Drug updated on 12/11/2024
Dosage Form | Tablet (oral; 200 mg, 400 mg, 600 mg, 800 mg) |
Drug Class | Antiepileptics |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of partial-onset seizures in patients 4 years of age and older.
Latest News
Summary
- This summary is based on the review of 12 systematic review(s)/meta-analysis(es). [1-12]
- Cenobamate demonstrated statistically significant higher responder rates (≥50% and 100%) and seizure freedom compared to other new-generation antiseizure medications (ASMs), particularly eslicarbazepine, indicating its superior effectiveness.
- Eslicarbazepine acetate showed a significant ≥50% reduction in seizure frequency, with evidence suggesting increasing efficacy with higher doses, although it was less effective than cenobamate.
- Moderate-certainty evidence indicates that eslicarbazepine may reduce seizure frequency in children aged 6 to 18 years, though the results remain inconclusive.
- Cenobamate was identified as a valuable treatment option for patients with drug-resistant epilepsy, particularly in achieving higher responder rates and improving quality of life compared to third-generation ASMs.
- Eslicarbazepine was associated with treatment-emergent adverse events (TEAEs) such as dizziness, nausea, somnolence, diplopia, and vomiting, and demonstrated a lower patient retention rate compared to placebo.
- Cenobamate exhibited comparable TEAE withdrawal rates to other ASMs, while it had a higher probability of experiencing at least one TEAE compared to some other ASMs, though the differences were not statistically significant.
- Eslicarbazepine showed a higher incidence of serious adverse events and adverse event-related withdrawals compared to placebo, with specific adverse events including vestibulocerebellar symptoms, hyponatremia, and rash, particularly at higher doses.
- Eslicarbazepine may reduce seizure frequency in children aged 6 to 18 years, although the evidence remains inconclusive, while cenobamate is identified as a valuable treatment option for drug-resistant epilepsy (DRE) in adults, showing high efficacy compared to third-generation antiseizure medications.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Aptiom (eslicarbazepine acetate) Prescribing Information. | 2019 | Sumitomo Pharma America, Inc., Marlborough, MA |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Epilepsies in children, young people and adults. | 2022 | NICE |
SIGN159: Epilepsies in children and young people: investigative procedures and management. | 2021 | Healthcare Improvement Scotland |
Evidence-based anti-seizure monotherapy in newly diagnosed epilepsy: a new approach. | 2020 | Acta Neurologica Scandinavica |
Provincial Guidelines for the Management of Epilepsy in Adults and Children. | 2020 | Ontario Brain Institute |