Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Start Date
6/5/2026
Completion Date
9/1/2029
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.
Detailed Description
Approximately 333 subjects will be randomized into one of two active treatment groups or placebo in a 1:1:1 randomization ratio (High Dosage, Medium Dosage and Placebo). After completing the Double-blind Treatment Period, participants will either transition into the RAP-219-FOS-901 long-term safety (open-label extension) study or enter the 8-week post-treatment Follow-up Period of this study.
Eligibility Criteria
Age Range: 18 years to 75 years
Interventions
RAP-219
RAP-219
Placebo
Conditions
Locations
Amicis Research Center
Palmdale, California 91324
United States
Indiana University Health Fort Wayne Neurology
Fort Wayne, Indiana 46804
United States
Mid-Atlantic Epilepsy and Sleep Center
Bethesda, Maryland 20817
United States
Northeast Regional Epilepsy Group
Hackensack, New Jersey 07601
United States
Neurological Associates
Richmond, Virginia 23236
United States