OBJECTIVES: The European Medicines Agency concluded that results of studies for treatments of partial onset seizures (POS) in adults could be extrapolated to the pediatric population. An example is lacosamide, an anti-epileptic drug (AED), that recently obtained indication extension for treatment in children aged > METHODS: A systematic literature review was conducted to identify randomized, open-label or double-blind, placebo- and/or active-controlled trials of regimens indicated for the pediatric population. A feasibility assessment investigating the viability of an ITC of efficacy/safety outcomes was undertaken to assess a) whether relevant treatments can be connected in an interlinked network of evidence, b) whether the similarity assumption holds. Outcomes of interest included: seizure freedom at 6/12 months, seizure frequency reduction, adverse events, and patient reported outcomes.

RESULTS: A total of 26 studies, reporting 18 unique clinical trials, met the inclusion criteria. Seven assessed AEDs in monotherapy and 11 in adjunctive therapy. The already small networks of evidence (2-4 trials in mono, 2-7 in adjunctive therapy) lacked the statistical power to provide robust estimates for the few sufficiently reported outcomes of interest (4 in mono, and 7 in adjunctive therapy). The feasibility assessment revealed that heterogeneity between studies was present on each assessed attribute (PICOS; population, intervention and comparator, outcomes, study design) with underreporting evidence and potential effect modification being key observations.

CONCLUSIONS

: An ITC-based comparative analysis between AEDs for POS is not likely to be viable, due to small or broken evidence networks and substantial between-study heterogeneity. Healthcare policy decision-makers should explore alternative means to assess the comparative value of AEDs in treating POS in pediatrics.