
Netherlands
Contacts
Public ContactH.F. Thuijl
Stichting Epilepsie Instellingen Nederland (SEIN)
Outcome results
None listed