Cenobamate use for drug-resistant epilepsy in children: A real-world single-center study
Ronny Wickström1, Maria Dahlin1, Mattias Åberg2
1Neuropediatric Unit, Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden; Neuropediatric Unit, Karolinska University Hospital, Stockholm, Sweden.
Insights
Cenobamate effectively treated focal-onset seizures in children, with 60% responding and 12% seizure-free. This epilepsy medication showed a high retention rate and manageable side effects in pediatric patients.
Area of Science:
- Pediatric Neurology
- Epilepsy Treatment
- Pharmacology
Background:
- Cenobamate is approved for adult focal-onset seizures.
- Limited data exists for pediatric use.
- Investigated cenobamate for refractory childhood epilepsy.
Purpose of the Study:
- Evaluate cenobamate efficacy in children.
- Assess dosage, retention, and adverse events.
- Determine suitability for pediatric epilepsy.
Main Methods:
- Prospective data collection in 50 children.
- Real-world, single-center study.
- Reported dosage, efficacy, retention, and adverse effects.
Main Results:
- 60% responder rate (≥50% seizure reduction).
- 12% achieved freedom from major motor seizures.
- 82% retention rate at 12 months; common adverse events: somnolence, nausea, ataxia.
Conclusions:
- Cenobamate shows efficacy and safety in children.
- Findings align with adult data and limited pediatric studies.
- Supports cenobamate use for pediatric epilepsy.
Background:
Cenobamate was approved in 2020 by the EMA for the adjunctive treatment of focal-onset seizures in adults. Based on data from clinical trials and early experience in adult patients, we used cenobamate in children whose seizures were not controlled with available options.
Methods:
We prospectively collected clinical data in patients who started treatment with cenobamate and report dosage, efficacy, retention rate, and adverse effects.
Results:
Overall, 50 patients (median age 12.2 years, range 3.1-18.5, 19 patients below age 10 years; 44% female, median concomitant antiseizure medications 2) were treated with cenobamate for a median duration of 16 months (range 3-28). After gradually increasing cenobamate to clinical effect at a reduced dosage schedule, 60% (29/48) of children were responders (≥50% reduction) and 12% were free of major motor seizures. Patients were treated with an average daily dose of 3.7 mg/kg. During cenobamate treatment, 8 (16%) patients were able to discontinue at least one concomitant antiseizure medication. The retention rate at 12 months was 82%. The most common adverse events were somnolence (42%), nausea/vomiting (4%), and ataxia (4%).
Conclusions:
The findings of this single-center real-world study are in line with prior controlled studies and real-world experience in adult patients, as well as with the limited published experience in children. The efficacy and lack of serious side effects found in this study supports the use of cenobamate as a treatment for epilepsy also in children and infants.
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