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

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

  • Focal Onset Seizures

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

University of Texas Health Science Center, Houston
Houston, Texas 77030

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 RNS® system.