drugset / Trial / NCT04072835
Safety Study of Etripamil Nasal Spray for Patients With Paroxysmal Supraventricular Tachycardia. NODE-303
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
Publications
- Dorian P, Alings M, Coutu B, Ip JE, Martinez FA, Piccini JP, Stambler BS, Sheikh M, Shardonofsky S, Bharucha DB, Camm AJ. Self-Administered Etripamil Nasal Spray Slows Ventricular Rate in Patients With Atrial Fibrillation: A Post Hoc Analysis of the NODE-303 Study. J Cardiovasc Electrophysiol. 2026 Apr;37(4):859-863. doi: 10.1111/jce.70287. Epub 2026 Feb 10.
- Ip JE, Coutu B, Ip JH, Noseworthy PA, Parody ML, Rafii F, Sears SF, Singh N, Stambler BS, Tahirkheli NK, Agudelo-Uribe J, Hu D, Shardonofsky S, Sheikh MB, Holz A, Bharucha DB, Camm AJ. Etripamil Nasal Spray for Recurrent Paroxysmal Supraventricular Tachycardia Conversion: Results From the NODE-303 Open-Label Study. J Cardiovasc Electrophysiol. 2025 Nov;36(11):2990-3003. doi: 10.1111/jce.70086. Epub 2025 Sep 11.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Etripamil | Small molecule | 70 mg | Intranasal |