Condition: Paroxysmal Supraventricular Tachycardia · Sponsor: Milestone Pharmaceuticals Inc.
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.
This description comes directly from the study's public registry record.
Cameron Szakacs, PhD · 704-807-6520 · cszakacs@milestonepharma.com
Always discuss trial participation with your own doctor first.
| Phoenix Children's Hospital | Phoenix, Arizona, United States | Recruiting |
| Advocate Children's Hospital | Oak Lawn, Illinois, United States | Not Yet Recruiting |
| Cincinnati Children's Hospital Medical Center | Cincinnati, Ohio, United States | Not Yet Recruiting |
| Oregon Health and Science University | Portland, Oregon, United States | Recruiting |
| Le Bonheur Children's Hospital | Memphis, Tennessee, United States | Not Yet Recruiting |
| Baylor College of Medicine | Houston, Texas, United States | 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 |
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Source record: clinicaltrials.gov/study/NCT05763953