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Calcium Channel Blocker

Etripamil NS 70mg for Supraventricular Tachycardia

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

Study 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.Check my eligibility
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.See study design
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.
Select...
I am between 12 and 17 years old.
Select...
I am between 6 and 11 years old.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy: The percentage of patients converting to sinus rhythm (SR) in the first 15 minutes after administration of etripamil NS.
Secondary outcome measures
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
+3 more
Other outcome measures
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).
+9 more

Side effects data

From 2016 Phase 2 trial • 199 Patients • NCT02296190
45%
Nasal congestion
35%
Nasal Discomfort
35%
Throat Irritation
20%
Oropharyngeal pain
15%
Headache
10%
Cough
10%
Vomiting
5%
Catheter site bruise
5%
Acute Respiratory Failure
5%
Oral Discomfort
5%
Urinary Retention
5%
Bundle Branch Block Right
5%
Catheter site haematoma
5%
Rhinorrhea
5%
Increased lacrimation
5%
Nausea
5%
Hypotension
5%
Paraesthesia
5%
Back Pain
5%
Dysgeusia
5%
Facial Flushing
5%
Procedural Pain
5%
Cerebrovascular disorder
5%
Sedation
5%
Vision Blurred
5%
Visual Impairment
5%
Constipation
5%
Petechiae
100%
80%
60%
40%
20%
0%
Study treatment Arm
Etripamil_105 mg
Etripamil_70 mg
Placebo
Etripamil_140 mg
Open Label Etripamil 70 mg
Etripamil_35 mg

Trial Design

1Treatment groups
Experimental Treatment
Group I: Etripamil NS 70mgExperimental Treatment1 Intervention
Patients will be administered by study site personnel
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Etripamil NS
2019
Completed Phase 3
~1120

Find a Location

Who is running the clinical trial?

Milestone Pharmaceuticals Inc.Lead Sponsor
9 Previous Clinical Trials
3,299 Total Patients Enrolled
David Bharucha, MDStudy DirectorMilestone Pharmaceuticals
1 Previous Clinical Trials
748 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it feasible for people aged 45 and above to partake in this experiment?

"This clinical trial has established the age range for participants to be between 6 and 18 years old."

Answered by AI

What is the cap for participants in this investigation?

"Affirmative, according to clinicaltrials.gov the trial is actively recruiting participants at this time. The study was first posted on December 11th 2023 and has since received an update that same month. 60 individuals are required from 1 specific medical centre for successful completion of the research project."

Answered by AI

Is it currently possible to apply for this research project?

"Affirmative. Clinicaltrials.gov has reported that this experiment is actively recruiting participants, first posted on December 11th 2023 and most recently updated December 12th 2023. 60 patients are needed across 1 medical facility to meet the criteria of the trial."

Answered by AI

Has the US Food and Drug Administration sanctioned Etripamil NS 70mg?

"Supported by evidence from Phase 2 trials, our team has assigned Etripamil NS 70mg a safety score of two on the scale of one to three. There is currently no data that suggests this medication's efficacy in treating any conditions."

Answered by AI

Am I allowed to participate in this experiment?

"This clinical trial will enrol 60 individuals between the ages of 6 and 18 that have been diagnosed with supraventricular tachycardia (SVT). All applicants must meet a set of rigid criteria, namely: male or female gender; age bracket within 12 to <18 years old for part 1 and 6 to <12 years old for part 2; body mass index (BMI) in range from 5th to 85th percentile based on sex and age; history of SVT evidenced by electrocardiogram or other monitoring device such as Holter monitor/event recorder revealing AV node-related disorder like Atrioventricular nodal"

Answered by AI
Recent research and studies
clinicaltrials.govStudy
The NODE-202 Study (Study of Etripamil Nasal Spray in Pediatric Patients)
2023. "The NODE-202 Study (Study of Etripamil Nasal Spray in Pediatric Patients)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05763953.
~40 spots leftby Jun 2027
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