A Long-term Study of the Safety and Effectiveness of RAP-219 in Adults With Focal Onset Seizures
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorRapport Therapeutics Inc.
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- RAP-219
Treatment groups
30 Participants
are divided into 1 treatment groupLocations
7Idaho
Consultants in Epilepsy and Neurology, PLLC83702, Boise United States
Minnesota
Mayo Clinic55905, Rochester United States
New York
NYU Langone Comprehensive Epilepsy Center10016, New York United States
Ohio
Cleveland Clinic Foundation44195, Cleveland United States
Sponsors and collaborators
Rapport Therapeutics Inc.
Lead sponsor
Source ClinicalTrials.gov