Treatment of Paroxysmal Supraventricular Tachycardia MedDRA version: 20.0 Level: LLT Classification code 10034044 Term: Paroxysmal supraventricular tachycardia System Organ Class: 100000004849
Conditions
Sponsors
Milestone Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Inclusion 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 longer); 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. 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 500 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 200
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be excluded from participation in the study: 1. Systolic blood pressure (SBP) 3 × the upper limit of normal (ULN) or total bilirubin >2 × ULN at the Screening Visit, unless due to Gilbert syndrome; 13. Evidence of End-Stage Renal Disease as determined by an estimated glomerular filtration rate assessed at the Screening Visit of <15 mL/min/1.73m2or requiring hemodialysis; 14. Females who are pregnant or lactating; 15. Evidence or history of any significant physical or psychiatric condition including drug abuse, which, in the opinion of the Investigator, could jeopardize the safety of patients or affect their participation in the study. Additionally, the Investigator has the ability to exclude a patient if for any reason the Investigator judges the patient is not a good candidate for the study or will not be able to follow study procedures; 16. Participation in any investigational drug or device study or the use of any investigational drug or device within 30 days of the Screening Visit; or 17. Previously enrolled in a clinical trial for etripamil and received study drug during a perceived episode of PSVT.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the RAPID study is to determine whether Etripamil nasal spray (NS) self-administered by patients is superior to placebo at terminating episodes of PSVT in an at-home setting.;Secondary Objective: The secondary objective of this study is to evaluate the safety of Etripamil when self administered by patients without medical supervision.;Primary end point(s): The primary efficacy endpoint will be evaluated using the time to conversion of an episode of PSVT to SR after start of study drug administration as the primary efficacy variable.;Timepoint(s) of evaluation of this end point: The primary efficacy endpoint is defined as time to an adjudicated termination of a positively adjudicated episode of PSVT and conversion to SR for at least 30 seconds within 30 minutes of start of study drug dosing. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Study secondary Endpoints are the Sensitivity estimators, and are defined in the statistical analysis plan, and details are in the protocol v6.0 16Jul2020 section 9.2.4.1;Timepoint(s) of evaluation of this end point: time to conversion at 5, 10, 15, 45, 60, 90, 120, 180, 240, and 300 minutes. | — |
Countries
Belgium, Canada, France, Germany, Hungary, Netherlands, Poland, Spain, United States
Contacts
Public ContactGuy Rousseau
Milestone Pharmaceuticals Inc.
Outcome results
None listed