Actively Recruiting

Phase 2
Age: 18Years - 70Years
All Genders
NCT07219407

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

Led by Rapport Therapeutics Inc. · Updated on 2026-01-23

30

Participants Needed

7

Research Sites

111 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 6 18 kg/m^2 and 45 kg/m^2
  • Willing and able to adhere to all aspects of the protocol
Not Eligible

You will not qualify if you...

  • Known 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

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 7 locations

1

Consultants in Epilepsy and Neurology, PLLC

Boise, Idaho, United States, 83702

Actively Recruiting

2

Mayo Clinic

Rochester, Minnesota, United States, 55905

Actively Recruiting

3

NYU Langone Comprehensive Epilepsy Center

New York, New York, United States, 10016

Actively Recruiting

4

Cleveland Clinic Foundation

Cleveland, Ohio, United States, 44195

Actively Recruiting

5

University of Pennsylvania - Department of Neurology

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

6

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37232

Actively Recruiting

7

Baylor College of Medicine

Houston, Texas, United States, 770300

Actively Recruiting

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Research Team

D

Daniela Moreno

CONTACT

B

Beth Bowers

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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