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 enrollmentOctober 13, 2020

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Milestone Pharmaceuticals Inc.
Enrollment: 700
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 13, 2020

End Date

TBD

Last Updated

4 years ago

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 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 an approved form of contraception between the visits. Approved forms of contraception include hormonal intrauterine devices or hormonal contraceptives (oral birth control pills, Depo\-Provera?, patch, or other injectables) together with a supplementary barrier method, such as condoms or diaphragms with spermicidal gel or foam;
•The following categories define females who are NOT considered to be of childbearing potential:
•Premenopausal females with 1 of the following:
•Documented hysterectomy;
•Documented bilateral salpingectomy or tubal ligation; or
•Documented bilateral oophorectomy; or

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