An Open-label, Long-term Study Evaluating RAP-219 in Adult Participants With Refractory Onset Seizures
Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• 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.
Locations
United States
Idaho
Consultants in Epilepsy and Neurology, PLLC
RECRUITING
Boise
Minnesota
Mayo Clinic
RECRUITING
Rochester
New York
NYU Langone Comprehensive Epilepsy Center
RECRUITING
New York
Ohio
Cleveland Clinic Foundation
RECRUITING
Cleveland
Pennsylvania
University of Pennsylvania - Department of Neurology
RECRUITING
Philadelphia
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Texas
Baylor College of Medicine
RECRUITING
Houston
Contact Information
Primary
Daniela Moreno
dmoreno@rapportrx.com
(857) 323-9048
Backup
Beth Bowers
bbowers@rapportrx.com
(857) 323-9048
Time Frame
Start Date: 2025-12-15
Estimated Completion Date: 2028-02-03
Participants
Target number of participants: 30
Treatments
Experimental: RAP-219
Sponsors
Leads: Rapport Therapeutics Inc.