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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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-500319-38-00
Acronym
MSP-2017-1265
Enrollment
30
Registered
2023-08-21
Start date
2024-05-03
Completion date
Unknown
Last updated
2025-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paroxysmal supraventricular tachycardia (PSVT)

Brief summary

Efficacy: The percentage of patients converting to SR in the first 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.

Detailed description

Time to termination of the PSVT episode and conversion to sinus rhythm (SR), Percentage of patients requiring additional medical intervention treatment for the PSVT episode in the first 15 minutes after study drug administration, Frequency of AEs, Local (administration site) tolerability, Post-dose changes in vital signs (HR and BP)

Interventions

Sponsors

Milestone Pharmaceuticals Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
Efficacy: The percentage of patients converting to SR in the first 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.

Secondary

MeasureTime frame
Time to termination of the PSVT episode and conversion to sinus rhythm (SR), Percentage of patients requiring additional medical intervention treatment for the PSVT episode in the first 15 minutes after study drug administration, Frequency of AEs, Local (administration site) tolerability, Post-dose changes in vital signs (HR and BP)

Countries

Germany, Netherlands, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026