NCT04952610

Brief Summary

This Open Label Extension study will enable eligible patients with Paroxysmal Supraventricular Tachycardia (PSVT) who have previously participated in a Milestone Pharmaceuticals clinical trial of etripamil NS for PSVT, to access continued treatment with etripamil NS, Patients who experienced any significant safety issues during participation period in a previous clinical trial of etripamil NS, as per Investigator's assessment , are excluded. This study will be conducted by Investigators who previously participated in a Milestone Pharmaceuticals clinical trial and are trained on the use of etripamil NS.

Trial Health

58
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2021

Typical duration for phase_3

Geographic Reach
2 countries

23 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 7, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

December 13, 2021

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

4.4 years

First QC Date

April 23, 2021

Last Update Submit

March 31, 2026

Conditions

Paroxysmal Supraventricular Tachycardia

Outcome Measures

Primary Outcomes (1)

  • The safety of self-administered etripamil Nasal Spray (NS) for treatment of episodes of PSVT outside of the clinical setting as assessed by patient-reported adverse events.

    Up to 3 years

Study Arms (1)

Etripamil NS 70 mg

EXPERIMENTAL

Self- administration of a dose of 70 mg of etripamil. Patients will be provided with a maximum of 4 pre-filled devices at a time. If the symptoms of PSVT persist 10 minutes after the first dose of etripamil NS 70 mg, a second dose of etripamil NS 70 mg can be self-administered by the patient. A second dose of etripamil NS 70 mg should be taken not earlier than 10, and not later than 15 minutes after the first dose.

Drug: Etripamil NS 70 mgDevice: Aptar Pharma Nasal Spray Bidose System

Interventions

Etripamil NS 70 mgDRUG

Etripamil will be administered via the Aptar Pharma Nasal Spray Bidose System.

Etripamil NS 70 mg
Aptar Pharma Nasal Spray Bidose SystemDEVICE

Aptar Pharma Nasal Spray Bidose System will be supplied as prefilled devices packaged into child-resistant boxes with instructions for use provided in the study drug box.

Etripamil NS 70 mg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A patient will be eligible for study participation if they meet all of the following criteria:
  • Has participated in a Milestone Pharmaceuticals Inc. clinical research trial of etripamil NS for the treatment of PSVT (NODE-301 Part1, RAPID (NODE-301 Part 2), NODE-302, or NODE-303.
  • Has signed the MSP-2017-1278 written informed consent;
  • Women of childbearing potential who are sexually active with a male partner who is not surgically sterile (i.e., vasectomy) must be willing to use at least 1 form of highly effective contraception from the time of signed informed consent until 7 days after the last administration of etripamil NS and must be willing to discontinue from the study should they become or plan to become pregnant.
  • The following categories define females who are not considered to be of childbearing potential:
  • Postmenopausal females, defined as having amenorrhea for at least 12 months without an alternative medical cause; or
  • Premenopausal females with 1 of the following:
  • Documented hysterectomy; or
  • Documented bilateral salpingectomy; or
  • Documented bilateral oophorectomy; or
  • All females who do not meet at least one of the above criteria are considered to be of childbearing potential
  • Willing and able to comply with Investigator instructions on etripamil NS use and study requirements.

You may not qualify if:

  • A patient will be excluded from the study if they meet any of the following criteria:
  • History of allergic reaction to verapamil, etripamil, or any of the investigational medical components;
  • Current chronic therapy with digoxin, or any Class I or III antiarrhythmic drug. Patients may be eligible if these drugs are stopped at least five half-lives before enrollment. The only exception is oral amiodarone which must be stopped 30 days before enrollment;
  • History of ventricular pre-excitation, e.g., delta waves, Wolff-Parkinson-White syndrome;
  • History of a second- or third-degree atrioventricular block;
  • History of sick sinus syndrome and marked bradycardia (≤40 beats/minute);
  • History or evidence of severe ventricular arrhythmia (e.g. torsades de points, ventricular fibrillation, or sustained ventricular tachycardia)
  • Symptoms of congestive heart failure New York Heart Association Class II to IV;
  • Significant physical or psychiatric condition including alcoholism or drug abuse, which, in the opinion of the Investigator, could jeopardize the safety of the patient, or impede the patient's capacity to follow the study requirements;
  • Syncope due to an arrhythmic etiology or unexplained syncope during or after participation in an etripamil clinical research trial;
  • Is pregnant, breastfeeding, or is planning to become pregnant during the study;
  • History of acute coronary syndrome (without successful revascularization) or stroke within 6 months of enrollment;
  • Evidence of symptoms of hypotension within 24 hours following previous administration of etripamil, per Investigator's opinion.
  • Has experienced a significant safety issue related to study drug administration during participation in a previous etripamil study for PSVT, per the Investigator's opinion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

Site # 0160

Little Rock, Arkansas, 72205, United States

Location

Site # 1023

Vista, California, 92083, United States

Location

Site # 1083

West Hills, California, 91307, United States

Location

Site # 0102

Atlanta, Georgia, 30309, United States

Location

Site # 0137

Macon, Georgia, 31201, United States

Location

Site # 1115

Coeur d'Alene, Idaho, 83814, United States

Location

Site # 0149

Fort Wayne, Indiana, 46845, United States

Location

Site # 1025

West Des Moines, Iowa, 50266, United States

Location

Site # 1007

Salisbury, Maryland, 21801, United States

Location

Site # 0166

Lansing, Michigan, 48912, United States

Location

Site # 0114

New York, New York, 10065, United States

Location

Site # 1024

Canton, Ohio, 44710, United States

Location

Site # 0110

Toledo, Ohio, 43606-, United States

Location

Site # 1123

Corvallis, Oregon, 97330, United States

Location

Site # 0105

Yardley, Pennsylvania, 19067, United States

Location

Site # 0122

Rapid City, South Dakota, 57701, United States

Location

Site # 1047

Austin, Texas, 78723, United States

Location

Site # 0213

Victoria, British Columbia, V8T 1Z4, Canada

Location

Site # 0210

Halifax, Nova Scotia, B3H 3A7, Canada

Location

Site # 2006

Oshawa, Ontario, L1J 2K1, Canada

Location

Site # 0204

Toronto, Ontario, M5B 1W8, Canada

Location

Site # 0203

Montreal, Quebec, H1T 1C8, Canada

Location

Site # 0205

Montreal, Quebec, H2X 0A9, Canada

Location

MeSH Terms

Conditions

Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

TachycardiaArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: This is a multicenter study to enable patients with PVST to have continued access of etripamil NS. The study will only include patients who have participated in a Milestone Pharmaceuticals Inc. approved clinical research trial (NODE-301 Part 1, RAPID Study (NODE-301 Part 2), NODE-302, or NODE-303) of etripamil NS for PSVT. Patients who experienced any significant safety issues during participation in a previous study, as per Investigator's assessment, are excluded. This study is planned to continue until etripamil NS is commercially available for patients with PSVT or the study is terminated by the Sponsor for any reason.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2021

First Posted

July 7, 2021

Study Start

December 13, 2021

Primary Completion

April 30, 2026

Study Completion

April 30, 2026

Last Updated

April 1, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(17)CA(6)