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The NODE-202 Study (Study of Etripamil Nasal Spray in Pediatric Patients)
EU CTIS ID: 2022-500319-38-00
What this study is testing
To demonstrate the efficacy of a single intranasal (IN) dose of etripamil nasal spray (NS) in terminating a spontaneous episode of PSVT in Part 1: Patients aged 12 to <18 years, and Part 2: Patients aged 6 to <12 years.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or female patients: a) Part 1: patients 12 to <18 years of age b) 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 AV node (i.e., AVNRT or AVRT). If patient had a prior ablation for PSVT, patient must have documented evidence of PSVT post-ablation
- Signed written informed consent/assent obtained
- Females of childbearing potential (defined as any woman or adolescent who has begun menstruation) must additionally satisfy the following criteria: a) Negative pregnancy test at screening b) Adequate contraception, unless total abstinence is used. Adequate contraception must be used from the time of signed informed consent until the post-treatment follow-up visit. Acceptable methods include combined (estrogen and progestogen containing) or progestogen-only hormonal contraception, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), male or female condom with or without spermicide, cap, diaphragm or sponge with spermicide. NOTE: Patients who become a female of child-bearing potential after their screening visit must be re-assessed for these criteria before a treatment visit.
- Willing and able to comply with study procedures.
You likely can't join if
- History or presence of any of the following at the screening visit: a) 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; b) Permanent junctional reciprocating tachycardia; c) Ventricular pre-excitation (e.g., delta wave on ECG, Wolff Parkinson White syndrome); d) Second- or third-degree AV block; e) Sick sinus syndrome or clinically significant bradycardia (<50 bpm or equivalent in this patient population) on the resting ECG; f) Ventricular tachycardia; g) Long QT syndrome; h) 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 (using revised bedside Schwartz equation) 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: a) Any investigational drug within 60 days prior to study drug administration; b) 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; c) Oral amiodarone within 30 days prior to study drug administration; d) Class I or III antiarrhythmic agents (e.g., flecainide, propafenone, sotalol) within five half-lives prior to study drug administration; e) Any other drug that has a contraindication with verapamil.
- Known hypersensitivity to verapamil or to any of the excipients of the study drug
- 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
See the full eligibility criteria
Who can join
- Male or female patients: a) Part 1: patients 12 to <18 years of age b) 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 AV node (i.e., AVNRT or AVRT). If patient had a prior ablation for PSVT, patient must have documented evidence of PSVT post-ablation
- Signed written informed consent/assent obtained
- Females of childbearing potential (defined as any woman or adolescent who has begun menstruation) must additionally satisfy the following criteria: a) Negative pregnancy test at screening b) Adequate contraception, unless total abstinence is used. Adequate contraception must be used from the time of signed informed consent until the post-treatment follow-up visit. Acceptable methods include combined (estrogen and progestogen containing) or progestogen-only hormonal contraception, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), male or female condom with or without spermicide, cap, diaphragm or sponge with spermicide. NOTE: Patients who become a female of child-bearing potential after their screening visit must be re-assessed for these criteria before a treatment visit.
- Willing and able to comply with study procedures.
What rules you out
- History or presence of any of the following at the screening visit: a) 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; b) Permanent junctional reciprocating tachycardia; c) Ventricular pre-excitation (e.g., delta wave on ECG, Wolff Parkinson White syndrome); d) Second- or third-degree AV block; e) Sick sinus syndrome or clinically significant bradycardia (<50 bpm or equivalent in this patient population) on the resting ECG; f) Ventricular tachycardia; g) Long QT syndrome; h) 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 (using revised bedside Schwartz equation) 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: a) Any investigational drug within 60 days prior to study drug administration; b) 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; c) Oral amiodarone within 30 days prior to study drug administration; d) Class I or III antiarrhythmic agents (e.g., flecainide, propafenone, sotalol) within five half-lives prior to study drug administration; e) Any other drug that has a contraindication with verapamil.
- Known hypersensitivity to verapamil or to any of the excipients of the study drug
- 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
- History of hyperthyroidism
- Current pregnancy or breastfeeding
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.