Efficacy and tolerability of adjunctive treatment of epilepsy patients with cenobamate: An observational study
- Conditions
- G40.2Localization-related (focal)(partial) symptomatic epilepsy and epileptic syndromes with complex partial seizures
- Registration Number
- DRKS00027568
- Lead Sponsor
- Epilepsiezentrum, Universitätsklinikum Freiburg
- Brief Summary
he clinical cohort included 112 adult patients with 30% nonlesional cases and a wide spectrum of epileptogenic lesions underlying refractory focal epilepsy. We observed a significant reduction in monthly seizure frequency of all seizure types already after 3 months of treatment at a median cenobamate dose of 100 mg/day. Forty-six percent of patients were responders with a =50% seizure reduction, 26% had a =75% seizure reduction, and 9% became seizure-free. Among the 74 patients with available follow-up of 12 months, the responder rates reached 55%, 35%, and 19% for =50%, =75%, and 100% seizure reduction, respectively. After 3 months of treatment, 38% of patients reported adverse effects, mainly (84%) mild to moderate in intensity. Adjustment of comedication allowed successful management of adverse effects in 32% of patients. At a group level, there was no correlation between the cenobamate daily dose and the incidence of adverse events.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 112
1. Patients with partial-onset seizures with or without secondary generalization who are drug resistant to at least 2 previously used antiepileptic drugs
2. Add-on treatment with cenobamate in clinical routine
3. Written informed consent to participate in the trial and ability to adhere to the protocol
1. Genetic epilepsy
2. Drug resistance not yet established
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the treatment efficacy and tolerability of adjunctive treatment with cenobamate.
- Secondary Outcome Measures
Name Time Method To determine the effect of adjunctive cenobamate treatment on (i) laboratory test results and (ii) bone density in the hip and spine.