Study of Etripamil Nasal Spray to Treat Paroxysmal Supraventricular Tachycardia in Children Aged 6 to 17 Years Phase 2, Multicenter, Open-Label Safety and Efficacy Trial

What this Trial Is About

Researchers are conducting a Phase 2, multinational study called NODE-202 to evaluate the efficacy, safety, and tolerability of etripamil nasal spray in children aged 6 to under 18 years with paroxysmal supraventricular tachycardia PSVT. This study is designed in two parts, focusing first on older children aged 12 to under 18 years and then younger children aged 6 to under 12 years, to better understand how the medication works and is tolerated in these age groups. Participants will receive etripamil nasal spray in a single dose during a symptomatic PSVT episode. In Part 1, at least 30 patients aged 12 to under 18 years will be treated with a 70 mg dose initially, followed by a dose adjusted based on pharmacokinetic analysis. In Part 2, at least 30 patients aged 6 to under 12 years will be treated with a dose selected from body size modeling and earlier data. The treatment is administered intranasally by study personnel under medical supervision and ECG monitoring. Participants will attend a screening visit to confirm eligibility and provide consent, a treatment visit when experiencing PSVT symptoms where diagnosis is confirmed and treatment given if appropriate, and a follow-up visit 1 to 5 days later to monitor safety and record any adverse events. Researchers will measure the percentage of patients returning to normal heart rhythm within 15 minutes after treatment and other safety and efficacy outcomes, with monitoring of vital signs and ECG changes during the study period.

The NODE-202 Study (Study of Etripamil Nasal Spray in Pediatric Patients)