Safety Study of Intranasal Etripamil for the Termination of Spontaneous Episodes of Paroxysmal Su… (NCT03635996) | Clinical Trial Compass
TerminatedPhase 3
Safety Study of Intranasal Etripamil for the Termination of Spontaneous Episodes of Paroxysmal Supraventricular Tachycardia (PSVT). NODE-302
Stopped: Study was stopped by the Sponsor
United States169 participantsStarted 2018-12-10
Plain-language summary
The primary objective of this study is to evaluate the safety of etripamil nasal spray (NS) 70 mg when self-administered by patients with an episode of Paroxysmal Supraventricular Tachycardia in an outpatient setting (i.e., without medical supervision).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or female patients at least 18 years of age;
✓. Signed the NODE-302 written informed consent;
✓. Previously randomized in the NODE-301 study:
✓. Willing and able to comply with all aspects of the study;
✓. Females of childbearing potential who are sexually active 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 urine pregnancy test result at the Qualification Visit and at the Follow-up Visit(s), and must use an approved form of contraception between the 2 visits. Approved forms of contraception include hormonal intrauterine devices and hormonal contraceptives (oral birth control pills, Depo Provera®, patch, or other injectables) together with supplementary double barrier methods, such as condoms or diaphragms with spermicidal gel or foam;
✓. Documented hysterectomy,
✓. Documented bilateral salpingectomy, or
✓. Documented bilateral oophorectomy, or
Exclusion criteria
✕. Evidence of new severe arrhythmia discovered since the NODE-301 Test Dose Randomization Visit, including those reported on the Cardiac Monitoring System (CMS) report of the outpatient PSVT event treated with the study drug in the NODE 301 study:
✕. Any drug-related or procedure-related serious adverse event during the NODE-301 study;
What they're measuring
1
Time to Conversion of an Episode of PSVT to Sinus Rhythm (SR) After Study Drug Administration.
✕. Any severe adverse event (AE) in the NODE-301 study that was severe enough to preclude administration of etripamil NS 70 mg in the NODE-302 study;
✕. Any new drug prescribed after the end of the patient's participation in the NODE-301 study that could lower blood pressure or decrease AV node conduction;
✕. Systolic blood pressure \<90 mmHg after a 5-minute rest in sitting position at the NODE-302 Qualification Visit;
✕. Any symptoms consistent with clinically severe hypotension such as presyncope, medically significant lightheadedness, syncope, nausea, or vomiting;
✕. New therapy with digoxin, amiodarone, or any Class I or III antiarrhythmic drug added after the end of the patient's participation in the NODE-301 study;
✕. New evidence of ventricular pre-excitation (e.g., delta waves, short PR interval, Wolff Parkinson-White syndrome) on the ECG since randomization in the NODE-301 study;