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 enrollmentNovember 17, 2020

Overview

No summary available.

Registry

who.int

Start Date

November 17, 2020

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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 a 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 pregnancy test result at the Screening Visit and at the Final Study Visit, a negative urine pregnancy test at the Test
•Dose Randomization Visit and must use a highly effective form of contraception between the visits.
•5\. Male patients, except those who are surgically sterile, must use a highly effective form of contraception during the 3 days after any study drug administration; and
•6\. Signed written informed consent.

•Patients who meet any of the following criteria will be excluded from participation in the study:
•1\. Systolic blood pressure (SBP) \<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, patients may be rescreened once, and chronic use of the drug cannot be restarted after randomization;
•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;