A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Status: Recruiting
Location: See all (11) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This is a clinical research study for an investigational drug called RAP-219 in adult participants with focal seizures. This study is being conducted to determine if RAP-219 is safe and effective in reducing focal seizure frequency.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Age 18 - 75
• BMI 18-45 kg/m2
• Diagnosis of focal epilepsy for ≥24 months prior to Visit 1
• Report from at least 1 brain MRI or CT scan and 1 EEG study, each completed within 10 years prior to Visit 1, consistent with focal epilepsy diagnosis
• Concomitant use of between 1 and 3, inclusive, antiseizure medication(s) ASM(s) as maintenance, not including rescue or pro re nata (PRN) ASMs
• Ability to keep accurate daily focal seizure records using an e-diary
Locations
United States
California
Amicis Research Center
RECRUITING
Palmdale
Florida
Panhandle Research and Medical Clinic, LLC
RECRUITING
Gulf Breeze
Georgia
Emory Brain Health Center
RECRUITING
Atlanta
Idaho
Consultants in Epilepsy & Neurology, PLLC
RECRUITING
Boise
Indiana
Indiana University Health Fort Wayne Neurology
RECRUITING
Fort Wayne
Maryland
Mid-Atlantic Epilepsy and Sleep Center
RECRUITING
Bethesda
North Carolina
Asheville Neurology Specialists
RECRUITING
Asheville
New Jersey
Northeast Regional Epilepsy Group
RECRUITING
Hackensack
Ohio
Cleveland Clinic
RECRUITING
Cleveland
Pennsylvania
Thomas Jefferson University
RECRUITING
Philadelphia
Virginia
Neurological Associates
RECRUITING
Richmond
Contact Information
Primary
Rapport Medical
RAP-219-FOS@rapportrx.com
857 323 9048
Time Frame
Start Date: 2026-06-05
Estimated Completion Date: 2029-09
Participants
Target number of participants: 333
Treatments
Experimental: Active Arm- High Dose
RAP-219 daily tablets administered orally
Experimental: Active Arm- Medium Dose
RAP-219 daily tablets administered orally
Placebo_comparator: Placebo
Inert comparator matching the active treatment
Sponsors
Leads: Rapport Therapeutics Inc.