NCT07219407

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

An Open-label, Long-term Study Evaluating RAP-219 in Adult Participants With Refractory Onset Seizures

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Rapport Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

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

Conditions

• Focal Epilepsy
• Epilepsy
• Refractory Focal Epilepsy
• Seizure
• Focal Seizure
• Focal Onset Seizure

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-12-15
• Primary completion: 2028-02-03
• Completion: 2028-02-03
• First posted: 2025-10-21
• Last updated: 2026-01-23

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study