Nasal spray could tame racing heart episodes at home

NCT ID NCT04952610

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a nasal spray called etripamil for people with a condition that causes sudden rapid heartbeats (PSVT). Participants, who had been in earlier studies, used the spray themselves at home to stop an episode. The main goal was to see if it was safe and easy to use outside the clinic.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

130 people

The number who actually took part.

Started

Dec 2021

Finished

Apr 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: A patient will be eligible for study participation if they meet all of the following criteria: 1. 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. 2. Has signed the MSP-2017-1278 written informed consent; 3. 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: 1. Documented hysterectomy; or 2. Documented bilateral salpingectomy; or 3. Documented bilateral oophorectomy; or All females who do not meet at least one of the above criteria are considered to be of childbearing potential 4. Willing and able to comply with Investigator instructions on etripamil NS use and study requirements. Exclusion Criteria: A patient will be excluded from the study if they meet any of the following criteria: 1. History of allergic reaction to verapamil, etripamil, or any of the investigational medical components; 2. 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; 3. History of ventricular pre-excitation, e.g., delta waves, Wolff-Parkinson-White syndrome; 4. History of a second- or third-degree atrioventricular block; 5. History of sick sinus syndrome and marked bradycardia (≤40 beats/minute); 6. History or evidence of severe ventricular arrhythmia (e.g. torsades de points, ventricular fibrillation, or sustained ventricular tachycardia) 7. Symptoms of congestive heart failure New York Heart Association Class II to IV; 8. 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; 9. Syncope due to an arrhythmic etiology or unexplained syncope during or after participation in an etripamil clinical research trial; 10. Is pregnant, breastfeeding, or is planning to become pregnant during the study; 11. History of acute coronary syndrome (without successful revascularization) or stroke within 6 months of enrollment; 12. Evidence of symptoms of hypotension within 24 hours following previous administration of etripamil, per Investigator's opinion. 13. 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Site # 0102

    Atlanta, Georgia, 30309, United States

  • Site # 0105

    Yardley, Pennsylvania, 19067, United States

  • Site # 0110

    Toledo, Ohio, 43606-, United States

  • Site # 0114

    New York, New York, 10065, United States

  • Site # 0122

    Rapid City, South Dakota, 57701, United States

  • Site # 0137

    Macon, Georgia, 31201, United States

  • Site # 0149

    Fort Wayne, Indiana, 46845, United States

  • Site # 0160

    Little Rock, Arkansas, 72205, United States

  • Site # 0166

    Lansing, Michigan, 48912, United States

  • Site # 0203

    Montreal, Quebec, H1T 1C8, Canada

  • Site # 0204

    Toronto, Ontario, M5B 1W8, Canada

  • Site # 0205

    Montreal, Quebec, H2X 0A9, Canada

  • Site # 0210

    Halifax, Nova Scotia, B3H 3A7, Canada

  • Site # 0213

    Victoria, British Columbia, V8T 1Z4, Canada

  • Site # 1007

    Salisbury, Maryland, 21801, United States

  • Site # 1023

    Vista, California, 92083, United States

  • Site # 1024

    Canton, Ohio, 44710, United States

  • Site # 1025

    West Des Moines, Iowa, 50266, United States

  • Site # 1047

    Austin, Texas, 78723, United States

  • Site # 1083

    West Hills, California, 91307, United States

  • Site # 1115

    Coeur d'Alene, Idaho, 83814, United States

  • Site # 1123

    Corvallis, Oregon, 97330, United States

  • Site # 2006

    Oshawa, Ontario, L1J 2K1, Canada

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