Multi-Centre, Open-Label, Safety Study of Etripamil Nasal Spray in Spontaneous Episodes of Paroxysmal Supraventricular Tachycardia The NODE-302 Trial (Extension of NODE-301)
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).
• Patients who meet all of the following criteria will be eligible to participate in the study:
• Male or female patients at least 18 years of age;
• Signed the NODE-302 written informed consent;
• Previously randomized in the NODE-301 study:
• Received the study drug to treat symptoms the patient believed were consistent with an episode of PSVT during the NODE-301 study, irrespective of the study drug efficacy; OR
• Did not experience an episode of PSVT or did not use the study drug at the time of the NODE-301 study completion;
• 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;
• The following categories define females who are NOT considered to be of childbearing potential:
• Premenopausal females with 1 of the following:
• Documented hysterectomy,
• Documented bilateral salpingectomy, or
• Documented bilateral oophorectomy, or
• Postmenopausal females, defined as having amenorrhea for at least 12 months without an alternative medical cause; and
• Male patients, except those who are surgically sterile, must use an approved highly effective form of contraception during the 3 days after study drug administration.