Last updated on August 2019

Efficacy and Safety of Etripamil for the Termination of Spontaneous PSVT. NODE-301

Brief description of study

The primary objective of this study is to determine whether etripamil nasal spray (NS) 70 mg is superior to placebo at terminating episodes of PSVT in an outpatient setting.

Detailed Study Description

NODE-301 is a multi-centre, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of a nasal spray of etripamil, a new calcium channel blocker, in patients who experience an episode of paroxysmal ventricular tachycardia (PSVT).

The study includes a Screening Visit during which prospective study patients suffering episodes of PSVT will sign the informed consent form. All patients will receive a test dose of etripamil nasal spray 70 mg to evaluate the tolerability of etripamil under medical supervision including continuous ECG. A patient will be randomized only if the test dose is well tolerated.

All the randomized patients will be trained to recognize the symptoms of PSVT, perform a vagal maneuver, and self-administer the nasal spray study drug to terminate the episode of PSVT. The patient will place an ambulatory cardiac monitoring system (CMS) on the chest at the onset of symptoms to record at least 5 hours of continuous ECG and document the tachycardia and its termination. A Final Study Visit will occur at the study site within 7 days after the episode to evaluate the clinical effects of the study drug and to review the report of the CMS data.

Follow-up Visits will occur approximately monthly from the time of randomization and will be conducted in person at the site or by telephone.

Clinical Study Identifier: NCT03464019

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