PTI5803

A Phase 2a, multi centric, open label clinical study to explore the safety and tolerability, the pharmacokinetics and pharmacodynamics profile and first signs of efficacy of PTI5803 administered as adjunctive therapy with a 3-dose escalation regimen in patients >= 14 years of age with drug-resistant seizures associated to focal cortical dysplasia, followed by an optional open-label extension study.

A Multicenter, Open-Label, Long-Term, Safety and Tolerability Extension Study of PTI5803 as adjunctive therapy in patients ≥ 14 years of age with drug-resistant seizures associated to focal cortical dysplasia.