A Long-term Study of the Safety and Effectiveness of RAP-219 in Adults With Focal Onset Seizures
Recruiting · NCT07219407 · Interventional (participants receive a specific treatment) · Lead sponsor: Rapport Therapeutics Inc.
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years to 70 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
7 locations listed across 7 US states.
- Consultants in Epilepsy and Neurology, PLLC - Boise, Idaho, United States
- Mayo Clinic - Rochester, Minnesota, United States
- NYU Langone Comprehensive Epilepsy Center - New York, New York, United States
- Cleveland Clinic Foundation - Cleveland, Ohio, United States
- University of Pennsylvania - Department of Neurology - Philadelphia, Pennsylvania, United States
- Vanderbilt University Medical Center - Nashville, Tennessee, United States
- Baylor College of Medicine - Houston, Texas, United States