What is RAP-219 studying for refractory focal epilepsy?

RAP-219 is being studied to understand its long-term safety and antiseizure effects in adults with refractory focal epilepsy, a condition where seizures are hard to control. The research aims to see how well RAP-219 works over time and how well patients tolerate it. This study is sponsored by Rapport Therapeutics Inc.

Who may be eligible for this refractory focal epilepsy clinical trial?

Adults aged 18 to 70 years with a diagnosis of refractory focal epilepsy who have completed a related RAP-219 parent study treatment period may be eligible. Participants must have stable RNS system settings and generally good health aside from epilepsy. Please review eligibility criteria for more details.

Is there any cost to participate in this refractory focal epilepsy clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel expenses and other costs related to participation may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 2

Age: 18Years - 70Years

All Genders

ID07219407

Long-term Study of RAP-219 Safety and Effectiveness in Adults with Refractory Focal Seizures

Led by Rapport Therapeutics Inc. · Updated on 2026-01-23

Participants Needed

Research Sites

N/A

Total Duration

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

Age: 18Years - 70Years

All Genders

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

Research Team

Daniela Moreno

Beth Bowers

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here