drugset / Trial / NCT04072835

Safety Study of Etripamil Nasal Spray for Patients With Paroxysmal Supraventricular Tachycardia. NODE-303

NCT04072835 ↗

Non-randomizedSingle-groupOpen-labelTreatment

Summary

NODE-303 was a multi-center, open label study to evaluate the safety of etripamil NS in participants with Paroxysmal Supraventricular Tachycardia (PSVT). Participants were provided with an ambulatory Cardiac Monitoring System (CMS) to help document PSVT episodes. The CMS was self-applied by the participant, when they felt the onset of PSVT symptoms. Participants self-administered etripamil NS if vagal maneuver was ineffective. After an episode of PSVT where study drug was administered, the participant returned to the investigative site and had the option to continue in NODE-303 and manage up to three subsequent episodes of PSVT with etripamil NS for a maximum of four episodes.

Timeline

Start
2019-09-23
Primary completion
2023-01-26
Completion
2023-01-26

Drugs

EvaluationDrugModalityDoseRoute
Subject Etripamil Small molecule 70 mg Intranasal