Etripamil Nasal Spray in Patients With Paroxysmal Supraventricular Tachycardia (NCT04952610) | Clinical Trial Compass
By InvitationPhase 3
Etripamil Nasal Spray in Patients With Paroxysmal Supraventricular Tachycardia
United States130 participantsStarted 2021-12-13
Plain-language summary
This Open Label Extension study will enable eligible patients with Paroxysmal Supraventricular Tachycardia (PSVT) who have previously participated in a Milestone Pharmaceuticals clinical trial of etripamil NS for PSVT, to access continued treatment with etripamil NS, Patients who experienced any significant safety issues during participation period in a previous clinical trial of etripamil NS, as per Investigator's assessment , are excluded. This study will be conducted by Investigators who previously participated in a Milestone Pharmaceuticals clinical trial and are trained on the use of etripamil NS.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Has participated in a Milestone Pharmaceuticals Inc. clinical research trial of etripamil NS for the treatment of PSVT (NODE-301 Part1, RAPID (NODE-301 Part 2), NODE-302, or NODE-303.
✓. Has signed the MSP-2017-1278 written informed consent;
✓. Women of childbearing potential who are sexually active with a male partner who is not surgically sterile (i.e., vasectomy) must be willing to use at least 1 form of highly effective contraception from the time of signed informed consent until 7 days after the last administration of etripamil NS and must be willing to discontinue from the study should they become or plan to become pregnant.
✓. Documented hysterectomy; or
✓. Documented bilateral salpingectomy; or
✓. Documented bilateral oophorectomy; or
✓. Willing and able to comply with Investigator instructions on etripamil NS use and study requirements.
Exclusion criteria
✕. History of allergic reaction to verapamil, etripamil, or any of the investigational medical components;
What they're measuring
1
The safety of self-administered etripamil Nasal Spray (NS) for treatment of episodes of PSVT outside of the clinical setting as assessed by patient-reported adverse events.
✕. Current chronic 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 enrollment. The only exception is oral amiodarone which must be stopped 30 days before enrollment;
✕. History of ventricular pre-excitation, e.g., delta waves, Wolff-Parkinson-White syndrome;
✕. History of a second- or third-degree atrioventricular block;
✕. History of sick sinus syndrome and marked bradycardia (≤40 beats/minute);
✕. History or evidence of severe ventricular arrhythmia (e.g. torsades de points, ventricular fibrillation, or sustained ventricular tachycardia)
✕. Symptoms of congestive heart failure New York Heart Association Class II to IV;
✕. 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 requirements;