Actively Recruiting
An Open-label, Long-term Study Evaluating RAP-219 in Adult Participants With Refractory Onset Seizures
Led by Rapport Therapeutics Inc. · Updated on 2026-01-23
30
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating RAP-219, an investigational drug, for adults with refractory focal epilepsy, a condition involving difficult-to-control focal seizures. This open-label, multi-center study aims to assess the long-term safety, tolerability, how the drug behaves in the body, and its antiseizure activity in adults who have not responded well to previous treatments. Participants will receive RAP-219 starting with one 0.125 mg capsule daily for 3 days, then one 0.25 mg tablet daily for 28 days, followed by one 0.75 mg tablet daily for the rest of the treatment period. The study is open-label, meaning all participants know they are receiving RAP-219, and the treatment period may last up to 112 weeks with ongoing monitoring. During the study, participants will be regularly assessed for treatment-related side effects and seizure frequency compared to their baseline before treatment. Researchers will monitor seizure-free days, longest seizure-free intervals, and other seizure-related measures using clinical assessments and RNS system data. Safety will be tracked through adverse event reporting up to 8 weeks after the last dose. The total participation duration can be up to about 2 years, with ongoing evaluations throughout.
CONDITIONS
Brief Title
A Long-term Study of the Safety and Effectiveness of RAP-219 in Adults With Focal Onset Seizures
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Completed the treatment period of the related RAP-219 parent study with acceptable tolerability as assessed by the investigator
- Diagnosed with refractory focal epilepsy
- Stable Responsive Neurostimulation (RNS) system settings
- History of compliance with RNS system data interrogation and upload
- Generally good health aside from focal epilepsy, as determined by the investigator
- Body mass index (BMI) between 18 and 45 kg/m^2
- Willing and able to follow all aspects of the study protocol
You will not qualify if you...
- Known allergy or hypersensitivity to RAP-219
- Any unstable or serious medical, neurological (other than epilepsy), psychological, or behavioral condition that increases risk or disqualifies participation, as assessed by the investigator
- Pregnancy or breastfeeding, or unwillingness to use two effective birth control methods if of reproductive potential
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 - Up to 112 weeks
Participants receive RAP-219 capsules and tablets daily with increasing doses over the treatment period to evaluate safety and effectiveness for refractory focal seizures.
Regular visits throughout the treatment period
Duration - 8 weeks
Participants are monitored for safety and effectiveness for 8 weeks after the last dose of RAP-219.
Multiple visits during the follow-up period
Trial Site Locations
Total: 7 locations
1
Consultants in Epilepsy and Neurology, PLLC
Boise, Idaho, United States, 83702
Actively Recruiting
2
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
3
NYU Langone Comprehensive Epilepsy Center
New York, New York, United States, 10016
Actively Recruiting
4
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
5
University of Pennsylvania - Department of Neurology
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
6
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
7
Baylor College of Medicine
Houston, Texas, United States, 770300
Actively Recruiting
Research Team
D
Daniela Moreno
B
Beth Bowers
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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