Treatment of Paroxysmal Supraventricular Tachycardia MedDRA version: 20.0 Level: LLT Classification code 10034044 Term: Paroxysmal supraventricular tachycardia System Organ Class: 100000004849
Conditions
Interventions
Product Name: Etripamil Nasal Spray
Product Code: MSP-2017
Pharmaceutical Form: Nasal spray, solution
INN or Proposed INN: Etripamil
CAS
Sponsors
Milestone Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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 SVT that includes the AV node as a critical part of reentrant circuit. 2) Is of 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 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 975 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 525
Exclusion criteria
Exclusion 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 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: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the safety of self-administered etripamil nasal spray (NS) outside of the clinical setting.; Secondary Objective: 1. To evaluate the efficacy of self-administered etripamil NS outside of the clinical setting, and 2. To evaluate the impact of etripamil NS on PSVT disease burden, and 3. To evaluate the safety and efficacy of etripamil NS when used for multiple PSVT episodes ;Primary end point(s): Number of participants presenting Adverse Events and/or number of participants with abnormal findings from the Cardiac Monitoring System recordings and physical examinations. ; Timepoint(s) of evaluation of this end point: It is estimated that 10 months will be needed to accrue enough documented self-administrations of etripamil NS in the safety database to meet regulatory requirements for the etripamil NS development program. When the criteria for concluding the study have been met, the Sponsor will announce a common study end date (CSED) for the entire study, and sites will be informed in advance to schedule all final patient visits prior to the CSED. The common study end date (CSED) for the entire study will depend on the rate of accrual of unique patients with an episode. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Frequency of additional medical intervention to treat PSVT, as measured by emergency department (ED) visits, inpatient and outpatient hospital admissions, and concomitant medication use. • Improvement in patient quality of life, as measured by the Patient Reported Outcomes (PRO) System. • Patient satisfaction with treatment, as measured by the Treatment Satisfaction Questionnaire for Medication (TSQM-9) and other questions. • Termination of PSVT episodes (as measured by mean and median time to conversion and proportion of patients converting at at 3, 5, 10, 15, 20, 30, and 60 minutes after etripamil NS administration.) ;Timepoint(s) of evaluation of this end point: It is estimated that 10 months will be needed to accrue enough documented self-administrations of etripamil NS in the safety database to enable assessment of these endpoints. | — |
Countries
Argentina, Belgium, Brazil, Canada, Chile, Colombia, Czech Republic, Denmark, France, Germany, Hungary, Israel, Italy, Mexico, Netherlands, Poland, Romania, Russian Federation, Slovakia, South Africa, Spain, Ukraine, United Kingdom, United States
Contacts
Public ContactGuy Rousseau
Milestone Pharmaceuticals Inc.
Outcome results
None listed