Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
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.
  • Drug: RAP-219
    RAP-219 oral tablet

Recruiting Locations

The University of Kansas Medical Center Epilepsy Clinic
Kansas City, Kansas 66160

More Details

Status
Recruiting
Sponsor
Rapport Therapeutics Inc.

Study Contact

Beth Bowers
(857) 323-9048
bbowers@rapportrx.com

Detailed Description

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 20 participants treated with the RNSĀ® system.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.