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

Completed · Phase 2

Conditions studied: Focal Onset Seizures

In brief

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.

Key facts

Study ID

NCT06377930

Run by

Rapport Therapeutics Inc.

People needed

30

Starts

2024-10-10

Expected to finish

2025-09-26

Last updated by the study team

2026-02-05

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Yale University — New Haven, Connecticut, United States
• Consultants in Epilepsy and Neurology, PLLC — Boise, Idaho, United States
• IU Health Neuroscience Center, Goodman Hall — Indianapolis, Indiana, United States
• The University of Kansas Medical Center Epilepsy Clinic — Kansas City, Kansas, United States
• Mayo Clinic — Rochester, Minnesota, United States
• NYU Langone Comprehensive Epilepsy Center — New York, New York, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• University of Pennsylvania - Department of Neurology — Philadelphia, Pennsylvania, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Baylor College of Medicine — Houston, Texas, United States
• University of Texas Health Science Center, Houston — Houston, Texas, United States

Full record on ClinicalTrials.gov

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