Actively Recruiting
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Led by Rapport Therapeutics Inc. · Updated on 2026-06-08
312
Participants Needed
2
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating an investigational drug called RAP-219 in adults with focal seizures. The study aims to find out if RAP-219 is safe and effective at reducing how often these seizures occur. This is a Phase 3 trial including adults aged 18 to 75 years who have a diagnosis of focal epilepsy and are currently taking antiseizure medications. About 312 participants will be randomly assigned to one of three groups: a medium dose of RAP-219, a low dose of RAP-219, or a placebo. These treatments are given as daily oral tablets during a 14-week double-blind period where neither participants nor researchers know who receives which treatment. After this, participants can join a long-term open-label safety study with RAP-219 or enter an 8-week post-treatment follow-up period. Participants will keep daily seizure records using an electronic diary and attend regular visits for assessments. Researchers will measure the median percent change in seizure frequency from the start to the end of the double-blind period as the main outcome. They will also track responder rates based on seizure frequency reduction and the longest seizure-free intervals. Safety and effectiveness will be monitored throughout the study and follow-up.
CONDITIONS
Brief Title
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 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
- At least one brain MRI or CT scan and one EEG study within 10 years before the first visit, consistent with focal epilepsy
- Using between one and three antiseizure medications as maintenance treatment
- Ability to keep accurate daily seizure records using an electronic diary
You will not qualify if you...
- Known allergy or prior exposure to RAP-219
- Unstable or uncontrolled serious medical, neurological (other than focal epilepsy), or psychiatric conditions
- Expected need for surgery during the study
- History of generalized epilepsy
- Only having focal aware nonmotor seizures as the sole seizure type
- History of psychogenic nonepileptic seizures
- Status epilepticus or seizure clusters within 12 months before the first visit
- Epilepsy surgery within 12 months before the first visit
- Participation in another investigational study within 12 weeks or five half-lives of that treatment
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 medium dose, low dose, or placebo during the double-blind treatment period.
Regular visits during the 14-week treatment period
Duration - 8 weeks
After treatment ends, participants enter an 8-week post-treatment follow-up period to monitor safety and seizure outcomes.
Visits during the 8-week follow-up period
Trial Site Locations
Total: 2 locations
1
Pillar Clinical Research
Bentonville, Arkansas, United States, 72712
Actively Recruiting
2
K2 Medical Research
Maitland, Florida, United States, 32751
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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