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Open prospective study on oxcarbazepine in epilepsy in children: a preliminary report
E Franzoni1, C Garone, J Sarajlija
1Child Neuropsychiatry Unit, Bologna University, Italy. emilio.franzoni@unibo.it
Insights
Oxcarbazepine (OXC) is effective and safe for children with epilepsy. Long-term studies show significant seizure reduction and good tolerability, supporting its use as a first-line treatment.
Area of Science:
- Pediatric Neurology
- Clinical Pharmacology
- Epileptology
Background:
- Epilepsy is a common neurological disorder in children.
- Oxcarbazepine (OXC) is an antiepileptic drug with a favorable profile.
- Limited long-term data exists on OXC use in pediatric epilepsy populations.
Purpose of the Study:
- To assess the long-term efficacy, tolerability, and safety of oxcarbazepine (OXC) monotherapy.
- To evaluate OXC's effectiveness in children with newly diagnosed partial epilepsy.
- To correlate metabolite levels with clinical outcomes in pediatric epilepsy patients.
Main Methods:
- An open-label, prospective study involving 36 children with newly diagnosed partial epilepsy.
- Patients received OXC monotherapy with follow-up at 3, 12, and 24 months.
- Seizure diaries, side effect questionnaires, metabolite levels (10-monohydroxy), and laboratory analyses were used for evaluation.
Main Results:
- At 3 months, 58.3% of patients were seizure-free, with continued efficacy at 24 months (72.2% seizure-free in a subset).
- A correlation between 10-monohydroxy metabolite levels and clinical response was observed at 3 months.
- Side effects were reported in 25% of patients but were transient and resolved over time; 25% EEG normalization was observed.
Conclusions:
- Oxcarbazepine (OXC) demonstrates sustained efficacy and favorable safety in children with epilepsy.
- The drug is well-tolerated, with manageable side effects.
- OXC can be considered a safe and effective first-line antiepileptic drug for pediatric epilepsy.
Purpose:
To evaluate the long-term efficacy, tolerability, and safety of oxcarbazepine (OXC) in children with epilepsy.
Methods:
We enrolled 36 patients (median age 7.75) with new diagnosis of partial epilepsy in an open prospective study. All type of epilepsy were included: 25 patients were affected by idiopathic epilepsy, eight by symptomatic epilepsy and three by cryptogenic epilepsy. Patients were then scheduled to come back for controls at 3 months (T1), 12 months (T2) and 24 months (T3) after the beginning of OXC-monotherapy (T0). At each control we evaluated patients through their seizure diary, a questionnaire on side effects, their level of 10-monohydroxy (MHD) metabolite and laboratory analysis.
Results:
At T1, 21/36 patients (58.3%) were seizure-free, 3/36 patients (8.3%) showed an improvement higher than 50%, 3/36 (8.3%) lower than 50%, while 2/36 worsened (5.6%). In 7/36 (19.5%) patients, no improvement was reported. At T2 13/18 patients (72.2%) were seizure-free, 1/18 showed a response to therapy higher than 50% while 2/18 worsened (11%). In two patients no improvement was reported. A correspondence between MHD plasmatic levels and clinical response (r=0.49; p<0.05) was only registered at T1. An EEG normalization was observed in 25% of cases. Side effects were reported in 25% of cases, but symptoms progressively disappeared at follow-up.
Conclusions:
We can therefore conclude that OXC can be considered, for its efficacy and safety, as a first line drug in children with epilepsy.
