Evaluating RAP-219 for treating refractory focal epilepsy
A Phase 2A, Multicenter, Open-label Study Evaluating the Safety and Efficacy of RAP-219 in Adult Participants With Refractory Focal Epilepsy
This study is testing a new drug called RAP-219 to see if it can help adults with hard-to-treat focal epilepsy who have a special device implanted to manage their seizures.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Rapport Therapeutics Inc. Industry-sponsored |
| Locations | 14 sites (New Haven, Connecticut and 13 other locations) |
| Trial ID | NCT06377930 on ClinicalTrials.gov |
What this trial studies
This clinical research focuses on the investigational drug RAP-219 for adults suffering from refractory focal epilepsy. It is a Phase 2A, proof-of-concept, multi-center, open-label study that aims to assess the efficacy, safety, and tolerability of RAP-219 in participants who have an implanted responsive neurostimulator device. Approximately 20 participants will be treated, and their response to the drug will be monitored to determine its effectiveness and safety profile.
Who should consider this trial
Good fit: Ideal candidates are adults with medically refractory focal epilepsy who have an implanted responsive neurostimulator device and a history of compliance with device data uploads.
Not a fit: Patients with generalized onset seizures or a history of status epilepticus while on antiseizure medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with refractory focal epilepsy who have not responded to existing treatments.
How similar studies have performed: While this approach is novel, similar studies evaluating investigational drugs for refractory epilepsy have shown promise in the past.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Medically refractory focal epilepsy with an implanted responsive neurostimulator device placed correctly in a seizure onset zone that meet several device-related criteria and demonstrated history of compliance with interrogation of the RNS device and upload of data * If currently treated with antiseizure medications, up to a maximum of 4 concomitant mediations are allowed * At least 1 clinical seizure during the 8-week retrospective eligibility period * Participants in otherwise good health as determined by the investigator * Willing and able to adhere to all aspects of the protocol * A demonstrated history of compliance with interrogation of the RNS device and upload of data before screening Exclusion Criteria: * Participants with generalized onset seizures in the past 10 years * History of status epilepticus while on antiseizure medications within 2 years of screening * Individuals of reproductive potential who do not agree to simultaneously use two effective birth-control methods * Participants who have had epilepsy surgery within the last 12 months before screening
Where this trial is running
New Haven, Connecticut and 13 other locations
- Yale University — New Haven, Connecticut, United States (Recruiting)
- Emory Brain Health Center — Atlanta, Georgia, United States (Recruiting)
- Consultants in Epilepsy and Neurology, PLLC — Boise, Idaho, United States (Recruiting)
- IU Health Neuroscience Center, Goodman Hall — Indianapolis, Indiana, United States (Recruiting)
- The University of Kansas Medical Center Epilepsy Clinic — Kansas City, Kansas, United States (Recruiting)
- Corewell Health Research Institute — Grand Rapids, Michigan, 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)
- Thomas Jefferson University — Philadelphia, Pennsylvania, United States (Recruiting)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
- Baylor College of Medicine — Houston, Texas, United States (Recruiting)
- University of Texas Health Science Center, Houston — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Jaqueline A French, MD — NYU Langone Comprehensive Epilepsy Center
- Study coordinator: Beth Bowers
- Email: bbowers@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.