An Open-label, Long-term Study Evaluating RAP-219 in Adult Participants With Refractory Onset Seizures
Rapport Therapeutics Inc.
Summary
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.
Description
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
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugRAP-219
Participants will receive one RAP-219 0.125 mg capsule daily for 3 days followed by one 0.25mg tablet RAP-219 daily for 28 days, then one 0.75mg tablet daily for the remainder of the treatment period.
Locations (7)
- Consultants in Epilepsy and Neurology, PLLCBoise, Idaho
- Mayo ClinicRochester, Minnesota
- NYU Langone Comprehensive Epilepsy CenterNew York, New York
- Cleveland Clinic FoundationCleveland, Ohio
- University of Pennsylvania - Department of NeurologyPhiladelphia, Pennsylvania
- Vanderbilt University Medical CenterNashville, Tennessee