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
Alabama
Clinic for Neurology
RECRUITING
Huntsville
Arkansas
Pillar Clinical Research
RECRUITING
Bentonville
Colorado
Colorado Springs Neurological Associates
RECRUITING
Colorado Springs
Florida
K2 Medical Research
RECRUITING
Maitland
Serenity Research Center, LLC
RECRUITING
Miami
Illinois
Re:Cognition Health-Chicago
RECRUITING
Chicago
North Carolina
Velocity Clinical Research
RECRUITING
Raleigh
New York
Lenox Hill Hospital
RECRUITING
New York
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Texas
Baylor College of Medicine
RECRUITING
Houston
University of Texas Health Science Center in Houston
RECRUITING
Houston
Contact Information
Primary
Rapport Medical
RAP-219-FOS@rapportrx.com
857 323 9048
Time Frame
Start Date: 2026-09
Estimated Completion Date: 2029-09
Participants
Target number of participants: 312
Treatments
Experimental: Active Arm- Medium Dose
RAP-219 daily tablets administered orally
Experimental: Active Arm-Low Dose
RAP-219 daily tablets administered orally
Placebo_comparator: Placebo
Inert comparator matching the active treatment
Sponsors
Leads: Rapport Therapeutics Inc.