RECRUITING

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

Conditions

Paroxysmal Supraventricular Tachycardia PSVT

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-12-11

Study Completion:2027-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05763953

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years to 17 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion Criteria
1. Male or female patients 1. Part 1: patients 12 to \<18 years of age 2. Part 2: patients 6 to \<12 years of age 2. Body mass index (BMI) between the 5th and the 85th percentiles interpreted relative sex and age 3. 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 4. Signed written informed consent/assent obtained 5. Per Investigator's decision, females of childbearing potential (defined as any woman or adolescent who has begun menstruation) must additionally satisfy the following criteria: 1. Negative pregnancy test at screening 2. Adequate contraception, unless total abstinence is used 6. Willing and able to comply with study procedures.	1. History or presence of any of the following at the screening visit: 1. 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 2. Permanent junctional reciprocating tachycardia 3. Ventricular pre-excitation (e.g., delta wave on ECG, Wolff Parkinson White syndrome) 4. Second- or third-degree AV block 5. Sick sinus syndrome or clinically significant bradycardia (\<50 bpm or equivalent in this patient population) on the resting ECG 6. Ventricular tachycardia 7. Long QT syndrome 8. 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). 2. 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 3. 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; 4. Treatment with any of the following that cannot or will not be discontinued during study participation: 1. Any investigational drug within 60 days prior to study drug administration 2. 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 3. Oral amiodarone within 30 days prior to study drug administration 4. Class I or III antiarrhythmic agents (e.g., flecainide, propafenone, sotalol) within five half-lives prior to study drug administration 5. Any other drug that has a contraindication with verapamil 5. Known hypersensitivity to verapamil or to any of the excipients of the study drug 6. Any other significant co-morbid condition that may have a negative impact on the patient's participation in the study or likely to result in non-compliance 7. History of hyperthyroidism 8. Current pregnancy or breastfeeding

Inclusion Criteria

Exclusion Criteria

1. Male or female patients
1. Part 1: patients 12 to \<18 years of age
2. Part 2: patients 6 to \<12 years of age
2. Body mass index (BMI) between the 5th and the 85th percentiles interpreted relative sex and age
3. 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
4. Signed written informed consent/assent obtained
5. Per Investigator's decision, females of childbearing potential (defined as any woman or adolescent who has begun menstruation) must additionally satisfy the following criteria:
1. Negative pregnancy test at screening
2. Adequate contraception, unless total abstinence is used
6. Willing and able to comply with study procedures.

1. History or presence of any of the following at the screening visit:
1. 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
2. Permanent junctional reciprocating tachycardia
3. Ventricular pre-excitation (e.g., delta wave on ECG, Wolff Parkinson White syndrome)
4. Second- or third-degree AV block
5. Sick sinus syndrome or clinically significant bradycardia (\<50 bpm or equivalent in this patient population) on the resting ECG
6. Ventricular tachycardia
7. Long QT syndrome
8. 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).
2. 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
3. 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;
4. Treatment with any of the following that cannot or will not be discontinued during study participation:
1. Any investigational drug within 60 days prior to study drug administration
2. 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
3. Oral amiodarone within 30 days prior to study drug administration
4. Class I or III antiarrhythmic agents (e.g., flecainide, propafenone, sotalol) within five half-lives prior to study drug administration
5. Any other drug that has a contraindication with verapamil
5. Known hypersensitivity to verapamil or to any of the excipients of the study drug
6. Any other significant co-morbid condition that may have a negative impact on the patient's participation in the study or likely to result in non-compliance
7. History of hyperthyroidism
8. Current pregnancy or breastfeeding

Contacts and Locations

Study Contact

Cameron Szakacs, PhD

CONTACT

704-807-6520

cszakacs@milestonepharma.com

Principal Investigator

David Bharucha, MD

STUDY_DIRECTOR

Milestone Pharmaceuticals

Study Locations (Sites)

Phoenix Children's Hospital

Phoenix, Arizona, 85016

United States

Advocate Children's Hospital

Oak Lawn, Illinois, 60453

United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229

United States

Oregon Health and Science University

Portland, Oregon, 97239

United States

Le Bonheur Children's Hospital

Memphis, Tennessee, 38103

United States

Baylor College of Medicine

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Milestone Pharmaceuticals Inc.

David Bharucha, MD, STUDY_DIRECTOR, Milestone Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-11

Study Completion Date2027-06-30

Study Record Updates

Study Start Date2023-12-11

Study Completion Date2027-06-30

Terms related to this study

Keywords Provided by Researchers

PSVT

Additional Relevant MeSH Terms

Paroxysmal Supraventricular Tachycardia