What side effects are associated with this type of intervention?

Common treatments for Supraventricular Tachycardia (SVT) include calcium channel blockers like verapamil and diltiazem, which can cause side effects such as dizziness, headache, flushing, and constipation. Beta-blockers, another common treatment, may lead to fatigue, cold extremities, and bradycardia. Antiarrhythmic drugs like adenosine can cause chest pain, shortness of breath, and a sense of impending doom, while amiodarone is associated with more severe side effects including thyroid dysfunction, pulmonary toxicity, and liver damage.

What prior FDA approvals exist?

The FDA has approved several treatments for Supraventricular Tachycardia (SVT), including calcium channel blockers such as verapamil and diltiazem. These medications work by slowing down the conduction of electrical impulses through the heart, thereby controlling the heart rate. Other approved treatments include beta-blockers like metoprolol and antiarrhythmic drugs such as adenosine. Etripamil NS, currently under study, is a nasal spray formulation of a calcium channel blocker, offering a novel route of administration for rapid termination of SVT episodes.

What other types of research exist?

Promising novel alternatives to Etripamil NS for SVT patients include: 1) Vernakalant, which has shown efficacy in cardioversion of recent-onset atrial fibrillation and may be applicable to SVT. 2) Dronedarone, which has been compared favorably to amiodarone for maintaining sinus rhythm. 3) Ibutilide, which has demonstrated rapid conversion of atrial arrhythmias and may be effective for SVT. These alternatives have shown potential in clinical studies and could be considered for treatment in 2024.

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Calcium Channel Blocker

Etripamil Nasal Spray 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

Postmenopausal females, defined as having amenorrhea for at least 12 months without an alternative medical cause; or premenopausal females with documented hysterectomy, bilateral salpingectomy, or bilateral oophorectomy are not considered to be of childbearing potential

Be older than 18 years old

Must not have

History of a second- or third-degree atrioventricular block

History of allergic reaction to verapamil, etripamil, or any of the investigational medical components

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects of Etripamil may include symptoms like low blood pressure, which could lead to dizziness or fainting. Since it affects heart rhythm, there might be risks of other heart-related side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a serious heart rhythm problem.

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I am allergic to verapamil, etripamil, or similar medications.

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I am not currently on digoxin or specific heart rhythm medications, or I can stop them before joining the study.

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I experience symptoms of heart failure that affect my daily activities.

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I have had fainting spells due to heart rhythm problems or unexplained reasons during a previous etripamil study.

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I have a history of severe irregular heartbeats.

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I have a history of sick sinus syndrome and my heart rate is very slow.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Calcium channel blockers, such as verapamil and diltiazem, treat Supraventricular Tachycardia (SVT) by inhibiting calcium ion influx through L-type calcium channels in the heart. This action slows conduction through the atrioventricular (AV) node, prolongs the refractory period, and reduces the strength of heart muscle contractions, thereby helping to control and prevent rapid heart rates. This is crucial for SVT patients as it helps to alleviate symptoms and improve their quality of life.