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Clobazam as add-on therapy in children with epileptic encephalopathy
Rosana Carvalho Silva1, Maria Augusta Montenegro, Carlos A M Guerreiro
1Department of Neurology, State University of Campinas, São Paulo, Brazil.
Insights
Clobazam is a safe and effective add-on treatment for childhood epileptic encephalopathies. This study found it reduced seizures in many young patients, with lasting benefits for most.
Area of Science:
- Pediatric Neurology
- Epileptology
- Clinical Pharmacology
Background:
- Clobazam is an established treatment for partial epilepsy in adults and children.
- Epileptic encephalopathies in children represent a significant therapeutic challenge.
Purpose of the Study:
- To assess the safety and efficacy of clobazam as adjunctive therapy.
- To evaluate clobazam's role in managing pediatric epileptic encephalopathies.
Main Methods:
- Retrospective analysis of 97 children (<18 years) with epileptic encephalopathy.
- Clobazam administered as add-on therapy with dose titration up to maximum tolerated levels.
- Data collected from clinical files and follow-up visits.
Main Results:
- 41% of patients experienced mild, transient adverse events; only 11% required clobazam withdrawal.
- 9.2% achieved seizure freedom, and 27.8% showed >50% seizure reduction.
- Long-term seizure improvement (>1 year) was observed in 85% of responders.
Conclusions:
- Clobazam demonstrates a favorable safety profile in pediatric epileptic encephalopathies.
- Adjunctive clobazam therapy is effective in reducing seizure frequency in this population.
- The findings support clobazam's utility for managing severe childhood epilepsy syndromes.
Rationale:
Clobazam has been used successfully in adults and children with partial epilepsy. The purpose of this study was to evaluate the safety and efficacy of clobazam as add-on therapy in children with epileptic encephalopathy.
Methods:
This was a retrospective study conducted at the pediatric epilepsy clinic of our university hospital. Children less than 18-years of age with epileptic encephalopathy were included in the study. Clobazam was introduced as add-on therapy, starting with 5 mg/Kg/day and increased in minimally effective doses, up to the maximum tolerated dose. Data were obtained from clinical files and follow-up visits.
Results:
Ninety-seven patients were included in the study (39 girls), aged between 1 and 17-years-old (mean = 9.9). Twenty-six patients had Lennox-Gastaut syndrome, seven had myoclonic astatic epilepsy, nine had West syndrome and, in 57 patients, the type of epileptic encephalopathy could not be determined. Clobazam dosage ranged from 5 to 60 mg/day (mean = 37.5 mg/day). Forty (41%) patients presented with adverse events, most of which were mild and transitory, and clobazam needed to be withdrawn in only 11 patients. Nine (9.2%) patients were seizure-free after clobazam adjunctive therapy. In 11 (11.3%) patients seizure improvement was >75%, in 16 (16.5%) it was >50%, in 17 (17.5%) improvement was <50% and in 44 (45.5%) there was no change in seizure frequency. Three patients were lost to follow-up. In 85% of the patients with seizure improvement, the results lasted for more than one year.
Conclusion:
Clobazam is safe and effective in the treatment of epileptic encephalopathies of childhood.
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