The NODE-303 Study: Multi-Centre, Multi-National,Open Label, Safety Study of Etripamil Nasal Spray for Patients With Paroxysmal Supraventricular Tachycardia.

NODE-303

NODE-303 was a multi-center, open label study to evaluate the safety of etripamil NS in participants with Paroxysmal Supraventricular Tachycardia (PSVT). Participants were provided with an ambulatory Cardiac Monitoring System (CMS) to help document PSVT episodes. The CMS was self-applied by the participant, when they felt the onset of PSVT symptoms. Participants self-administered etripamil NS if vagal maneuver was ineffective. After an episode of PSVT where study drug was administered, the participant returned to the investigative site and had the option to continue in NODE-303 and manage up to three subsequent episodes of PSVT with etripamil NS for a maximum of four episodes.

2019-09-23

2023-01-26

2023-01-26

Completed

Early phase I

1116

Inclusion Criteria: A participant was eligible for study participation if they met all of the following criteria: 1. Had been diagnosed with PSVT by a medical professional, and reported having at least one previous episode of PSVT. For clarity, PSVT referred to episodic Supraventricular Tachycardia (SVT) that included the atrioventricular (AV) node as a critical part of reentrant circuit. 2. Was at least 18 years of age; 3. Signed NODE-303 written informed consent 4. Women of childbearing potential had to be willing to use at least 1 form of contraception during the trial, and had to be willing to discontinue from the study should they have become or planned to become pregnant. Postmenopausal females were defined as having amenorrhea for at least 12 months prior to Screening without an alternative medical cause. 5. Willing and able to comply with study procedures Exclusion Criteria: A participant was excluded from the study if they met any of the following criteria: 1. Participants with only a history of atrial arrhythmia that did not involve the atrioventricular (AV) node as part of the tachycardia circuit (e.g. atrial fibrillation, atrial flutter, intra-atrial tachycardia) were not eligible. Participants with a history of these tachycardias who were also diagnosed with PSVT were eligible. 2. History of allergic reaction to verapamil 3. Current therapy with digoxin, or any Class I or III antiarrhythmic drug. Participants could be eligible if these drugs were stopped at least five half-lives before the administration of etripamil NS. The only exception was amiodarone which had to be stopped 30 days before enrollment. 4. History or evidence of ventricular pre-excitation, e.g., delta waves, Wolff- Parkinson-White syndrome 5. History or evidence of a second- or third-degree AV block 6. History or evidence of severe ventricular arrhythmia (e.g., torsades de pointes, ventricular fibrillation, or sustained ventricular tachycardia). 7. Symptoms of congestive heart failure New York Heart Association Class II to IV 8. SBP \< 90 mmHg at Screening, Baseline or any Follow-up Visit. 9. Severe symptoms of hypotension experienced during PSVT episodes. 10. Significant physical or psychiatric condition including alcoholism or drug abuse, which, in the opinion of the Investigator, could jeopardize the safety of the participant, or impede the participant's capacity to follow the study procedures 11. History of syncope due to an arrhythmic etiology at any time, or history in last 5 years of unexplained syncope 12. Was pregnant or breastfeeding 13. Previously enrolled in a clinical trial for etripamil and received study drug or participation in any clinical trial for other investigational products or medical devices within 30 days of Screening. 14. History of Acute Coronary Syndrome (ACS) or stroke within 6 months of screening 15. Evidence of renal dysfunction as determined by an estimated glomerular filtration rate assessed at the Screening Visit as follows: 1. \<60mL/min/1.73m2 for participants \<60 years of age; 2. \<40mL/min/1.73m2 for participants ≥60 and \<70 years of age 3. \<35mL/min/1.73m2 for participants ≥70 years of age

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2024-05-23