Status:
NOT_YET_RECRUITING
A Long-term Study of the Safety and Effectiveness of RAP-219 in Adults With Focal Onset Seizures
Lead Sponsor:
Rapport Therapeutics Inc.
Conditions:
Focal Epilepsy
Epilepsy
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
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-l...
Detailed Description
This is a multi-center, open-label study to evaluate the long-term safety, tolerability, pharmacokinetics, pharmacodynamics and antiseizure activity of RAP-219 in adult participants with refractory fo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 3 2028
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07219407
Start Date
November 3 2025
End Date
February 3 2028
Last Update
October 21 2025
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