The NODE-202 Study (Study of Etripamil Nasal Spray in Pediatric Patients)

NCT05763953 | Recruiting Phase 2 FDA Drug

• 1 other identifier: MSP-2017-1265
• Study Type: interventional
• Target: 60
• Locations: 4 countries
• Sites: 10

Brief 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

Paroxysmal Supraventricular Tachycardia

Keywords

PSVT

Outcome Measures

Primary Outcomes (1)

• Efficacy: The percentage of patients converting to sinus rhythm (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

  15 minutes after administration of etripamil NS

Secondary Outcomes (6)

• Efficacy: Time to termination of the PSVT episode and conversion to SR

  60 minutes after administration of etripamil NS

• Efficacy: Percentage of patients requiring additional medical intervention treatment for the PSVT episode in the first 15 minutes after study drug administration.

  15 minutes after administration of etripamil NS

• Safety: Frequency of AEs

  Until 5 days after administration of etripamil NS

• Safety: Local (administration site) tolerability

  Until 5 days after administration of etripamil NS

• Safety: Post-dose changes in vital signs (Hearth rate (HR))

  Until 5 days after administration of etripamil NS

Other Outcomes (12)

• Pharmacokinetic analysis of etripamil: Maximum plasma concentration (Cmax)

  Within 1 hour after administration of etripamil NS

• Pharmacokinetic analysis of etripamil: Area under the concentration-time curve from dosing (time 0) to time t (AUC0-t).

  Within 1 hour after administration of etripamil NS

• Pharmacokinetic analysis of etripamil: Area under the concentration-time curve from dosing (time 0) to time infinity (AUC0-inf).

  Within 1 hour after administration of etripamil NS

Study Arms (1)

Etripamil NS 70mg

EXPERIMENTAL

Patients will be administered by study site personnel

Drug: Etripamil NS

Interventions

Etripamil NS DRUG

Part 1A: At least 12 patients will be administered with Etripamil NS (35 mg/100 μL per nostril) at a dose of 70 mg. Part 1B: At least 18 following patients will be administered with Etripamil NS at a dose determined by analysis of data generated from Part 1A. Part 2A: At least 12 patients will be administered with Etripamil NS at a dose selected based on appropriate body size-based modeling using PK assessments, as well as safety/tolerability, and efficacy data collected in Part 1. Part 2B: At least 18 following patients will be administered with Etripamil NS at a dose determined by analysis of data generated from Part 2A.

Etripamil NS 70mg

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients will be eligible for study participation if they meet all of the following criteria at screening:
• Male or female patients
• Part 1: patients 12 to \<18 years of age
• Part 2: patients 6 to \<12 years of age
• Body mass index (BMI) between the 5th and the 85th percentiles interpreted relative sex and age
• History of PSVT documented by ECG or other monitoring modality (e.g., Holter monitor, event recorder) showing SVT involving the Atrioventricular (AV) node (i.e., Atrioventricular nodal reentry tachycardia (AVNRT) or Atrioventricular reentrant tachycardia (AVRT)). If patient had a prior ablation for PSVT, patient must have documented evidence of PSVT post-ablation
• Signed written informed consent/assent obtained
• Per Investigator's decision, females of childbearing potential (defined as any woman or adolescent who has begun menstruation) must additionally satisfy the following criteria:
• Negative pregnancy test at screening
• Adequate contraception, unless total abstinence is used
• Willing and able to comply with study procedures.

You may not qualify if:

• Patients will be excluded from the study if they meet any of the following criteria:
• History or presence of any of the following at the screening visit:
• Patients with a history of atrial arrhythmia that does not involve the AV node as part of the tachycardia circuit (e.g., atrial fibrillation, atrial flutter, atrial tachycardia) are not eligible
• Permanent junctional reciprocating tachycardia
• Ventricular pre-excitation (e.g., delta wave on ECG, Wolff Parkinson White syndrome)
• Second- or third-degree AV block
• Sick sinus syndrome or clinically significant bradycardia (\<50 bpm or equivalent in this patient population) on the resting ECG
• Ventricular tachycardia
• Long QT syndrome
• Major structural heart disease (e.g., Ebstein's anomaly, corrected congenital heart disease) or symptoms of congestive heart failure (New York Heart Association class II to IV).
• Evidence of impaired liver function (alanine aminotransferase \[ALT\] and/or aspartate aminotransferase \[AST\] \>3 x upper limit of normal for age and gender) at the Screening Visit
• Evidence of End-Stage Renal Disease as determined by an estimated glomerular filtration rate assessed at the Screening Visit of \<15 mL/min/1.73m2, or requiring hemodialysis;
• Treatment with any of the following that cannot or will not be discontinued during study participation:
• Any investigational drug within 60 days prior to study drug administration
• IV beta-adrenergic blocking drugs (e.g., propranolol, esmolol), calcium channel blocking drugs (e.g., verapamil, diltiazem) or amiodarone within 24 hours prior to study drug administration

Sponsors & Collaborators

• Milestone Pharmaceuticals Inc.: lead

Study Sites (10)

Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States

RECRUITING

Advocate Children's Hospital

Oak Lawn, Illinois, 60453, United States

NOT YET RECRUITING

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

NOT YET RECRUITING

Oregon Health and Science University

Portland, Oregon, 97239, United States

RECRUITING

Le Bonheur Children's Hospital

Memphis, Tennessee, 38103, United States

NOT YET RECRUITING

Baylor College of Medicine

Houston, Texas, 77030, United States

NOT YET RECRUITING

The University of British Columbia

Vancouver, V6H3V4, Canada

NOT YET RECRUITING

Universitätsmedizin Göttingen, Klinik für Pädiatrische Kardiologie, Intensivmedizin und Neonatologie

Göttingen, 37075, Germany

NOT YET RECRUITING

Hospital Sant Joan de Déu

Barcelona, 08950, Spain

NOT YET RECRUITING

Hospital Infantil Universitario La Paz

Madrid, 28046, Spain

RECRUITING

MeSH Terms

Conditions

Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• David Bharucha, MD

  Milestone Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Cameron Szakacs, PhD

CONTACT

704-807-6520; cszakacs@milestonepharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2023
• First Posted: March 10, 2023
• Study Start: December 11, 2023
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: August 1, 2025

Record last verified: 2025-07

Locations

US (6); ES (2); DE (1); CA (1)