Actively Recruiting
The NODE-202 Study (Study of Etripamil Nasal Spray in Pediatric Patients)
Led by Milestone Pharmaceuticals Inc. · Updated on 2025-08-01
60
Participants Needed
10
Research Sites
185 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
The NODE-202 Study (Study of Etripamil Nasal Spray in Pediatric Patients)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 12 to under 18 years (Part 1) or 6 to under 12 years (Part 2)
- Body mass index (BMI) between the 5th and 85th percentiles for age and sex
- Documented history of PSVT confirmed by ECG or monitoring device, including AVNRT or AVRT
- Signed written informed consent or assent
- Females of childbearing potential must have a negative pregnancy test and use adequate contraception or total abstinence
- Willing and able to comply with study procedures
You will not qualify if you...
- History of atrial arrhythmias not involving the AV node (e.g., atrial fibrillation, flutter, or tachycardia)
- Permanent junctional reciprocating tachycardia
- Ventricular pre-excitation such as Wolff Parkinson White syndrome
- Second- or third-degree AV block
- Sick sinus syndrome or significant bradycardia (heart rate below 50 bpm)
- Ventricular tachycardia
- Long QT syndrome
- Major structural heart disease or symptoms of congestive heart failure (NYHA class II-IV)
- Impaired liver function with elevated ALT or AST above 3 times the upper limit for age and gender
- End-stage renal disease with eGFR below 15 mL/min/1.73m2 or requiring hemodialysis
- Treatment with certain investigational or antiarrhythmic drugs within specified timeframes prior to study
- Known hypersensitivity to verapamil or any component of the study drug
- Significant co-morbid conditions that may affect participation or compliance
- History of hyperthyroidism
- Current pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 10 locations
1
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
Actively Recruiting
2
Advocate Children's Hospital
Oak Lawn, Illinois, United States, 60453
Not Yet Recruiting
3
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Not Yet Recruiting
4
Oregon Health and Science University
Portland, Oregon, United States, 97239
Actively Recruiting
5
Le Bonheur Children's Hospital
Memphis, Tennessee, United States, 38103
Not Yet Recruiting
6
Baylor College of Medicine
Houston, Texas, United States, 77030
Not Yet Recruiting
7
The University of British Columbia
Vancouver, Canada, V6H3V4
Not Yet Recruiting
8
Universitätsmedizin Göttingen, Klinik für Pädiatrische Kardiologie, Intensivmedizin und Neonatologie
Göttingen, Germany, 37075
Not Yet Recruiting
9
Hospital Sant Joan de Déu
Barcelona, Spain, 08950
Not Yet Recruiting
10
Hospital Infantil Universitario La Paz
Madrid, Spain, 28046
Actively Recruiting
Research Team
C
Cameron Szakacs, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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