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Adjunctive lamotrigine for partial seizures in patients aged 1 to 24 months
J E Piña-Garza1, P Levisohn, K Gucuyener
1Vanderbilt University, Children's Hospital at Vanderbilt, Nashville, TN 37232-9559, USA. eric.pina-garza@Vanderbilt.edu
Insights
Adjunctive lamotrigine showed potential efficacy in treating partial seizures in infants aged 1 to 24 months. This epilepsy medication was well-tolerated, with a trend towards fewer treatment failures compared to placebo.
Area of Science:
- Pediatric Neurology
- Epileptology
- Clinical Pharmacology
Background:
- Partial seizures in infants (1-24 months) present a significant treatment challenge.
- Limited data exist on the efficacy and tolerability of specific antiepileptic drugs in this age group.
- Adjunctive therapy is often necessary for managing refractory epilepsy in infants.
Purpose of the Study:
- To evaluate the efficacy and tolerability of adjunctive lamotrigine for partial seizures in infants.
- To compare lamotrigine's effectiveness against placebo in a randomized, double-blind, controlled trial.
- To assess seizure frequency reduction and time to treatment failure.
Main Methods:
- Responder-enriched, randomized, double-blind, placebo-controlled trial.
- 177 infants received open-label lamotrigine; responders (n=38) were randomized to lamotrigine or placebo for 8 weeks.
- Dose adjustments were based on concomitant antiepileptic drugs (AEDs).
Main Results:
- A trend towards lower treatment failure rates with lamotrigine (58%) versus placebo (84%) was observed (primary analysis not significant, post hoc p=0.045).
- Median time to escape criteria was longer with lamotrigine (42 days) than placebo (22 days) (p=0.059).
- Adjunctive lamotrigine demonstrated additional seizure reduction in a subset of patients during the double-blind phase.
Conclusions:
- Lamotrigine was well-tolerated in infants aged 1 to 24 months with partial seizures.
- The study suggests potential efficacy of adjunctive lamotrigine for this indication.
- Further research may be warranted to confirm efficacy in this pediatric population.
Objective:
This randomized, double-blind, placebo-controlled trial was conducted to assess the efficacy and tolerability of adjunctive lamotrigine for the treatment of partial seizures in infants aged 1 to 24 months.
Methods:
The study used a responder-enriched design in which all patients received adjunctive lamotrigine during an open-label phase (n = 177; maximum maintenance dose 5.1 mg/kg/day for those on non-enzyme-inducing antiepileptic drugs [AEDs] or valproate and 15.6 mg/kg/day for those on enzyme-inducing AEDs). Patients meeting response criteria were randomly assigned to double-blind treatment for up to 8 weeks with continued lamotrigine (n = 19) or to withdrawal from lamotrigine (placebo; n = 19) while background AEDs were maintained.
Results:
The proportion of treatment failures (patients who met escape criteria or withdrew before completing the double-blind phase) was lower with lamotrigine (58%) than with placebo (84%). This finding was not significant in the primary analysis (two-sided chi(2) test [primary endpoint]). A post hoc sensitivity analysis of the primary endpoint was also performed (p = 0.045 by one-sided, mid-p corrected Fisher exact test). The median time to meet escape criteria was longer with lamotrigine (42 days) than with placebo (22 days) (p = 0.059). During the last 28 days of the open-label phase, 53% of the patients had a >or=50% reduction in frequency of partial seizures with lamotrigine. Additional reduction in partial seizure frequency was observed during the double-blind phase compared with the last 4 weeks of the open-label phase among those randomly assigned to lamotrigine (32% with a >or=25% reduction) but not those randomly assigned to placebo (5% with a >or=25% reduction). Lamotrigine was well tolerated, with an adverse event profile comparable to that observed in older pediatric patients.
Conclusion:
Lamotrigine was well tolerated, and the data indicate that it may be efficacious in the treatment of partial seizures in infants aged 1 to 24 months.
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