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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trial will allow patients who have safely used etripamil in the past to continue using it during the completion of the Phase 3 PSVT program.

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.Check my eligibility
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.See study design
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
Select...
I am a woman not capable of becoming pregnant due to menopause or surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The safety of self-administered etripamil Nasal Spray (NS) for treatment of episodes of PSVT outside of the clinical setting as assessed by patient-reported adverse events.

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.

Find a Location

Who is running the clinical trial?

Milestone Pharmaceuticals Inc.Lead Sponsor
9 Previous Clinical Trials
3,229 Total Patients Enrolled

Media Library

Etripamil NS (Calcium Channel Blocker) Clinical Trial Eligibility Overview. Trial Name: NCT04952610 — Phase 3
Supraventricular Tachycardia Research Study Groups: Etripamil NS 70 mg
Supraventricular Tachycardia Clinical Trial 2023: Etripamil NS Highlights & Side Effects. Trial Name: NCT04952610 — Phase 3
Etripamil NS (Calcium Channel Blocker) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04952610 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there other scientific research projects that have focused on Etripamil NS 70 mg?

"Etripamil NS 70 mg is currently being trialled in 4 different studies, 3 of which are in Phase 3. Out of the 392 total locations where these clinical trials are taking place, the majority of them are based in Hershey, Pennsylvania."

Answered by AI

Are there many sites running this clinical trial in the city?

"This study has a presence in Site # 0133 in Salt Lake City, Utah, Site # 2006 in Oshawa, Ontario, Site # 0102 in Atlanta, Georgia as well as other 14 sites."

Answered by AI

Has the FDA granted its official blessing to Etripamil NS 70 mg?

"There is a solid amount of data from Phase 3 trials indicating both the efficacy and safety of Etripamil NS 70 mg, so it received a score of 3."

Answered by AI

Has this research been published before?

"Since 2018, Etripamil NS 70 mg has been the focus of 4 active studies in 21 countries and 180 cities. The first trial was sponsored by Medpace, Inc. and took place in 2018 with 701 participants. After the first study, Phase 3 drug approval was received."

Answered by AI

Who else is applying?

What site did they apply to?
Site # 0133
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Etripamil Nasal Spray in Patients With Paroxysmal Supraventricular Tachycardia
2021. "Etripamil Nasal Spray in Patients With Paroxysmal Supraventricular Tachycardia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04952610.
All > Paroxysmal Supraventricular Tachycardia
~37 spots leftby Apr 2025
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