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

Rapport Therapeutics Inc.

Status and phase

Enrolling

Phase 2

Conditions

Seizure

Refractory Focal Epilepsy

Epilepsy

Focal Epilepsy

Focal Onset Seizure

Focal Seizure

Treatments

Drug: RAP-219

Study type

Interventional

Funder types

Industry

Identifiers

NCT07219407

RAP-219-FOS-901

Details and patient eligibility

About

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.

Full 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

Enrollment

30 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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