Safety Study of Intranasal Etripamil for the Termination of Spontaneous Episodes of Paroxysmal Supraventricular Tachycardia (PSVT). NODE-302

Phase 3

Terminated

• Conditions: Paroxysmal Supraventricular Tachycardia
• Interventions: Drug: Etripamil NS 70 mg; Device: Aptar Pharma Nasal Spray Bidose System

• Registration Number: NCT03635996
• Lead Sponsor: Milestone Pharmaceuticals Inc.

Brief Summary

The primary objective of this study is to evaluate the safety of etripamil nasal spray (NS) 70 mg when self-administered by patients with an episode of Paroxysmal Supraventricular Tachycardia in an outpatient setting (i.e., without medical supervision).

Detailed Description

The NODE-302 study is an extension of the NODE-301 efficacy study. It is a multi-centre, open label study designed to evaluate the safety of etripamil NS 70 mg when self-administered by patients for spontaneous episodes of PSVT in an outpatient setting. All patients randomized in the NODE-301 study and who meet the inclusion and exclusion criteria of the NODE-302 study are eligible for the NODE-302 study.

After each episode of PSVT, patients will have the option to continue in the NODE-302 study and manage subsequent episodes of PSVT with etripamil NS 70 mg if they do not meet any withdrawal criteria.

Each episode of PSVT will be documented by an ambulatory cardiac monitoring system (CMS) that will be placed on the chest by the patient or caregiver when symptoms begin, and will record at least 5 hours of continuous ECG.

The study will include a Qualification Visit, a Treatment Period(s) , a Follow-up Visit(s) ,a Final Study Visit and if necessary an Early Termination Visit if the patient withdraws from the study after taking etripamil NS 70 mg and had a Follow-up Visit, or the patient withdraws from the study and did not take etripamil NS 70 mg.

Study Timeline

• Study First Submitted: 2018-08-14
• Study First Submitted QC: 2018-08-14
• Study First Posted: 2018-08-17
• Study Start: 2018-12-10
• Primary Completion: 2020-11-13
• Study Completion: 2020-11-13
• Status Verified: 2021-03
• Disposition First Submitted: 2021-03-23
• Results First Submitted: 2023-03-08
• Results First Submitted QC: 2023-04-04
• Results First Posted: 2023-04-24
• Disposition First Posted: 2023-04-24
• Last Update Submitted: 2024-10-23
• Last Update Posted: 2024-11-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 169

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Etripamil NS 70 mg	Aptar Pharma Nasal Spray Bidose System	The dose of etripamil to be evaluated in NODE-302 is 70 mg.
Etripamil NS 70 mg	Etripamil NS 70 mg	The dose of etripamil to be evaluated in NODE-302 is 70 mg.

Primary Outcome Measures

Name	Time	Method
Time to Conversion of an Episode of PSVT to Sinus Rhythm (SR) After Study Drug Administration.	18 months	The efficacy analyses were performed on the Efficacy Population. The primary efficacy variable was the time to conversion of an episode of PSVT to SR after study drug administration.

Trial Locations

Locations (34)

Arizona Arrhythmia Research Center; 🇺🇸 Phoenix, Arizona, United States

Arkansas Cardiology; 🇺🇸 Little Rock, Arkansas, United States

Los Alamitos Cardiovascular; 🇺🇸 Los Alamitos, California, United States

South Denver Cardiology Associates, P.C; 🇺🇸 Littleton, Colorado, United States

Baptist Health Ambulatory Services; 🇺🇸 Jacksonville, Florida, United States

Mayo Clinic - Jacksonville; 🇺🇸 Jacksonville, Florida, United States

Edgewater Medical Research; 🇺🇸 New Smyrna Beach, Florida, United States

Piedmont Heart Institute; 🇺🇸 Atlanta, Georgia, United States

Columbus Regional Research Institute; 🇺🇸 Columbus, Georgia, United States

Georgia Arrythmia Consultants&Research Institute; 🇺🇸 Macon, Georgia, United States

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