Actively Recruiting
A Phase 3 Randomized Study of RAP-219 to Evaluate Safety and Effectiveness in Adults With Focal Seizures
Led by Rapport Therapeutics Inc. · Updated on 2026-05-29
333
Participants Needed
2
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the investigational drug RAP-219 in adults with focal seizures to determine its safety and effectiveness in reducing the frequency of these seizures. This Phase 3 clinical trial involves participants aged 18 to 75 who have a diagnosis of focal epilepsy and are currently using one to three antiseizure medications. The study aims to provide important information about RAP-219's potential to help manage focal seizures. Participants will be randomly assigned to one of three groups: a high-dose RAP-219 group, a medium-dose RAP-219 group, or a placebo group. Each participant will take daily oral tablets according to their assigned group during the 14-week double-blind treatment period. After this phase, participants may either join a long-term open-label extension study to continue receiving RAP-219 or enter an 8-week follow-up period without treatment. During the study, participants will keep daily records of their focal seizures using an electronic diary. Researchers will assess changes in seizure frequency by comparing baseline data to the end of the treatment period. They will also evaluate responder rates and the longest seizure-free intervals. Safety and other health assessments will be conducted throughout the trial, which is expected to last until September 2029.
CONDITIONS
Brief Title
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Body mass index (BMI) between 18 and 45 kg/m2
- Diagnosis of focal epilepsy for at least 24 months before the first visit
- Brain MRI or CT scan and EEG done within 10 years before the first visit showing focal epilepsy
- Currently using 1 to 3 maintenance antiseizure medications (not including rescue or PRN medications)
- Ability to keep accurate daily records of focal seizures using an electronic diary
You will not qualify if you...
- Known allergy to RAP-219 or previous use of RAP-219
- Unstable or uncontrolled serious medical, neurological (other than focal epilepsy), or psychiatric conditions
- Planned surgery during the study period
- History of generalized epilepsy
- Having only focal aware nonmotor seizures as the sole seizure type
- History of psychogenic nonepileptic seizures (PNES)
- Status epilepticus or seizure clusters within 12 months prior to the first visit
- Epilepsy surgery within 12 months prior to the first visit
- Participation in another investigational drug study within 12 weeks or 5 half-lives of that drug
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 14 weeks
Participants receive daily oral tablets of RAP-219 at either high dose, medium dose, or placebo during the double-blind treatment period.
Regular visits during the 14-week treatment period
Duration - 8 weeks
Participants enter an 8-week post-treatment follow-up period after completing the double-blind treatment.
Visits during the 8-week follow-up period
Trial Site Locations
Total: 2 locations
1
Amicis Research Center
Palmdale, California, United States, 91324
Actively Recruiting
2
Indiana University Health Fort Wayne Neurology
Fort Wayne, Indiana, United States, 46804
Actively Recruiting
Research Team
R
Rapport Medical
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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