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.
EU CTIS ID: 2026-525161-40-00
What this study is testing
To assess the long-term safety and tolerability of PTI5803 in patients with drug-resistant seizures associated to FCD.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- Subject who met any of the withdrawal criteria of the primary study (A_CL_002).
- 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.
- Female subject who are pregnant, breastfeeding, or planning to become pregnant during the study.
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.