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Calcium Channel Blocker

Etripamil for Supraventricular Tachycardia (NODE-301 Trial)

Phase 3
Waitlist Available
Research Sponsored by Milestone Pharmaceuticals Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 5 hours after administration of study drug
Awards & highlights
Pivotal Trial

Summary

This trial is testing a nasal spray called etripamil that patients with a fast heart rate condition (PSVT) can use at home. The spray works by quickly calming the heart when sprayed into the nose. The study aims to see if this treatment is safe and effective for these patients.

Eligible Conditions
  • Supraventricular Tachycardia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from 10 minutes to 300 minutes after start of study drug dosing.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from 10 minutes to 300 minutes after start of study drug dosing. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The Time to Conversion of an Episode of PSVT to Sinus Rhythm (SR) After Study Drug Administration.
Secondary study objectives
Rating of Treatment Satisfaction Questionnaire for Medication (TSQM-9).
Relief of specific symptoms (i.e., heart palpitations, rapid pulse feeling, chest pain, anxiety, shortness of breath, dizziness, and fainting) potentially associated with an episode of PSVT.
Time to conversion at time points prior to, and later than, 30 minutes.
Other study objectives
The percentage of patients requiring additional medical intervention to terminate an episode of PSVT.
The repeat of key efficacy endpoints in various subgroups of interest (e.g., concomitant medications).

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

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

6Treatment groups
Experimental Treatment
Placebo Group
Group I: Part 2 & Part 3: Test dose only (etripamil 70 mg + 70 mg)Experimental Treatment1 Intervention
Repeat Test Dose of etripamil 70 mg (2X 70mg) 10 minutes apart in sinus rhythm
Group II: Part 2 & Part 3: Etripamil 70 mg with Optional Second DoseExperimental Treatment1 Intervention
Self-administration of 70 mg etripamil for a perceived episode of PSVT followed 10 minutes later by an optional second dose of 70 mg etripamil, if symptoms persisted. Participants could be enrolled in the open-label period to treat an additional PSVT episode with etripamil.
Group III: Part 1: Test dose only (etripamil 70 mg)Experimental Treatment1 Intervention
Single test dose of etripamil 70 mg in sinus rhythm
Group IV: Part 1: Etripamil 70 mg Single DoseExperimental Treatment1 Intervention
Self-administration of a single dose etripamil 70 mg for a perceived episode of PSVT.
Group V: Part 1: Placebo Single DosePlacebo Group1 Intervention
Self-administration of a single dose of placebo for a perceived episode of PSVT.
Group VI: Part 2 & Part 3: Placebo with Optional Second DosePlacebo Group1 Intervention
Self-administration of placebo for a perceived episode of PSVT followed 10 minutes later by an optional second dose of placebo, if symptoms persisted. Participants could be enrolled in the open-label period to treat an additional PSVT episode with etripamil.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Etripamil
Not yet FDA approved

Find a Location

Who is running the clinical trial?

IQVIA BiotechIndustry Sponsor
20 Previous Clinical Trials
4,638 Total Patients Enrolled
Milestone Pharmaceuticals Inc.Lead Sponsor
9 Previous Clinical Trials
2,609 Total Patients Enrolled
Medpace, Inc.Industry Sponsor
96 Previous Clinical Trials
28,774 Total Patients Enrolled
~150 spots leftby Oct 2025
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