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

Description

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.

Conditions

Focal Onset Seizures

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Study Overview

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Study Details

Study overview

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.

A Phase 2A, Multicenter, Open-label Study Evaluating the Safety and Efficacy of RAP-219 in Adult Participants With Refractory Focal Epilepsy

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

Condition
Focal Onset Seizures
Intervention / Treatment

-

Contacts and Locations

New Haven

Yale University, New Haven, Connecticut, United States, 06519

Boise

Consultants in Epilepsy and Neurology, PLLC, Boise, Idaho, United States, 83702

Indianapolis

IU Health Neuroscience Center, Goodman Hall, Indianapolis, Indiana, United States, 46202

Kansas City

The University of Kansas Medical Center Epilepsy Clinic, Kansas City, Kansas, United States, 66160

Rochester

Mayo Clinic, Rochester, Minnesota, United States, 55905

New York

NYU Langone Comprehensive Epilepsy Center, New York, New York, United States, 10016

Cleveland

Cleveland Clinic Foundation, Cleveland, Ohio, United States, 44195

Philadelphia

University of Pennsylvania - Department of Neurology, Philadelphia, Pennsylvania, United States, 19104

Nashville

Vanderbilt University Medical Center, Nashville, Tennessee, United States, 37232

Houston

University of Texas Health Science Center, Houston, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Medically refractory focal epilepsy with an implanted responsive neurostimulator device placed correctly in a seizure onset zone that meet several device-related criteria and demonstrated history of compliance with interrogation of the RNS device and upload of data
  • * If currently treated with antiseizure medications, up to a maximum of 4 concomitant mediations 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 upload of data before screening
  • * Participants with generalized onset seizures in the past 10 years
  • * History of status epilepticus while on antiseizure medications within 2 years of screening
  • * Individuals of reproductive potential who do not agree to simultaneously use two effective birth-control methods
  • * Participants who have had epilepsy surgery within the last 12 months before screening

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Rapport Therapeutics Inc.,

Jaqueline A French, MD, PRINCIPAL_INVESTIGATOR, NYU Langone Comprehensive Epilepsy Center

Study Record Dates

2025-06-01