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 (3) 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
Indiana
Indiana University Health Fort Wayne Neurology
RECRUITING
Fort Wayne
Maryland
Mid-Atlantic Epilepsy and Sleep Center
RECRUITING
Bethesda
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.