ACTIVE_NOT_RECRUITING

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

Conditions

Focal Onset Seizures Epilepsy RNS long episode FOS Refractory focal epilepsy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-10-10

Study Completion:2025-09-22

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06377930

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.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Principal Investigator

Jaqueline A French, MD

PRINCIPAL_INVESTIGATOR

NYU Langone Comprehensive Epilepsy Center

Study Locations (Sites)

Yale University

New Haven, Connecticut, 06519

United States

Consultants in Epilepsy and Neurology, PLLC

Boise, Idaho, 83702

United States

IU Health Neuroscience Center, Goodman Hall

Indianapolis, Indiana, 46202

United States

The University of Kansas Medical Center Epilepsy Clinic

Kansas City, Kansas, 66160

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

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107

United States

Vanderbilt University Medical Center

Nashville, Tennessee, 37232

United States

Baylor College of Medicine

Houston, Texas, 770300

United States

University of Texas Health Science Center, Houston

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Rapport Therapeutics Inc.

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-10

Study Completion Date2025-09-22

Study Record Updates

Study Start Date2024-10-10

Study Completion Date2025-09-22

Terms related to this study

Keywords Provided by Researchers

Epilepsy
RNS
long episode
FOS
Refractory focal epilepsy

Additional Relevant MeSH Terms

Focal Onset Seizures