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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
333
Amicis Research Center
Palmdale, California, United States
RECRUITINGIndiana University Health Fort Wayne Neurology
Fort Wayne, Indiana, United States
RECRUITINGMedian Percent Change in Seizure Frequency
Median percent change in seizure frequency and ≥ 50% seizure frequency reduction responder rates:
Time frame: End of double-blind treatment period (end of week 14) vs Baseline
≥50% seizure frequency reduction responder rates
Proportion of participants with at least 50% reduction from baseline in seizure frequency after treatment with RAP-219 compared with placebo
Time frame: End of double-blind treatment period (end of week 14) vs Baseline.
Longest Seizure Free Interval
To evaluate the longest seizure-free interval after treatment with RAP-219 compared with placebo
Time frame: Across the entire 14-week double-blind treatment period
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