NCT02296190

Efficacy and Safety of Intranasal MSP-2017 (Etripamil) for the Conversion of PSVT to Sinus Rhythm

Multi-Center, Placebo-Controlled, Dose-Ranging Phase 2 Electrophysiological Study of Intranasal Administration of MSP-2017 for the Conversion of Induced Paroxysmal Supraventricular Tachycardia (PSVT) to Sinus Rhythm

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 199 (actual)
• Sponsor: Milestone Pharmaceuticals Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to demonstrate the superiority of at least 1 dose of intranasal (IN) MSP-2017 (Etripamil) over placebo in terminating PSVT induced in an electrophysiology (EP) laboratory.

Detailed description

This is a multi-center, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the effects of 4 different doses of MSP-2017 (Etripamil) in subjects with paroxysmal supraventricular tachycardia. It includes an up to 21-day Screening Period, a 1-day Treatment Visit, and either a Follow-up Visit or Early Termination Visit occurring 12 hours to 5 days after the Treatment Visit. Subjects will be randomized to yield at least 100 evaluable subjects distributed into 5 groups of at least 20 subjects each.

Conditions

• Paroxysmal Supraventricular Tachycardia (PSVT)

Interventions

Type	Name	Description
DRUG	Etripamil	intranasal administration via 4 prefilled Aptar Pharma Unit-Dose Spray devices
DRUG	Placebo	intranasal administration via 4 prefilled Aptar Pharma Unit-Dose Spray devices

Timeline

• Start date: 2015-03-27
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2014-11-20
• Last updated: 2020-12-30
• Results posted: 2020-12-30

Locations

30 sites across 2 countries: United States, Canada