Study Evaluating the Safety and Efficacy of RAP-219 in Adult Participants With Refractory Focal Epilepsy

Last updated: June 17, 2025
Sponsor: Rapport Therapeutics Inc.
Overall Status: Active - Not Recruiting

Phase

2

Condition

Epilepsy

Treatment

RAP-219

Clinical Study ID

NCT06377930
RAP-219-FOS-201
  • Ages 18-65
  • All Genders

Study 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 if RAP-219 works and is safe in patients with Refractory Focal Epilepsy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Medically refractory focal epilepsy with an implanted responsive neurostimulatordevice placed correctly in a seizure onset zone that meet several device-relatedcriteria and demonstrated history of compliance with interrogation of the RNS deviceand upload of data

  • If currently treated with antiseizure medications, up to a maximum of 4 concomitantmediations 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 uploadof data before screening

Exclusion

Exclusion Criteria:

  • Participants with generalized onset seizures in the past 10 years

  • History of status epilepticus while on antiseizure medications within 2 years ofscreening

  • Individuals of reproductive potential who do not agree to simultaneously use twoeffective birth-control methods

  • Participants who have had epilepsy surgery within the last 12 months beforescreening

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: RAP-219
Phase: 2
Study Start date:
October 10, 2024
Estimated Completion Date:
September 22, 2025

Study Description

This is a Phase 2A, proof-of-concept, multi-center, open-label study designed to evaluate the efficacy, safety, tolerability, and PK/PD relationship of RAP-219 in adult participants with refractory focal epilepsy. The activity of RAP-219 will be assessed in approximately 20 participants treated with the RNS® system.

Connect with a study center

  • Yale University

    New Haven, Connecticut 06519
    United States

    Site Not Available

  • Emory Brain Health Center

    Atlanta, Georgia 30329
    United States

    Site Not Available

  • Consultants in Epilepsy and Neurology, PLLC

    Boise, Idaho 83702
    United States

    Site Not Available

  • IU Health Neuroscience Center, Goodman Hall

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • The University of Kansas Medical Center Epilepsy Clinic

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Corewell Health Research Institute

    Grand Rapids, Michigan 49503
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • University of Texas Health Science Center, Houston Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • NYU Langone Comprehensive Epilepsy Center

    New York, New York 10016
    United States

    Site Not Available

  • Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Thomas Jefferson University

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • University of Pennsylvania - Department of Neurology

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Baylor College of Medicine

    Houston, Texas 770300
    United States

    Site Not Available

  • University of Texas Health Science Center, Houston

    Houston, Texas 77030
    United States

    Site Not Available

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