Long-term RAP-219 treatment for adults with focal onset seizures
An Open-label, Long-term Study Evaluating RAP-219 in Adult Participants With Refractory Onset Seizures
This trial will try RAP-219, an investigational anti-seizure medication, in adults with refractory focal seizures to see if it is safe long-term and helps reduce seizures.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Rapport Therapeutics Inc. Industry-sponsored |
| Locations | 7 sites (Boise, Idaho and 6 other locations) |
| Trial ID | NCT07219407 on ClinicalTrials.gov |
What this trial studies
This is a multi-center, open-label, long-term extension enrolling adults with refractory focal seizures who completed the parent RAP-219-FOS-201 study. Participants will receive RAP-219 and undergo regular safety, tolerability, pharmacokinetic, and pharmacodynamic monitoring, along with tracking of seizure activity. Stable RNS system settings and regular device data uploads are required to document seizure outcomes. The study focuses on gathering extended safety data and observing any sustained antiseizure effects in a real-world, monitored setting.
Who should consider this trial
Good fit: Ideal candidates are adults with refractory focal epilepsy who completed the parent RAP-219-FOS-201 treatment period, have stable RNS system settings, and a history of compliance with device data uploads.
Not a fit: Patients who are pregnant or lactating, have hypersensitivity to RAP-219, have unstable medical/neurological conditions, or did not complete the parent study are unlikely to qualify or receive benefit from this protocol.
Why it matters
Potential benefit: If successful, RAP-219 could offer a tolerable long-term treatment option that reduces seizure frequency for some adults with refractory focal epilepsy.
How similar studies have performed: Other antiseizure medications and open-label extensions have sometimes shown sustained seizure reductions, but RAP-219 remains investigational and its long-term benefits are not yet proven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Completion of the associated parent study (RAP-219-FOS-201) treatment period with acceptable tolerability, per Investigator. * Diagnosis of refractory focal epilepsy * Stable RNS(c) system settings * A demonstrated history of compliance with RNS(c) system data interrogation and upload * Good overall health other than focal epilepsy, per Investigator. * BMI ≥ 18 kg/m\^2 and ≤ 45 kg/m\^2 * Willing and able to adhere to all aspects of the protocol. Exclusion Criteria: * Known of hypersensitivity to RAP-219 * Any clinically unstable or serious medical, neurological (other than epilepsy), psychological, or behavioral problem; laboratory or ECG finding that would increase participant risk or should otherwise exclude the patient from participation, as assessed by Investigator * Pregnancy, lactation, or individuals of reproductive potential who do not agree to simultaneously use two effective birth-control methods
Where this trial is running
Boise, Idaho and 6 other locations
- Consultants in Epilepsy and Neurology, PLLC — Boise, Idaho, United States (Recruiting)
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
- NYU Langone Comprehensive Epilepsy Center — New York, New York, United States (Recruiting)
- Cleveland Clinic Foundation — Cleveland, Ohio, United States (Recruiting)
- University of Pennsylvania - Department of Neurology — Philadelphia, Pennsylvania, United States (Recruiting)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
- Baylor College of Medicine — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Imran Quraishi, MD — Yale University
- Study coordinator: Daniela Moreno
- Email: dmoreno@rapportrx.com
- Phone: (857) 323-9048
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.