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.

Condition studied

Drug resistant focal epilepsy related to focal cortical dysplasia

Investigational medicinal product(s)

Eligibility

Primary endpoint

Adverse events, Clinically significant findings in physical examinations, vital signs, body weight and height, laboratory tests or 12-lead ECGs., Increase in suicide risk as assessed by the C-SSRS.

Endpoint detail

Change from primary study baseline in the CGI-C, PGI-C, CGI-S and PGI-S scores., Change from primary study baseline in the QOLIE-31 for adults and QOLIEAD- 48 for adolescents scores., Change from primary study baseline in the BDI-II scores., Based on seizure diary data with Baseline defined as the period before receiving study medication in the previous study (A_CL_002): - Mean percent change from baseline in monthly (28 days) seizures frequency. - Proportion of seizure free subjects per 28 days compared to baseline., Percentage of the cohort still on medication at months 6, 12, 18 and 24.