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

ArmDescriptionAssigned 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

For general questions about clinical trials, contact Research Support Services at (615) 322-7343 or research.support.services@vumc.org