Recruiting
Phase 2

RAP-219

Sponsor:

Rapport Therapeutics Inc.

Code:

NCT07219407

Conditions

Focal Epilepsy

Epilepsy

Refractory Focal Epilepsy

Seizure

Focal Seizure

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

RAP-219

Study Details

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 RAP-219 Long- term safety and open-label antiseizure activity in patients with Refractory Focal Epilepsy.

Conditions

Focal Epilepsy

Epilepsy

Refractory Focal Epilepsy

Seizure

Focal Seizure

Study ID

NCT07219407

Start date

Dec 15, 2025

Status verified date

Jan, 2026

Completion date

Feb 3, 2028

Anticipated

Primary completion date

Feb 3, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 ≥ 18 kg/m\^2 and ≤ 45 kg/m\^2
  • Willing and able to adhere to all aspects of the protocol.

Exclusion Criteria:

  • Known of 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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: RAP-219

Interventions

RAP-219

Participants will receive one RAP-219 0.125 mg capsule daily for 3 days followed by one 0.25mg tablet RAP-219 daily for 28 days, then one 0.75mg tablet daily for the remainder of the treatment period.

Primary outcome measure

  • Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: From the start of RAP-219 treatment through 8 weeks after last dose, up to Week 112 ]

Central Contacts and Locations

Central contacts

Daniela Moreno

(857) 323-9048dmoreno@rapportrx.com

Beth Bowers

(857) 323-9048bbowers@rapportrx.com

Locations

Consultants in Epilepsy and Neurology, PLLC

Recruiting

Boise, Idaho, United States, 83702

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

NYU Langone Comprehensive Epilepsy Center

Recruiting

New York, New York, United States, 10016

Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

University of Pennsylvania - Department of Neurology

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 770300

More Information

Sponsor

Rapport Therapeutics Inc.

Last update posted

Jan 23, 2026

Last verified

Jan, 2026

Keywords

  • Focal Seizures
  • Epilepsy
  • RNS
  • Long episode

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Rapport Therapeutics Inc. on 2026-01-23.