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
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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
Clareo Health | A Long-term Study of the Safety and Effectiveness of RAP-219 in Adults With Focal Onset Seizures
