The NODE-202 Study (Study of Etripamil Nasal Spray in Pediatric Patients)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age6-17
SponsorMilestone Pharmaceuticals Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Etripamil NS
DrugPart 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.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Etripamil NS 70mgExperimental treatment 1 intervention
Trial outcomes
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
Time frame
15 minutes after administration of etripamil NSSecondary outcomes
1
Efficacy: Time to termination of the PSVT episode and conversion to SR
Time measured from time of dosing to time of conversion of PSVT to SR that is maintained for at least 30 seconds
Time frame
60 minutes after administration of etripamil NS2
Efficacy: Percentage of patients requiring additional medical intervention treatment for the PSVT episode in the first 15 minutes after study drug administration.
Medical intervention is defined as an administered drug or procedure to treat PSVT
Time frame
15 minutes after administration of etripamil NS3
Safety: Frequency of AEs
Adverse Events (AEs) defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related
Time frame
Until 5 days after administration of etripamil NS4
Safety: Local (administration site) tolerability
Local tolerability defined as frequency of adverse events related to nasal spray site administration
Time frame
Until 5 days after administration of etripamil NSOther outcomes
1
Pharmacokinetic analysis of etripamil: Maximum plasma concentration (Cmax)
Maximum plasma concentration (Cmax) in ng/mL of etripamil assessed from PK analysis of plasma samples within 1 hour of dosing.
Time frame
Within 1 hour after administration of etripamil NS2
Pharmacokinetic analysis of etripamil: Area under the concentration-time curve from dosing (time 0) to time t (AUC0-t).
Area under the concentration-time curve from dosing (time 0) to time t (AUC0-t) in min\*ng/mL of etripamil assessed from PK analysis of plasma samples within 1 hour of dosing.
Time frame
Within 1 hour after administration of etripamil NS3
Pharmacokinetic analysis of etripamil: Area under the concentration-time curve from dosing (time 0) to time infinity (AUC0-inf).
Area under the concentration-time curve from dosing (time 0) to time infinity (AUC0-inf) in min\*ng/mL of etripamil assessed from PK analysis of plasma samples within 1 hour of dosing.
Time frame
Within 1 hour after administration of etripamil NS4
Pharmacokinetic analysis of etripamil: Elimination rate constant (Kel)
Elimination rate constant (Kel) in 1/minutes of etripamil assessed from PK analysis of plasma samples within 1 hour of dosing.
Time frame
Within 1 hour after administration of etripamil NSSponsors and contacts
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Source ClinicalTrials.gov