The NODE-202 Study (Study of Etripamil Nasal Spray in Pediatric Patients) (NCT05763953) | Clinical Trial Compass
RecruitingPhase 2
The NODE-202 Study (Study of Etripamil Nasal Spray in Pediatric Patients)
United States60 participantsStarted 2023-12-11
Plain-language 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.
Who can participate
Age range6 Years – 17 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕
What they're measuring
1
Efficacy: The percentage of patients converting to sinus rhythm (SR) in the first 15 minutes after administration of etripamil NS.
Timeframe: 15 minutes after administration of etripamil NS
. 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