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RECRUITING
NCT05763953
PHASE2

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

Sponsor: Milestone Pharmaceuticals Inc.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

6 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2023-12-11

Completion Date

2027-06-30

Last Updated

2025-08-01

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.

Locations (10)

Phoenix Children's Hospital

Phoenix, Arizona, United States

Advocate Children's Hospital

Oak Lawn, Illinois, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Oregon Health and Science University

Portland, Oregon, United States

Le Bonheur Children's Hospital

Memphis, Tennessee, United States

Baylor College of Medicine

Houston, Texas, United States

The University of British Columbia

Vancouver, Canada

Universitätsmedizin Göttingen, Klinik für Pädiatrische Kardiologie, Intensivmedizin und Neonatologie

Göttingen, Germany

Hospital Sant Joan de Déu

Barcelona, Spain

Hospital Infantil Universitario La Paz

Madrid, Spain