Completed Clinical Trials
A Phase 1 clinical trial was designed to assess the safety, pharmacokinetic profile, and cardiac pharmacology of intranasally administered etripamil in a randomized, placebo-controlled, single ascending dose design. Among healthy volunteers living with paroxysmal supraventricular tachychardia (PSVT), results showed rapid absorption into the bloodstream and modulation of the atrioventricular (AV) node, as measured by prolongation of the PR interval via electrocardiogram (ECG or EKG). These Phase 1 results supported the selection of four doses of etripamil for the Phase 2 clinical trial.
A Phase 2 clinical trial (NODE-1) was completed in PSVT patients in the electrophysiology (EP) laboratory setting. NODE-1 was a multi-center, randomized, double-blind, placebo-controlled study conducted in the United States and Canada to evaluate the effects of four different doses of etripamil (35 mg, 70 mg, 105 mg, 140 mg) or placebo in PSVT patients with a scheduled cardiac ablation. Subjects were randomized to yield 104 evaluable subjects distributed into five groups of at least 20 subjects each. The primary objective of this study was to demonstrate the superiority of at least one dose of intranasal etripamil over placebo in terminating induced PSVT. The secondary objectives were to determine the minimal effective dose of etripamil, to establish a dose-related trend for etripamil, and to evaluate the safety of etripamil in a clinical setting. The primary endpoint was the conversion of PSVT to sinus rhythm within 15 minutes after administration of the investigational treatment.
See a description of our Phase 2 clinical trial on clinical.trials.gov.
Access the full text published in the Journal of the American College of Cardiology below.
Actively Enrolling Clinical Trials
A Phase 3 clinical trial (Node-301) is a multicenter, randomized, double-blind, placebo-controlled, event-driven study, planned to be conducted in more than 50 cardiology centers in the United States and Canada and will enroll up to 500 patients with a documented history of PSVT. Following an in-office test dose of etripamil, patients will take home either 70 mg of etripamil or placebo for when a PSVT episode occurs. Upon onset of an episode, patients will apply a wireless cardiac monitor to their chest to record their heart rhythm, perform a vagal maneuver, and if symptoms persist, administer study drug. The primary endpoint of the NODE-301 study is time to conversion of PSVT to sinus rhythm after the administration of study drug as confirmed by a central independent adjudication committee. Secondary study endpoints include relief of symptoms commonly associated with an episode of PSVT such as heart palpitations, chest pain, anxiety, shortness of breath, dizziness, and fainting.
Patients receiving study treatment in NODE-301 will be eligible to participate in an open-label extension study (NODE-302) where etripamil will be provided for subsequent PSVT episodes.
See a description of our Node-301 Phase 3 clinical trial on clinical.trials.gov.
See a description of our Node-302 Phase 3 clinical trial on clinical.trials.gov.