CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 69 enrolled
Drug / intervention
Etripamil +1 moredrug
Likely dose
Etripamil 70 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04467905
NCT04467905Phase 2Completed
CompareCT.gov

Multi-Centre, Placebo-Controlled, Phase 2 Study of Etripamil Nasal Spray (NS) for the Reduction of Ventricular Rate in Patients With Atrial Fibrillation.

Milestone Pharmaceuticals Inc.·interventional·Posted Jul 13, 2020·Updated Sep 19, 2024

In Brief

A Phase 2 clinical trial evaluating Etripamil and Placebo for Atrial Fibrillation. Completed, enrolled 69 participants across 18 sites in 2 countries.

Detailed Summary

Many patients with atrial fibrillation (AF) experience persistent tachycardia with episodes of rapid ventricular rate despite chronic treatment to reduce ventricular rate. The objectives of this study were to demonstrate the superiority of a nasal spray of etripamil over placebo in reducing ventricular rate in patients with AF; and to evaluate the safety and efficacy of etripamil nasal spray in participants with AF.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation
CountriesCanada, Netherlands
CollaboratorsThe Montreal Health Innovations Coordinating Center (MHICC), JSS Medical Research Inc.

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedJul 13, 2020
Enrollment StartNov 19, 2020
Primary CompletionAug 3, 2023
Study CompletionAug 10, 2023
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 6.0 years ago

Interventions

Etripamildrug

The formulation of etripamil nasal spray consists of MSP-2017 (etripamil), water, acetic acid, disodium ethylene-diamine-tetra-acetic acid (EDTA), and sulfuric acid. The dose of etripamil to be evaluated in this study is 70 mg.

Placebodrug

The formulation of placebo nasal spray consists of water, sodium acetate, disodium, disodium ethylene-diamine-tetra-acetic acid (EDTA), and sulfuric acid to reproduce the same pH as the etripamil formulation.