Safety Study of Etripamil Nasal Spray for Patients With Paroxysmal Supraventricular Tachycardia. NODE-303

• Status: Recruiting
• Trial end date: 2021-08-31
• Target enrollment: 0
• Participant gender: All

Summary

NODE-303 is a multi-center, open label (OL) study to evaluate the safety of etripamil NS in patients with Paroxysmal Supraventricular Tachycardia (PSVT). Patients will be provided with an ambulatory Cardiac Monitoring System (CMS) to help document PSVT episodes. The CMS will be self-applied by the patient, when PSVT symptoms begin. Patients will self-administer etripamil NS if vagal maneuver is ineffective. After an episode of PSVT where drug is administered, the patient will return to the investigative site for a study visit and will be given the option to continue in NODE-303 and manage subsequent episodes of PSVT with etripamil NS.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Milestone Pharmaceuticals Inc.
• Collaborator: IQVIA Biotech
• Treatments: Etripamil

Criteria

Inclusion Criteria:

A patient will be eligible for study participation if they meet all of the following criteria:

1. Has been diagnosed with PSVT by a medical professional, and reports having at least one previous episode of PSVT. For clarity, PSVT refers to episodic Supraventricular Tachycardia (SVT) that includes the atrioventricular (AV) node as a critical part of reentrant circuit.

2. Is at least 18 years of age;

3. Signed NODE-303 written informed consent

4. Women of child-bearing potential must be willing to use at least 1 form of contraception during the trial, and must be willing to discontinue from the study should they become or plan to become pregnant

5. Willing and able to comply with study procedures

Exclusion Criteria:

A patient will be excluded from the study if they meet any of the following criteria:

1. Patients with only a history of atrial arrhythmia that does not involve the atrioventricular (AV) node as part of the tachycardia circuit (e.g. atrial fibrillation, atrial flutter, intra-atrial tachycardia) are not eligible. Patients with a history of these tachycardias who are also diagnosed with PSVT are eligible.

2. History of allergic reaction to verapamil

3. Current therapy with digoxin, or any Class I or III antiarrhythmic drug. Patients may be eligible if these drugs are stopped at least five half-lives before the administration of etripamil NS. The only exception is amiodarone which must be stopped 30 days before enrollment.

4. History of ventricular pre-excitation, e.g., delta waves, Wolff- Parkinson-White syndrome

5. History of a second- or third-degree AV block

6. Symptoms of congestive heart failure New York Heart Association Class II to IV

7. Significant physical or psychiatric condition including alcoholism or drug abuse, which, in the opinion of the Investigator, could jeopardize the safety of the patient, or impede the patient's capacity to follow the study procedures

8. History of syncope due to an arrhythmic etiology at any time, or history in last 5 years of unexplained syncope

9. Is pregnant or breastfeeding

10. Previously enrolled in a clinical trial for etripamil and received study drug

11. History of Acute Coronary Syndrome (ACS) or stroke within 6 months of screening

12. 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 patients <60 years of age;

2. <40mL/min/1.73m2 for patients ≥60 and <70 years of age c) <35mL/min/1.73m2 for patients ≥70 years of age