A Long-term Study of the Safety and Effectiveness of RAP-219 in Adults With Focal Onset Seizures
Recruiting now · Phase 2
Conditions studied: Focal Epilepsy, Epilepsy, Refractory Focal Epilepsy, Seizure, Focal Seizure, Focal Onset Seizure
In brief
This is a clinical research study for an investigational drug called RAP-219 in patients with Refractory Focal Epilepsy. This study is being conducted to determine RAP-219 Long- term safety and open-label antiseizure activity in patients with Refractory Focal Epilepsy.
Key facts
- Study ID
- NCT07219407
- Run by
- Rapport Therapeutics Inc.
- People needed
- 30
- Starts
- 2025-12-15
- Expected to finish
- 2028-02-03
- Last updated by the study team
- 2026-01-23
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 it is running
- Consultants in Epilepsy and Neurology, PLLC — Boise, Idaho, United States (enrolling)
- Mayo Clinic — Rochester, Minnesota, United States (enrolling)
- NYU Langone Comprehensive Epilepsy Center — New York, New York, United States (enrolling)
- Cleveland Clinic Foundation — Cleveland, Ohio, United States (enrolling)
- University of Pennsylvania - Department of Neurology — Philadelphia, Pennsylvania, United States (enrolling)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (enrolling)
- Baylor College of Medicine — Houston, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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