A Long-term Study of the Safety and Effectiveness of RAP-219 in Adults With Focal Onset Seizures

An Open-label, Long-term Study Evaluating RAP-219 in Adult Participants With Refractory Onset Seizures

This is a clinical research study for an investigational drug called RAP-219 in patients with Refractory Focal Epilepsy. This study is being conducted to determine RAP-219 Long- term safety and open-label antiseizure activity in patients with Refractory Focal Epilepsy.

This is a multi-center, open-label study to evaluate the long-term safety, tolerability, pharmacokinetics, pharmacodynamics and antiseizure activity of RAP-219 in adult participants with refractory focal seizures

Inclusion Criteria:

• Completion of the associated parent study (RAP-219-FOS-201) treatment period with acceptable tolerability, per Investigator.
• Diagnosis of refractory focal epilepsy
• Stable RNS(c) system settings
• A demonstrated history of compliance with RNS(c) system data interrogation and upload
• Good overall health other than focal epilepsy, per Investigator.
• BMI ≥ 18 kg/m^2 and ≤ 45 kg/m^2
• Willing and able to adhere to all aspects of the protocol.

Exclusion Criteria:

• Known of hypersensitivity to RAP-219
• Any clinically unstable or serious medical, neurological (other than epilepsy), psychological, or behavioral problem; laboratory or ECG finding that would increase participant risk or should otherwise exclude the patient from participation, as assessed by Investigator
• Pregnancy, lactation, or individuals of reproductive potential who do not agree to simultaneously use two effective birth-control methods