Calendario›MIST›Etripamil NS

Etripamil NS

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

Ensayo de Milestone Pharmaceuticals Inc. en Paroxysmal Supraventricular Tachycardia (del registro, en inglés).

Fase

Fase 2

Estado

Reclutando pacientes

Participantes

60

previstos

Centros

10

Fin del objetivo primario

jun 2027

estimado por el promotor

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en dic 2023.

Qué mide

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) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroNODE-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.

Más ensayos de MIST

Todos los de MIST, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT05763953), actualizada en jul 2026.