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Paroxysmal Supraventricular TachycardiaPhase 3NCT03635996

Safety Study of Intranasal Etripamil for the Termination of Spontaneous Episodes of Paroxysmal Supraventricular Tachycardia (PSVT). NODE-302

A Phase 3 study testing Etripamil NS 70 mg and Aptar Pharma Nasal Spray Bidose System in people with Paroxysmal Supraventricular Tachycardia, run by Milestone Pharmaceuticals Inc. at 34 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The primary objective of this study is to evaluate the safety of etripamil nasal spray (NS) 70 mg when self-administered by patients with an episode of Paroxysmal Supraventricular Tachycardia in an outpatient setting (i.e., without medical supervision). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Paroxysmal Supraventricular Tachycardia
What is being tested?
Etripamil NS 70 mg and Aptar Pharma Nasal Spray Bidose System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
169 participants
Where
34 sitesin 2 countries
Study dates
10 Dec 2018to 13 Nov 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients who meet all of the following criteria will be eligible to participate in the study:
  • Male or female patients at least 18 years of age;
  • Signed the NODE-302 written informed consent;
  • Previously randomized in the NODE-301 study:
  • Received the study drug to treat symptoms the patient believed were consistent with an episode of PSVT during the NODE-301 study, irrespective of the study drug efficacy; OR
  • Did not experience an episode of PSVT or did not use the study drug at the time of the NODE-301 study completion;
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  • Willing and able to comply with all aspects of the study;
  • Females of childbearing potential who are sexually active must agree to use an approved highly effective form of contraception from the time of signed informed consent until 30 days after the last administration of study drug. Females of childbearing potential should have a negative urine pregnancy test result at the Qualification Visit and at the Follow-up Visit(s), and must use an approved form of contraception between the 2 visits. Approved forms of contraception include hormonal intrauterine devices and hormonal contraceptives (oral birth control pills, Depo Provera®, patch, or other injectables) together with supplementary double barrier methods, such as condoms or diaphragms with spermicidal gel or foam;
  • The following categories define females who are NOT considered to be of childbearing potential:
  • Premenopausal females with 1 of the following:
  • Documented hysterectomy,
  • Documented bilateral salpingectomy, or
  • Documented bilateral oophorectomy, or
  • Postmenopausal females, defined as having amenorrhea for at least 12 months without an alternative medical cause; and
  • Male patients, except those who are surgically sterile, must use an approved highly effective form of contraception during the 3 days after study drug administration.

Who cannot join

  • Patients who meet any of the following criteria will be excluded from participation in the study, including but not limited to:
  • Evidence of new severe arrhythmia discovered since the NODE-301 Test Dose Randomization Visit, including those reported on the Cardiac Monitoring System (CMS) report of the outpatient PSVT event treated with the study drug in the NODE 301 study:
  • Third-degree Atrioventricular (AV) block, Mobitz II second-degree AV block, or Wenckebach with bradycardia ≤40 bpm; e. Significant symptomatic sinus bradycardia heart rate (HR) ≤40 bpm or sinus pauses (≥3 seconds); f. Any significant ventricular arrhythmia (premature ventricular beats and couplets [>6 premature ventricular contractions per 45 seconds electrocardiogram (ECG)] are considered significant); or g. Atrial fibrillation (event lasting longer than 30 seconds);
  • Any drug-related or procedure-related serious adverse event during the NODE-301 study;
  • Any severe adverse event (AE) in the NODE-301 study that was severe enough to preclude administration of etripamil NS 70 mg in the NODE-302 study;
  • Any new drug prescribed after the end of the patient's participation in the NODE-301 study that could lower blood pressure or decrease AV node conduction;
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  • Systolic blood pressure <90 mmHg after a 5-minute rest in sitting position at the NODE-302 Qualification Visit;
  • Any symptoms consistent with clinically severe hypotension such as presyncope, medically significant lightheadedness, syncope, nausea, or vomiting;
  • New therapy with digoxin, amiodarone, or any Class I or III antiarrhythmic drug added after the end of the patient's participation in the NODE-301 study;
  • New evidence of ventricular pre-excitation (e.g., delta waves, short PR interval, Wolff Parkinson-White syndrome) on the ECG since randomization in the NODE-301 study;
  • New symptoms of congestive heart failure defined by the New York Heart Association Class II to IV since randomization in the NODE-301 study;
  • New stroke since randomization in the NODE-301 study;
  • New evidence of a significant physical or psychiatric condition including 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 procedures since randomization in the NODE-301 study;
  • New syncope since randomization in the NODE-301 study, especially if observed during the monitoring of the event treated in the NODE-301 study;
  • New evidence of hepatic dysfunction defined as alanine aminotransferase or aspartate aminotransferase >3 × the upper limit of normal (ULN) or total bilirubin >2 × ULN, unless due to Gilbert syndrome observed at the NODE-302 Qualification Visit;
  • New evidence of renal dysfunction as determined by an estimated glomerular filtration rate assessed at the NODE-302 Qualification Visit as follows:
  • <60 mL/min/1.73 m2 for patients <60 years of age,
  • <40 mL/min/1.73 m2 for patients ≥60 and <70 years of age, or
  • <35 mL/min/1.73 m2 for patients ≥70 years of age;
  • Participation in any investigational drug or device study or the use of any investigational drug or device since the Final Study Visit in the NODE-301 study.
  • Withdrawal Criteria
  • Patient participation in this clinical study may be discontinued for any of the following reasons:
  • The patient withdraws consent or requests discontinuation from the study for any reason;
  • The patient took the study drug in both the NODE-301 and the NODE-302 studies for symptoms not associated with an episode of PSVT;
  • Occurrence of any medical condition, AE, or circumstance that exposes the patient to substantial risk and/or does not allow the patient to adhere to the requirements of the protocol;
  • Requirement of a prohibited concomitant medication and/or change in the use of chronic therapies, such as concomitant beta-blockers, calcium channel blockers, and medications that can lower blood pressure;
  • Patient failure to comply with protocol requirements or study-related procedures;
  • Termination of the study by Milestone or a regulatory authority; or
  • The patient self-administered a total of 11 doses of etripamil Nasal Spray 70 mg in the NODE-302 study.
  • Patients who withdraw from the study after taking etripamil Nasal Spray 70 mg and had a Follow-up Visit will be required to undergo an Early Termination Visit.
  • Patients who withdraw from the study and did not take etripamil Nasal Spray 70 mg will be required to undergo an Early Termination Visit.
  • Patients who withdraw after taking the study drug but did not have a Follow-up Visit will be required to undergo a Final Study Visit.

Trial locations and contacts

34 sites in 2 countries.

34 sites in 2 countries

United States22 sites

  • Piedmont Heart Institute

    Atlanta, Georgia, 30309

  • MedStar Health Research Institute

    Baltimore, Maryland, 21237

  • Trinity Medical WNY, PC

    Buffalo, New York, 14215

  • The Presbyterian Hospital DBA Novant Health Heart and Vascular Institute

    Charlotte, North Carolina, 28204

  • Columbus Regional Research Institute

    Columbus, Georgia, 31904

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Baptist Health Ambulatory Services

    Jacksonville, Florida, 32207

  • Mayo Clinic - Jacksonville

    Jacksonville, Florida, 32224

  • Arkansas Cardiology

    Little Rock, Arkansas, 72205

  • South Denver Cardiology Associates, P.C

    Littleton, Colorado, 80120

  • Los Alamitos Cardiovascular

    Los Alamitos, California, 90720

  • Georgia Arrythmia Consultants&Research Institute

    Macon, Georgia, 312012

  • Atlantic Health System - Morristown Medical Center

    Morristown, New Jersey, 07962

  • IHC Health Services Inc. DBA Intermountain Medical Center

    Murray, Utah, 84157-7000

  • Edgewater Medical Research

    New Smyrna Beach, Florida, 32169

  • Weill Cornell Medical Center

    New York, New York, 10065

  • Arizona Arrhythmia Research Center

    Phoenix, Arizona, 85016

  • Black Hills Cardiovascular Research

    Rapid City, South Dakota, 57701

  • Mayo Clinic

    Rochester, Minnesota, 55902

  • Baylor Scott and White Research Institute - Round Rock

    Round Rock, Texas, 78665

  • Heart House Research Foundation, LLC

    Springfield, Ohio, 45505

  • Iowa Heart Center

    West Des Moines, Iowa, 50266

Other trials in United States

Canada12 sites

  • Libin Cardiovascular Institute of Alberta - University of Calgary

    Calgary, Alberta, T2N 4Z6

  • Cambridge Cardiac Care Centre

    Cambridge, Ontario, N1R 6V6

  • Royal Alexandra Hospital

    Edmonton, Alberta, T5H 3V9

  • Dawson Road Medical Centre

    Guelph, Ontario, N1H 1B1

  • Hamilton Health Sciences

    Hamilton, Ontario, L8L 0A6

  • Montreal Heart Institute - Institut de Cardiologie de Montréal

    Montreal, Quebec, H1T 1C8

  • Partners in Advanced Cardiac Evaluation (PACE) Cardiology Clinic

    Newmarket, Ontario, M2R 3V6

  • CIUSSS de l'Estrie - CHUS ; Hôpital Fleurimont

    Sherbrooke, Quebec, J1H 5N4

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8

  • Vancouver General Hospital - Research Institute ; Gordon and Leslie Diamond Health Centre

    Vancouver, British Columbia, V5Z 1M9

  • Victoria Cardiac Arrhythmia Trials, Inc.

    Victoria, British Columbia, V8T 1Z4

  • University of Manitoba, St Boniface General Hospital

    Winnipeg, Manitoba, R2H 2A6

Other trials in Canada

About this study

Official title: Multi-Centre, Open-Label, Safety Study of Etripamil Nasal Spray in Spontaneous Episodes of Paroxysmal Supraventricular Tachycardia The NODE-302 Trial (Extension of NODE-301)

The primary objective of this study is to evaluate the safety of etripamil nasal spray (NS) 70 mg when self-administered by patients with an episode of Paroxysmal Supraventricular Tachycardia in an outpatient setting (i.e., without medical supervision).

Read the detailed description

The NODE-302 study is an extension of the NODE-301 efficacy study. It is a multi-centre, open label study designed to evaluate the safety of etripamil NS 70 mg when self-administered by patients for spontaneous episodes of PSVT in an outpatient setting. All patients randomized in the NODE-301 study and who meet the inclusion and exclusion criteria of the NODE-302 study are eligible for the NODE-302 study.

After each episode of PSVT, patients will have the option to continue in the NODE-302 study and manage subsequent episodes of PSVT with etripamil NS 70 mg if they do not meet any withdrawal criteria.

Each episode of PSVT will be documented by an ambulatory cardiac monitoring system (CMS) that will be placed on the chest by the patient or caregiver when symptoms begin, and will record at least 5 hours of continuous ECG.

The study will include a Qualification Visit, a Treatment Period(s) , a Follow-up Visit(s) ,a Final Study Visit and if necessary an Early Termination Visit if the patient withdraws from the study after taking etripamil NS 70 mg and had a Follow-up Visit, or the patient withdraws from the study and did not take etripamil NS 70 mg.

Being tested
Etripamil NS 70 mg, Aptar Pharma Nasal Spray Bidose System
Keywords
Paroxysmal supraventricular tachycardia, cardiac monitoring, atrioventricular nodal reentrant tachycardia, atrioventricular reciprocating tachycardia, calcium channel blocker, conversion rate
Medical subject headings
Tachycardia, Ventricular, Tachycardia, Atrioventricular Nodal Reentry

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Etripamil NS 70 mgDrug

    Also called MSP-2017

    All patients will receive a total of 200 micro-liters of etripamil NS 70 mg via the Aptar Pharma Nasal Spray Bidose System each time they self-administer study drug.

  • Aptar Pharma Nasal Spray Bidose SystemDevice

    Patients will self-administer the study drug using the Aptar Pharma Nasal Spray Bidose System. The devices will be prefilled and packaged into child-resistant boxes.Instructions for its use will be provided in the study drug box.

Study groups in NCT03635996
Study groupRoleWhat they receive
Etripamil NS 70 mgExperimentalThe dose of etripamil to be evaluated in NODE-302 is 70 mg.
Receives: Drug: Etripamil NS 70 mg; Device: Aptar Pharma Nasal Spray Bidose System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to Conversion of an Episode of PSVT to Sinus Rhythm (SR) After Study Drug Administration.

    The efficacy analyses were performed on the Efficacy Population. The primary efficacy variable was the time to conversion of an episode of PSVT to SR after study drug administration.

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2018
  2. Study start10 Dec 2018
  3. Primary completion13 Nov 2020
  4. Study completion13 Nov 2020

Why it stopped: Study was stopped by the Sponsor

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
169 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03635996
Sponsor's protocol ID
MSP-2017-1158
Status last verified
Mar 2021
First submitted
14 Aug 2018
Last updated
5 Nov 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Ip JE, Coutu B, Bennett MT, Pandey AS, Stambler BS, Sager P, Chen M, Shardonofsky S, Plat F, Camm AJ. Etripamil Nasal Spray for Conversion of Repeated Spontaneous Episodes of Paroxysmal Supraventricular Tachycardia During Long-Term Follow-Up: Results From the NODE-302 Study. J Am Heart Assoc. 2023 Oct 3;12(19):e028227. doi: 10.1161/JAHA.122.028227. Epub 2023 Sep 27.

    PubMed 37753718

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Etripamil NS 70 mg and Aptar Pharma Nasal Spray Bidose System in people with Paroxysmal Supraventricular Tachycardia, run by Milestone Pharmaceuticals Inc. at 34 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Conversion of an Episode of PSVT to Sinus Rhythm (SR) After Study Drug Administration. (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03635996, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2024.

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