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NCT07219407PHASE2Recruiting

A Long-term Study of the Safety and Effectiveness of RAP-219 in Adults With Focal Onset Seizures

Rapport Therapeutics Inc.

Start Date

12/15/2025

Completion Date

2/3/2028

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.

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 focal seizures

Eligibility Criteria

Age Range: 18 years to 70 years

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

Interventions

DRUG

RAP-219

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Conditions

Focal EpilepsyEpilepsyRefractory Focal EpilepsySeizureFocal SeizureFocal Onset Seizure

Locations

Consultants in Epilepsy and Neurology, PLLC

Boise, Idaho 83702

United States

Mayo Clinic

Rochester, Minnesota 55905

United States

NYU Langone Comprehensive Epilepsy Center

New York, New York 10016

United States

Cleveland Clinic Foundation

Cleveland, Ohio 44195

United States

University of Pennsylvania - Department of Neurology

Philadelphia, Pennsylvania 19104

United States

Vanderbilt University Medical Center

Nashville, Tennessee 37232

United States

Baylor College of Medicine

Houston, Texas 770300

United States