Conditions: Paroxysmal Supraventricular Tachycardia (PSVT)
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 199
Healthy volunteers: no

Brief 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.

Arms:
arm 1: 1 dose of Etripamil via 4 intranasal applications at time 0 (140 mg, 105 mg, 70 mg, or 35 mg) arm 2: 1 dose of placebo via 4 intranasal applications at time 0

Interventions: intervention 1: Etripamil intervention 2: Placebo
Intervention descriptions: intervention 1: intranasal administration via 4 prefilled Aptar Pharma Unit-Dose Spray devices intervention 2: intranasal administration via 4 prefilled Aptar Pharma Unit-Dose Spray devices

Protocol document: