Etripamil Nasal Spray for Supraventricular Tachycardia

Recruiting at 26 trial locations

Overseen By Douglas Wight, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Milestone Pharmaceuticals Inc.

Must not be taking: Digoxin, Class I/III antiarrhythmics

Disqualifiers: Allergy to verapamil, Etripamil, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: Ongoing

130 Participants Needed

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.

Will I have to stop taking my current medications?

If you are currently taking digoxin or any Class I or III antiarrhythmic drugs, you will need to stop them at least five half-lives before joining the trial. If you are taking oral amiodarone, it must be stopped 30 days before enrollment.

What data supports the effectiveness of the drug Etripamil Nasal Spray for treating paroxysmal supraventricular tachycardia (PSVT)?

Research shows that Etripamil Nasal Spray can help stop episodes of PSVT quickly, with about 60% of episodes converting to a normal heart rhythm within 30 minutes. It is generally safe for self-use, with mild side effects like nasal congestion and discomfort. ^{1 2 3 4 5}

What makes the drug Etripamil Nasal Spray unique for treating supraventricular tachycardia?

Etripamil Nasal Spray is unique because it is administered through the nose, offering a non-invasive and rapid method to manage supraventricular tachycardia, unlike traditional treatments that may require intravenous administration or oral medications. ^{6 7 8 9 10}

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Self-administration of etripamil NS 70 mg for acute episodes of PSVT

Ongoing

Participants receive up to 4 pre-filled devices at a time

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension

Participants continue treatment with etripamil NS after previous trial participation

Long-term

Treatment Details

Interventions

• Etripamil NS

Trial Overview 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.

Participant Groups

Group I: Etripamil NS 70 mg Experimental Treatment 2 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:

• Paroxysmal supraventricular tachycardia (PSVT)

Who Is Running the Clinical Trial?

Milestone Pharmaceuticals Inc.

Lead Sponsor

Trials

11

Recruited

4,500+

Findings from Research

Tri-Nasal Nasal Spray, containing triamcinolone acetonide, was found to be significantly more effective than placebo in relieving nasal symptoms of allergic rhinitis, with results showing improvement as early as the second day of treatment in a study involving 377 adult patients over a 2-week period.

Both the 400 microgram dose of Tri-Nasal Nasal Spray and the active control, Nasacort, demonstrated comparable safety profiles and efficacy in treating nonocular symptoms of seasonal allergic rhinitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tri-Nasal triamcinolone acetonide nasal spray 200 and 400 micrograms qd versus placebo and Nasacort triamcinolone acetonide nasal aerosol 440 micrograms qd in patients suffering from seasonal allergic rhinitis during the grass season. Rosenthal, R., Berger, W., Bronsky, E., et al.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Update on Etripamil Nasal Spray for the At-home Treatment of Acute Paroxysmal Supraventricular Tachycardia. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Etripamil Nasal Spray for Conversion of Repeated Spontaneous Episodes of Paroxysmal Supraventricular Tachycardia During Long-Term Follow-Up: Results From the NODE-302 Study. [2023]

3. New Zealand pubmed.ncbi.nlm.nih.gov

The Efficacy and Safety of Etripamil Nasal Spray for Acute Paroxysmal Supraventricular Tachycardia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Etripamil nasal spray: an investigational agent for the rapid termination of paroxysmal supraventricular tachycardia (SVT). [2020]

5. United States pubmed.ncbi.nlm.nih.gov

First Randomized, Multicenter, Placebo-Controlled Study of Self-Administered Intranasal Etripamil for Acute Conversion of Spontaneous Paroxysmal Supraventricular Tachycardia (NODE-301). [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Tri-Nasal triamcinolone acetonide nasal spray 200 and 400 micrograms qd versus placebo and Nasacort triamcinolone acetonide nasal aerosol 440 micrograms qd in patients suffering from seasonal allergic rhinitis during the grass season. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Olopatadine-mometasone combination nasal spray: Evaluation of efficacy and safety in patients with seasonal allergic rhinitis. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Safety and efficacy of olopatadine hydrochloride nasal spray for the treatment of seasonal allergic rhinitis. [2015]

9. England pubmed.ncbi.nlm.nih.gov

Sumatriptan nasal spray in the acute treatment of migraine: a review of clinical studies. [2017]

10. Italy pubmed.ncbi.nlm.nih.gov

[Nedocromil sodium nasal spray in the treatment of seasonal allergic rhinitis]. [2013]