Actively Recruiting
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
Led by Milestone Pharmaceuticals Inc. · Updated on 2025-08-01
60
Participants Needed
10
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the use of etripamil nasal spray (NS) in children aged 6 to under 18 years who have an established diagnosis of paroxysmal supraventricular tachycardia (PSVT) and are experiencing a symptomatic episode. This Phase 2, open-label, multicenter study aims to evaluate the efficacy, safety, tolerability, and pharmacokinetics of etripamil NS in this pediatric population. The study is designed in two parts, focusing first on older children aged 12 to under 18 years, then on younger children aged 6 to under 12 years if initial results support safety and efficacy. In Part 1, at least 30 patients aged 12 to under 18 years will receive a single dose of 70 mg etripamil NS, administered intranasally by study personnel during a PSVT episode. After safety and pharmacokinetic data review, at least 18 additional patients will receive a dose adjusted based on initial findings. In Part 2, at least 30 patients aged 6 to under 12 years will be treated with a dose selected by body size modeling and Part 1 data, followed by further dosing adjustments in subsequent patients. The study includes a Screening Visit, a Treatment Visit during symptomatic episodes, and a Follow-Up/End of Study Visit 1 to 5 days later. During the study, participants will be screened to confirm eligibility, including medical history and laboratory tests. At the Treatment Visit, symptoms of PSVT will be confirmed using ECG, and a vagal maneuver will be attempted before administering etripamil NS under medical supervision with continuous ECG monitoring for 1 hour. Follow-up visits will record any adverse events, vital signs, and ECG changes. The primary outcome is the percentage of patients converting to normal heart rhythm within 15 minutes after etripamil NS administration. Secondary outcomes include time to PSVT termination, need for additional medical intervention, and safety measures monitored up to 5 days post-treatment.
CONDITIONS
Brief 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 between the 5th and 85th percentiles for age and sex
- History of PSVT documented by ECG or monitoring showing AV node involvement
- Signed informed consent/assent
- Females of childbearing potential must have a negative pregnancy test and use contraception unless abstinent
- Willing and able to follow study procedures
You will not qualify if you...
- History of atrial arrhythmias not involving the AV node (e.g., atrial fibrillation, atrial flutter)
- Permanent junctional reciprocating tachycardia
- Ventricular pre-excitation such as Wolff Parkinson White syndrome
- Second- or third-degree AV block
- Sick sinus syndrome or clinically significant bradycardia (<50 bpm)
- Ventricular tachycardia
- Long QT syndrome
- Major structural heart disease or congestive heart failure symptoms
- Impaired liver function (ALT or AST >3x upper limit)
- End-stage renal disease or requiring hemodialysis
- Recent use of investigational drugs or certain antiarrhythmic medications
- Hypersensitivity to verapamil or study drug ingredients
- Significant co-morbid conditions impacting participation
- History of hyperthyroidism
- Current pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment episode with 1 hour monitoring after administration
Participants with a confirmed PSVT episode will receive a single dose of etripamil nasal spray under medical supervision with ECG monitoring.
1 treatment visit (in-person)
Duration - 1 to 5 days after treatment
Participants will have a follow-up visit 1 to 5 days after treatment to record any adverse events, vital signs, and ECG assessments.
1 follow-up visit (in-person)
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
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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