Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Efficacy, and Safety Study of Etripamil Nasal Spray for the Termination of Spontaneous Episodes of Paroxysmal Supraventricular TachycardiaThe RAPID Study (NODE-301 Part 2)

Milestone Pharmaceuticals Inc.0 sites700 target enrollmentApril 1, 2021

ConditionsTreatment of Paroxysmal Supraventricular Tachycardia MedDRA version: 20.0Level: LLTClassification code 10034044Term: Paroxysmal supraventricular tachycardiaSystem Organ Class: 100000004849 Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Treatment of Paroxysmal Supraventricular Tachycardia
Sponsor: Milestone Pharmaceuticals Inc.
Enrollment: 700
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

April 1, 2021

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Milestone Pharmaceuticals Inc.

Eligibility Criteria

Inclusion Criteria

•Patients who meet all of the following criteria will be eligible to participate in the study:
•1\. Male or female patients at least 18 years of age;
•2\. Electrographically documented history of PSVT (e.g., ECG obtained during an episode of
•PSVT, Holter monitoring, loop recorder, etc.). If patient had a prior ablation for PSVT, patient
•must have documented ECG evidence of PSVT post\-ablation;
•3\. History of sustained episodes of PSVT (i.e., typically lasting approximately 20 minutes or
•4\. Females of childbearing potential who are sexually active with a male partner who is not
•surgically sterile (i.e., vasectomy) must agree to use an approved highly effective form of
•contraception from the time of signed informed consent until 30 days after the last
•administration of study drug. Females of childbearing potential should have a negative serum

Exclusion Criteria

•Patients who meet any of the following criteria will be excluded from participation in the study:
•1\. Systolic blood pressure \<90 mmHg after a 5\-minute rest in sitting position at the Screening Visit or before the test dose. In patients treated with a chronic prophylactic drug for PSVT (e.g., beta\-blockers, verapamil, and diltiazem), the drug may be stopped for at least the equivalent of 5 half\-lives and patients may be rescreened once;
•2\. History of severe symptoms of hypotension, especially syncope, during episodes of PSVT;
•3\. History of atrial arrhythmia that does not involve the AV node as part of the tachycardia circuit (e.g., atrial fibrillation, atrial flutter, intra\-atrial tachycardia);
•4\. History of allergic reaction to verapamil;
•5\. Current therapy with digoxin or any Class I or III antiarrhythmic drug, except if these drugs are stopped at least the equivalent of 5 half\-lives before the Test Dose Randomization Visit;
•6\. Current chronic therapy with oral amiodarone, or have taken oral amiodarone within 30 days prior to the Test Dose Randomization Visit;
•7\. Evidence of ventricular pre\-excitation (e.g., delta waves, short PR interval \<100 msec, Wolff\-Parkinson\-White syndrome) on the ECG performed at the Screening Visit or before the test dose administration;
•8\. Evidence of a second\- or third\-degree AV block on the ECG performed at the Screening Visit or before the test dose administration;
•9\. History or evidence of severe ventricular arrhythmia (e.g., torsades de pointes, ventricular fibrillation, or sustained ventricular tachycardia);