The NODE-202 Study (Study of Etripamil Nasal Spray in Pediatric Patients)
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study 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.
Eligibility
Primary outcome measure(s)
- Efficacy: The percentage of patients converting to sinus rhythm (SR) in the first 15 minutes after administration of etripamil NS. — 15 minutes after administration of etripamil NS
A successful conversion is defined as conversion of PSVT to SR that is maintained for at least 30 seconds
Trial sites (10)
| Facility | City | Region | Status |
|---|---|---|---|
| Phoenix Children's Hospital | Phoenix | Arizona | Recruiting |
| Advocate Children's Hospital | Oak Lawn | Illinois | Not Yet Recruiting |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | Not Yet Recruiting |
| Oregon Health and Science University | Portland | Oregon | Recruiting |
| Le Bonheur Children's Hospital | Memphis | Tennessee | Not Yet Recruiting |
| Baylor College of Medicine | Houston | Texas | Not Yet Recruiting |
| The University of British Columbia | Vancouver | Canada | Not Yet Recruiting |
| Universitätsmedizin Göttingen, Klinik für Pädiatrische Kardiologie, Intensivmedizin und Neonatologie | Göttingen | Germany | Not Yet Recruiting |
| Hospital Sant Joan de Déu | Barcelona | Spain | Not Yet Recruiting |
| Hospital Infantil Universitario La Paz | Madrid | Spain | Recruiting |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05763953 on ClinicalTrials.gov ↗ ← All trials in Germany