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.

Prior treatment

• Subject planning to enter a clinical trial with a different investigational drug or plan to use any experimental device for treatment of epilepsy or any other medical condition.

Other illness

• Any medical condition, personal circumstance that in the opinion of the investigator exposes the patient to unacceptable risk by participating in the extension study or prevents adherence to the protocol.

Other

• Subject who met any of the withdrawal criteria of the primary study (A_CL_002).
• Female subject who are pregnant, breastfeeding, or planning to become pregnant during the study.

• Written informed consent is signed by the subject and/or their legal representative(s) in accordance with the protocol, ICH GCP and applicable local regulations.
• Subject has successfully completed the Treatment Period of the primary study (A_CL_002) and who maintained at least 80% compliance with the protocol defined dose-regimen (diary completion and IMP administration compliance ≥80%) and did not terminate study drug.
• Subject has no important protocol deviations (e.g., that may impact patient safety, or data integrity) that in the opinion of the sponsor should preclude participation in this study and has no ongoing adverse events (AEs) that, in the opinion of the investigator, would preclude the patient’s entry into this study.
• Subject is expected to experience benefit from their participation, in the opinion of the investigator.
• Female subject of childbearing potential must be willing to comply with the contraception requirements as defined in the protocol.
• Subject or caregiver is willing and able to comply with all study procedures including seizure diary completion.