Etripamil Nasal Spray for Supraventricular Tachycardia

Recruiting in Palo Alto (17 mi)

+26 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Milestone Pharmaceuticals Inc.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?This trial allows patients with PSVT to continue using a nasal spray called etripamil NS. The spray helps quickly stop fast heart rate episodes without needing a hospital visit. It offers an at-home treatment option and may reduce the need for ongoing medications or invasive procedures. Etripamil shows promise in offering out-of-hospital treatment for patients with PSVT.

Eligibility Criteria

This trial is for postmenopausal women or those who can't bear children, and men with a rapid heartbeat condition called PSVT. They must have been in a prior etripamil study without significant safety issues and agree to follow the study rules. Pregnant women, people with severe heart problems, low blood pressure after etripamil use, or certain drug therapies are excluded.

Inclusion Criteria

Women of childbearing potential who are sexually active with a male partner who is not surgically sterile 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

Willing and able to comply with Investigator instructions on etripamil NS use and study requirements

I am a woman not capable of becoming pregnant due to menopause or surgery.

+2 more

Exclusion Criteria

I have had a serious heart rhythm problem.

Is pregnant, breastfeeding, or is planning to become pregnant during the study

I do not have any health or mental conditions that would stop me from safely following the study.

+10 more

Participant Groups

The trial tests Etripamil Nasal Spray (70 mg) using Aptar Pharma's system on patients with Paroxysmal Supraventricular Tachycardia (PSVT). It's an open-label extension for those previously in Milestone Pharmaceuticals' trials to continue treatment.

1Treatment groups

Experimental Treatment

Group I: Etripamil NS 70 mgExperimental Treatment2 Interventions

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.

Etripamil NS is already approved in United States for the following indications:

🇺🇸 Approved in United States as CARDAMYST for: