Etripamil Nasal Spray for Rapid Heartbeat

Phase 2

Recruiting

Research Sponsored by Milestone Pharmaceuticals Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Part 1: patients 12 to <18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 minutes after administration of etripamil ns

Awards & highlights

No Placebo-Only Group

Summary

This trial is to test a nasal spray as a treatment for paroxysmal supraventricular tachycardia in pediatric patients, assessing safety, efficacy and how it is absorbed.

Who is the study for?

The NODE-202 study is for kids and teens with a rapid heartbeat condition called PSVT. Participants aged 12 to less than 18 can join Part 1, while those aged 6 to less than 12 can join Part 2. They should have a BMI within the normal range for their age and sex, documented history of PSVT, and if post-ablation, evidence of PSVT recurrence. A negative pregnancy test and agreement to use contraception are required.

What is being tested?

This trial tests Etripamil Nasal Spray (NS) in two age groups: first in older children (Part 1), then younger ones (Part 2). It's an open-label study where everyone gets the drug. The dose is based on body size and previous results from older participants. Researchers will check how well it works, its safety, tolerability, and how the body processes it.

What are the potential side effects?

While specific side effects aren't listed here, common concerns with nasal sprays may include nasal discomfort or irritation, sneezing fits or nosebleeds. Since Etripamil affects heart rhythm, monitoring for heart-related side effects like changes in blood pressure or unusual heartbeats would be important.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a history of rapid heartbeats confirmed by a heart monitor.

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I am between 12 and 17 years old.

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I am between 6 and 11 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 minutes after administration of etripamil ns

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 minutes after administration of etripamil ns

This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 minutes after administration of etripamil ns for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Efficacy: The percentage of patients converting to sinus rhythm (SR) in the first 15 minutes after administration of etripamil NS.

Secondary study objectives

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

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

Safety: Frequency of AEs

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Other study objectives

Pharmacokinetic analysis of MSP-2030 (inactive metabolite): Area under the concentration-time curve from dosing (time 0) to time infinity (AUC0-inf).

Pharmacokinetic analysis of MSP-2030 (inactive metabolite): Area under the concentration-time curve from dosing (time 0) to time t (AUC0-t).

Pharmacokinetic analysis of MSP-2030 (inactive metabolite): Elimination rate constant (Kel).

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