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

NCT06377930 | Completed Phase 2 FDA Drug

• 1 other identifier: RAP-219-FOS-201
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 12

Brief Summary

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

Keywords

Epilepsy; RNS; long episode; FOS; Refractory focal epilepsy

Outcome Measures

Primary Outcomes (1)

• Change in long episode frequency during the treatment period compared to pre-treatment baseline: Responder proportion, Percent Change Percent change

  Change in long episode frequency per 28-day period during the treatment period compared to baseline

  Screening until 5 months after enrollment

Secondary Outcomes (12)

• Change in focal clinical seizure frequency during the treatment period compared to pre-treatment baseline: Percent Change, Responder proportion

  Screening until 5 months after enrollment

• Change in frequency of estimated electrographic seizures based on RNS® system data during the treatment period compared to pre-treatment baseline

  Screening until 5 months after enrollment

• Change in RNS® system long episode-free days during the treatment period compared to pre-treatment baseline: Count, Longest continuous interval, Time until pre-treatment count

  Screening until 5 months after enrollment

• Change in focal clinical seizure-free days during the treatment period compared to pre-treatment baseline: Count, Longest continuous interval, Time until pre-treatment count

  Screening until 5 months after enrollment

• Change in RNS® system electrographic biomarkers other than long episodes during the treatment period compared to pre-treatment baseline

  Dosing until 5 months after dosing

Study Arms (1)

RAP-219

EXPERIMENTAL

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.

Drug: RAP-219

Interventions

RAP-219 DRUG

RAP-219 oral tablet

RAP-219

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Rapport Therapeutics Inc.: lead

Study Sites (12)

Yale University

New Haven, Connecticut, 06519, United States

Location

Consultants in Epilepsy and Neurology, PLLC

Boise, Idaho, 83702, United States

Location

IU Health Neuroscience Center, Goodman Hall

Indianapolis, Indiana, 46202, United States

Location

The University of Kansas Medical Center Epilepsy Clinic

Kansas City, Kansas, 66160, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

NYU Langone Comprehensive Epilepsy Center

New York, New York, 10016, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

University of Pennsylvania - Department of Neurology

Philadelphia, Pennsylvania, 19104, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Baylor College of Medicine

Houston, Texas, 770300, United States

Location

University of Texas Health Science Center, Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Seizures; Epilepsy; Epilepsies, Partial

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases

Study Officials

• Jaqueline A French, MD

  NYU Langone Comprehensive Epilepsy Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: April 22, 2024
• Study Start: October 10, 2024
• Primary Completion: September 26, 2025
• Study Completion: September 26, 2025
• Last Updated: February 5, 2026

Record last verified: 2026-02

Locations

US (12)