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Efficacy and tolerability of vigabatrin in children with refractory partial seizures: a single-blind dose-increasing
B Dalla Bernardina1, E Fontana, F Vigevano
1Cattedra di Neuropsichiatria Infantile, Ospedale Borgo Roma, Verona, Italy.
Insights
Vigabatrin (VGB) effectively reduced refractory partial epilepsy seizures in children. This add-on treatment showed significant seizure reduction and tolerability, with some patients achieving seizure freedom.
Area of Science:
- Neurology
- Pediatric Epilepsy
Background:
- Refractory partial epilepsy in children poses significant treatment challenges.
- Evaluating new therapeutic options is crucial for improving patient outcomes.
Purpose of the Study:
- To assess the efficacy and tolerability of vigabatrin (VGB) as an add-on therapy for pediatric refractory partial epilepsy.
- To determine the optimal dosage and response rates of VGB in this patient population.
Main Methods:
- A single-blind, add-on, fixed-sequence, placebo-controlled trial.
- 46 children with refractory partial epilepsy were enrolled.
- Patients received placebo followed by VGB at escalating doses (40, 60, 80 mg/kg/day) over a 7-month treatment period.
Main Results:
- A significant decrease in monthly seizure frequency was observed, from 97 during placebo to 9 after 6 months of VGB treatment (p < 0.0001).
- 35 out of 39 patients (completing the study) experienced over 50% seizure reduction by 6 months.
- Eight patients achieved seizure freedom with VGB treatment, with no significant changes in most concomitant antiepileptic drug serum levels, except for phenytoin.
Conclusions:
- Vigabatrin demonstrates significant efficacy in reducing seizure frequency in children with refractory partial epilepsy.
- VGB is a well-tolerated add-on treatment option, with a notable proportion of patients achieving seizure freedom.
- Further research may explore long-term outcomes and optimal VGB dosing strategies in pediatric epilepsy.
Abstract:
The efficacy and tolerability of vigabatrin (VGB) in children with refractory partial epilepsy were assessed in a single-blind, add-on, fixed-sequence, placebo-controlled trial. After 1-month observation, the patients entered a 7-month treatment period that involved administration of placebo for 1 month followed by VGB at the initial dosage of 40 mg/kg/day, to be increased to 60 and 80 mg/kg/day at 2-month intervals if seizures persisted. Of the 46 children enrolled in the study, 7 dropped out prematurely due to lack of efficacy of the drug (n = 6) or increased seizure frequency (n = 1). In 11 patients who either became seizure-free (n = 3) or improved markedly (n = 8), treatment was completed at a dose < 80 mg/kg/day. The average number of seizures per month in the 39 patients who completed the study decreased from 97 during placebo to 21, 12, and 9 after 2, 4, and 6 months of VGB treatments respectively (p < 0.0001 at each time). Response to VGB remained statistically significant when dropouts were included in the evaluation. The number of patients who had > 50% reduction in seizure frequency after 2, 4, and 6 months was 28, 33, and 35, respectively. Eight patients became seizure-free during the last 2 months of VGB treatment (3 at 40, 3 at 60, and 2 at 80 mg/kg/day, as compared with none during placebo treatment). Serum levels of associated antiepileptic drugs (AEDs) showed no significant changes, except for serum phenytoin (PHT) concentration, which significantly (p < 0.01) decreased after VGB treatment.(ABSTRACT TRUNCATED AT 250 WORDS)