Study to Investigate the Safety of Etripamil Nasal Spray for Patients with Paroxysmal Supraventricular Tachycardia
- Conditions
- Treatment of Paroxysmal Supraventricular TachycardiaMedDRA version: 20.0Level: LLTClassification code 10034044Term: Paroxysmal supraventricular tachycardiaSystem Organ Class: 100000004849Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2019-001857-13-GB
- Lead Sponsor
- Milestone Pharmaceuticals Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 3000
1)Has been diagnosed as having recurrent episodes of PSVT by a medical professional, and is familiar with the symptoms that occur at the initiation of the arrhythmia. For clarity, PSVT refers to episodic SVT that includes the AV node as a critical part of reentrant circuit. See Section 6.4 for details on diagnostic criteria.
2) Is of at least 18 years of age
3) Signed NODE-303 written informed consent
4) Women of child-bearing potential who are sexually active must be willing to use at least 1 form of contraception from the time of signed informed consent until 7 days after the last administration of study drug, and must be willing to discontinue from the study should they become or plan to become pregnant
Approved forms of contraception include hormonal intrauterine devices or hormonal contraceptives (oral birth control pills,
DepoProvera?,patch, or other injectables) or single barrier methods 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:
a) Documented hysterectomy;
b) Documented bilateral salpingectomy; or
c) Documented bilateral oophorectomy; or
d) Postmenopausal females, defined as having amenorrhea for at least
12 months without an alternative medical cause.
All females who do not meet the above criteria are considered to be of childbearing potential.
5) Willing and able to comply with study procedures
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1950
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1050
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, etripamil or any of the investigational medical components
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) History of sick sinus syndrome and marked bradycardia (<50 beats/minute)
7) Symptoms of congestive heart failure New York Heart Association Class II to IV
8) 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
9) History of syncope due to an arrhythmic etiology at any time, or history in last 5 years of unexplained syncope
10) Is pregnant or breastfeeding
11) Previously enrolled in a clinical trial for etripamil and received study drug
12) History of ACS or stroke within 6 months of screening
13) Evidence of renal dysfunction as determined by an estimated glomerular filtration rate assessed at the Screening Visit as follows:
a)<60mL/min/1.73m2 for patients <60 years of age;
b)<40mL/min/1.73m2 for patients =60 and <70 years of age
c)<35mL/min/1.73m2 for patients =70 years of age
14) SBP<90 mmHg
15) Has known allergies to adhesive materials or hydrogel used in the Cardiac Monitoring Device
16) Evidence of hepatic dysfunction defined as alanine aminotransferase or aspartate aminotransferase >3 times the upper limit of normal (ULN) or total bilirubin >2 times the ULN at the Screening Visit, unless due to Gilbert syndrome
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method