NCT07219407 A Long-term Study of the Safety and Effectiveness of RAP-219 in Adults With Focal Onset Seizures
| NCT ID | NCT07219407 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Rapport Therapeutics Inc. |
| Condition | Focal Epilepsy |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-12-15 |
| Primary Completion | 2028-02-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2025-12-15 with a primary completion date of 2028-02-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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-label antiseizure activity in patients with Refractory Focal Epilepsy.
Eligibility 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
Contact & Investigator
Imran Quraishi, MD
PRINCIPAL INVESTIGATOR
Yale University
Frequently Asked Questions
Who can join the NCT07219407 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Focal Epilepsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07219407 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07219407 currently recruiting?
Yes, NCT07219407 is actively recruiting participants. Contact the research team at dmoreno@rapportrx.com for enrollment information.
Where is the NCT07219407 trial being conducted?
This trial is being conducted at Boise, United States, Rochester, United States, New York, United States, Cleveland, United States and 3 additional locations.
Who is sponsoring the NCT07219407 clinical trial?
NCT07219407 is sponsored by Rapport Therapeutics Inc.. The principal investigator is Imran Quraishi, MD at Yale University. The trial plans to enroll 30 participants.
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