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NCT05763953 · ClinicalTrials.gov registry record · Phase 2
The NODE-202 Study (Study of Etripamil Nasal Spray in Pediatric Patients)
A Phase 2 study of Paroxysmal Supraventricular Tachycardia, sponsored by Milestone Pharmaceuticals.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 10
- Study locations
NCT05763953 is a Phase 2 study of Paroxysmal Supraventricular Tachycardia that is actively recruiting participants, run by Milestone Pharmaceuticals. The registered enrollment target is 60 participants. The trial reports 10 study locations across 7 states.
The verdict
NCT05763953, a Phase 2 study of Paroxysmal Supraventricular Tachycardia, is actively recruiting participants, sponsored by Milestone Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 10
- Study locations
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.
Conditions Studied
Interventions
- DRUG Etripamil NS
Study Locations (10)
Other
- The University of British Columbia - Vancouver
- Universitätsmedizin Göttingen, Klinik für Pädiatrische Kardiologie, Intensivmedizin und Neonatologie - Göttingen
- Hospital Sant Joan de Déu - Barcelona
- Hospital Infantil Universitario La Paz - Madrid
Arizona
- Phoenix Children's Hospital - Phoenix
Illinois
- Advocate Children's Hospital - Oak Lawn
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Oregon
- Oregon Health and Science University - Portland
Tennessee
- Le Bonheur Children's Hospital - Memphis
Texas
- Baylor College of Medicine - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2023-12-11 |
| Est. Completion | 2027-06-30 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05763953
The ClinicalTrials.gov registry entry for NCT05763953 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Milestone Pharmaceuticals, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Paroxysmal Supraventricular Tachycardia appearing as the primary indexed condition, and to 1 intervention - of which Etripamil NS is the first listed.
NCT05763953 reports 10 study locations spanning 7 distinct geographic areas - top geographies include Other, Arizona, Illinois.
Frequently Asked Questions
What is clinical trial NCT05763953 about?
NCT05763953 is a clinical study titled "The NODE-202 Study (Study of Etripamil Nasal Spray in Pediatric Patients)". 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...
What is the current status of trial NCT05763953?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2023-12-11. Estimated completion is 2027-06-30.
What conditions does trial NCT05763953 study?
This clinical trial studies the following conditions: Paroxysmal Supraventricular Tachycardia.
What interventions are being tested in trial NCT05763953?
The interventions under investigation include: Etripamil NS (DRUG).
Who is sponsoring clinical trial NCT05763953?
This trial is sponsored by Milestone Pharmaceuticals, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05763953 being conducted?
This trial has 10 study locations across Arizona, Illinois, Ohio, Oregon, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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