The NODE-202 Study (Study of Etripamil Nasal Spray in Pediatric Patients)
Status:
Not yet recruiting
Trial end date:
2027-06-30
Target enrollment:
Participant gender:
Summary
NODE-202 is a Phase 2, multicenter, multinational, single dose, open-label, 2-part,
sequential design study in pediatric patients with an established diagnosis of paroxysmal
supraventricular tachycardia (PSVT) presenting with a symptomatic episode of PSVT.
In Part 1, at least 30 patients aged 12 to <18 years will be enrolled and treated with
etripamil nasal spray (NS). Efficacy, safety, tolerability and PK (for at least 12 patients)
will be assessed after administration of 70 mg etripamil NS (Part 1A). At least 18 subsequent
patients will be enrolled and treated with the etripamil NS with the dose determined by the
Pharmacokinetic (PK) analysis and will undergo efficacy and safety/tolerability assessments
(Part 1B).
In Part 2, at least 30 patients aged 6 to <12 years will be enrolled and treated with
etripamil NS at a dose selected based on appropriate body size-based modeling, as well as
efficacy, safety/tolerability, and PK data collected in Part 1. Efficacy, safety,
tolerability and PK (for at least 12 patients) will be assessed after administration of
etripamil NS (Part 2A). At least 18 subsequent patients will be enrolled and treated with the
etripamil NS with the dose determined by the PK analysis and will undergo efficacy and
safety/tolerability assessments (Part 2B).
The study will include the following visits: A Screening Visit, A Treatment Visit, , and A
Follow-Up/End of Study Visit.