The NODE-202 Study Multi-Center, Multi-National, Open-Label, Efficacy and Safety Study of Etripamil Nasal Spray in Pediatric Patients With Paroxysmal Supraventricular Tachycardia

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.

Description

Eligibility

Age range

6–17 years

Sex

All

Healthy volunteers

No

Interventions

• Drug
  Etripamil NS

  Part 1A: At least 12 patients will be administered with Etripamil NS (35 mg/100 μL per nostril) at a dose of 70 mg. Part 1B: At least 18 following patients will be administered with Etripamil NS at a dose determined by analysis of data generated from Part 1A. Part 2A: At least 12 patients will be administered with Etripamil NS at a dose selected based on appropriate body size-based modeling using PK assessments, as well as safety/tolerability, and efficacy data collected in Part 1. Part 2B: At least 18 following patients will be administered with Etripamil NS at a dose determined by analysis of data generated from Part 2A.

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