Vanderbilt Clinical Trials

A Long-term Study of the Safety and Effectiveness of RAP-219 in Adults With Focal Onset Seizures

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 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
Focal Onset Seizure

Eligibility

Eligible Ages: Between 18 Years and 70 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

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

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

Arm Groups

Arm	Description	Assigned Intervention
Experimental RAP-219		Drug: 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.

Recruiting Locations

Vanderbilt University Medical Center
Nashville 4644585, Tennessee 4662168 37232

More Details

Status: Recruiting
Sponsor: Rapport Therapeutics Inc.

Study Contact

Daniela Moreno
(857) 323-9048
dmoreno@rapportrx.com

Detailed Description

This is a multi-center, open-label study to evaluate the long-term safety, tolerability, pharmacokinetics, pharmacodynamics and antiseizure activity of RAP-219 in adult participants with refractory focal seizures

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.