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

NCT ID: NCT06377930

Last Updated: 2026-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-10

Study Completion Date

2025-09-26

Brief Summary

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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.

Detailed Description

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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 30 participants treated with the RNSĀ® system.

Conditions

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Focal Onset Seizures

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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RAP-219

Participants will receive 0.75 mg RAP-219 daily for 5 days followed by 1.25 mg RAP-219 daily for the remainder of the 8-week treatment period.

Group Type EXPERIMENTAL

RAP-219

Intervention Type DRUG

RAP-219 oral tablet

Interventions

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RAP-219

RAP-219 oral tablet

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rapport Therapeutics Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jaqueline A French, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Comprehensive Epilepsy Center

Locations

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Yale University

New Haven, Connecticut, United States

Site Status

Consultants in Epilepsy and Neurology, PLLC

Boise, Idaho, United States

Site Status

IU Health Neuroscience Center, Goodman Hall

Indianapolis, Indiana, United States

Site Status

The University of Kansas Medical Center Epilepsy Clinic

Kansas City, Kansas, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

NYU Langone Comprehensive Epilepsy Center

New York, New York, United States

Site Status

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

University of Pennsylvania - Department of Neurology

Philadelphia, Pennsylvania, United States

Site Status

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Site Status

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Baylor College of Medicine

Houston, Texas, United States

Site Status

University of Texas Health Science Center, Houston

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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RAP-219-FOS-201

Identifier Type: -

Identifier Source: org_study_id

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