Phase 3 Study of RAP-219 to Evaluate Safety and Effectiveness for Adults With Focal Seizures

What this Trial Is About

Researchers are evaluating an investigational drug called RAP-219 in adults with focal seizures. The study aims to determine whether RAP-219 is safe and effective in reducing the frequency of focal seizures. This clinical trial is a Phase 3, randomized, double-blind, placebo-controlled study involving adult participants aged 18 to 75 years with focal epilepsy lasting at least 24 months. Participants are randomly assigned to one of three groups receiving either a high dose or medium dose of RAP-219 tablets or a matching placebo, all taken orally once daily. Following the 14-week double-blind treatment period, participants may join an open-label extension study to assess long-term safety or enter an 8-week post-treatment follow-up period. During the study, participants will keep daily seizure records using an electronic diary and undergo brain imaging and EEG assessments consistent with focal epilepsy diagnosis. Researchers will measure the median percent change in seizure frequency from baseline to the end of treatment, along with responder rates and seizure-free intervals. Safety and treatment effects are monitored throughout, with total participation lasting through treatment and follow-up periods.

Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1