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Calcium Channel Blocker

Etripamil for Supraventricular Tachycardia

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 30 minutes of start of study drug dosing.
Awards & highlights

Study Summary

This trial is a study to see if a drug is effective and safe for people with a heart condition who have episodes of irregular heartbeats at home. The study will follow patients for six months to see if the drug is effective in treating the condition.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The time to conversion of an episode of PSVT to sinus rhythm (SR) after study drug administration.
Secondary outcome measures
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 outcome measures
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

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Etripamil 70 mg with Optional Second DoseExperimental Treatment1 Intervention
Dosing regimen that permits a second dose of etripamil 70 mg
Group II: Etripamil 70 mg Single DoseExperimental Treatment1 Intervention
Self- administration of a single dose of 70 mg of etripamil.
Group III: Placebo Single DosePlacebo Group1 Intervention
Self- administration of a single dose of placebo.
Group IV: Placebo with Optional Second DosePlacebo Group2 Interventions
Dosing regimen that permits a second dose of placebo.
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
18 Previous Clinical Trials
4,160 Total Patients Enrolled
Milestone Pharmaceuticals Inc.Lead Sponsor
9 Previous Clinical Trials
2,611 Total Patients Enrolled
Medpace, Inc.Industry Sponsor
94 Previous Clinical Trials
28,867 Total Patients Enrolled

Frequently Asked Questions

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

Are there any other similar trials to this one?

"Etripamil has been under investigation since 2018. The first clinical trial, conducted that same year, was sponsored by Medpace, Inc. After the 701-person Phase 1 trial, the medication received approval for Phase 3 testing. Now, 4 years later, there are 4 active trials involving Etripamil across 180 cities and 21 countries."

Answered by AI

What has been the most dangerous side effect of Etripamil to date?

"Etripamil is considered safe based on our team's assessment. This is a phase 3 trial, which means that while there is evidence of efficacy, there is also extensive data supporting the safety of the medication."

Answered by AI

How many people are you recruiting for this experiment?

"As of October 11th, 2022, this clinical trial is no longer seeking participants. It was initially posted on June 18th, 2018. However, if you are still interested in participating in medical research, there are presently 125 clinical trials actively looking for patients with tachycardia and 4 studies for Etripamil actively admitting participants."

Answered by AI

How many different sites are conducting this clinical trial?

"As of right now, 72 patients have enrolled in this study at various locations including CSSS du Sud de Lanaudiere - Hopital Pierre Le Gardeur in Terrebonne, CardioVasc HR in Saint-Jean-sur-Richelieu, and Prisma Health Midlands in Columbia."

Answered by AI

Would it be possible to enroll in this research project at this time?

"The recruitment period for this particular clinical trial has ended. However, it is worth noting that there are currently 125 tachycardia studies and 4 Etripamil trials that are actively recruiting patients."

Answered by AI

Could you please list other research projects that have used Etripamil?

"Currently, there are four active clinical trials researching etripamil. Three of those studies are in phase three. Although the majority of studies for etripamil are based in Hershey, Pennsylvania, there are 392 locations running trials for this treatment across the United States."

Answered by AI

Who else is applying?

What state do they live in?
Texas
Ohio
How old are they?
18 - 65
What site did they apply to?
Hatton Institute for Research & Education, Trihealth, Inc. - cardiology
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Efficacy and Safety of Etripamil for the Termination of Spontaneous Paroxymal Supraventricular Tachycardia (PSVT). NODE 301 [Part 1 and Part 2 (RAPID Study)]
2018. "Efficacy and Safety of Etripamil for the Termination of Spontaneous Paroxymal Supraventricular Tachycardia (PSVT). NODE 301 [Part 1 and Part 2 (RAPID Study)]". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03464019.
~109 spots leftby Apr 2025
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