Paroxysmal Supraventricular TachycardiaPhase 3NCT04952610
Etripamil Nasal Spray in Patients With Paroxysmal Supraventricular Tachycardia
A Phase 3 study testing Etripamil NS 70 mg and Aptar Pharma Nasal Spray Bidose System in people with Paroxysmal Supraventricular Tachycardia, run by Milestone Pharmaceuticals Inc. at 23 sites in 2 countries.
Trial summary
This Open Label Extension study will enable eligible patients with Paroxysmal Supraventricular Tachycardia (PSVT) who have previously participated in a Milestone Pharmaceuticals clinical trial of etripamil NS for PSVT, to access continued treatment with etripamil NS, Patients who experienced any significant safety… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paroxysmal Supraventricular Tachycardia
- What is being tested?
- Etripamil NS 70 mg and Aptar Pharma Nasal Spray Bidose System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 23 sitesin 2 countries
- Study dates
- 13 Dec 2021to 10 Apr 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A patient will be eligible for study participation if they meet all of the following criteria:
- 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.
- Has signed the MSP-2017-1278 written informed consent;
- 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
Show all 12Show fewer
- Premenopausal females with 1 of the following:
- Documented hysterectomy; or
- Documented bilateral salpingectomy; or
- Documented bilateral oophorectomy; or
- All females who do not meet at least one of the above criteria are considered to be of childbearing potential
- Willing and able to comply with Investigator instructions on etripamil NS use and study requirements.
Who cannot join
- A patient will be excluded from the study if they meet any of the following criteria:
- History of allergic reaction to verapamil, etripamil, or any of the investigational medical components;
- 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;
- History of ventricular pre-excitation, e.g., delta waves, Wolff-Parkinson-White syndrome;
- History of a second- or third-degree atrioventricular block;
- History of sick sinus syndrome and marked bradycardia (≤40 beats/minute);
Show all 14Show fewer
- History or evidence of severe ventricular arrhythmia (e.g. torsades de points, ventricular fibrillation, or sustained ventricular tachycardia)
- Symptoms of congestive heart failure New York Heart Association Class II to IV;
- 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;
- Syncope due to an arrhythmic etiology or unexplained syncope during or after participation in an etripamil clinical research trial;
- Is pregnant, breastfeeding, or is planning to become pregnant during the study;
- History of acute coronary syndrome (without successful revascularization) or stroke within 6 months of enrollment;
- Evidence of symptoms of hypotension within 24 hours following previous administration of etripamil, per Investigator's opinion.
- 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.
Trial locations and contacts
23 sites in 2 countries.
23 sites in 2 countries
United States17 sites
Site # 0102
Atlanta, Georgia, 30309
Site # 1047
Austin, Texas, 78723
Site # 1024
Canton, Ohio, 44710
Site # 1115
Coeur d'Alene, Idaho, 83814
Site # 1123
Corvallis, Oregon, 97330
Site # 0149
Fort Wayne, Indiana, 46845
Site # 0166
Lansing, Michigan, 48912
Site # 0160
Little Rock, Arkansas, 72205
Site # 0137
Macon, Georgia, 31201
Site # 0114
New York, New York, 10065
Site # 0122
Rapid City, South Dakota, 57701
Site # 1007
Salisbury, Maryland, 21801
Site # 0110
Toledo, Ohio, 43606-
Site # 1023
Vista, California, 92083
Site # 1025
West Des Moines, Iowa, 50266
Site # 1083
West Hills, California, 91307
Site # 0105
Yardley, Pennsylvania, 19067
Canada6 sites
Site # 0210
Halifax, Nova Scotia, B3H 3A7
Site # 0203
Montreal, Quebec, H1T 1C8
Site # 0205
Montreal, Quebec, H2X 0A9
Site # 2006
Oshawa, Ontario, L1J 2K1
Site # 0204
Toronto, Ontario, M5B 1W8
Site # 0213
Victoria, British Columbia, V8T 1Z4
About this study
Official title: An Open Label Extension Study of Etripamil Nasal Spray in Patients With Paroxysmal Supraventricular Tachycardia
This Open Label Extension study will enable eligible patients with Paroxysmal Supraventricular Tachycardia (PSVT) who have previously participated in a Milestone Pharmaceuticals clinical trial of etripamil NS for PSVT, to access continued treatment with etripamil NS, Patients who experienced any significant safety issues during participation period in a previous clinical trial of etripamil NS, as per Investigator's assessment , are excluded. This study will be conducted by Investigators who previously participated in a Milestone Pharmaceuticals clinical trial and are trained on the use of etripamil NS.
Read the detailed description
Etripamil NS addresses an unmet medical need since there are currently no fast-acting products available for patient self-administered treatment of episodes of PSVT. The only currently available acute pharmacological therapy is IV treatment with adenosine or calcium channel blockers administered in a hospital or medically supervised environment. A self-administered product for PSVT would give patients the option to safely terminate acute episodes of PSVT without the need for a hospital visit and potential admission. An episodic treatment option may also allow selected patients to discontinue chronic prophylactic therapy with Class I, II (e.g., beta-blockers), III, and/or IV (e.g., calcium channel blockers) antiarrhythmic agents, thus avoiding the side effects and quality of life implications associated with these medications. Furthermore, patients weighing the risks of bridging therapy and an invasive catheter ablation procedure to address their PSVT would have the opportunity to consider episodic management with etripamil NS as a viable alternative treatment option.
The potential risks of study participation include those associated with exposure to etripamil NS. The side effect profile appears to be consistent with its expected pharmacology as a short-acting structural analog of verapamil, as well as with its delivery as moderately low pH nasal spray formulation. The most frequently reported (≥5% of subjects across all studies) AEs determined by the investigator to be possibly, probably, or definitely related to etripamil NS include headache, increased lacrimation, epistaxis, nasal congestion, nasal discomfort, rhinorrhea, sneezing and throat irritation.
Potential AEs, which have been rare or not observed in studies to date, include other cardiac arrhythmias, or AEs associated with drops in blood pressure (syncope, symptomatic hypotension).
The primary benefit of this study is that patients may be able to safely and rapidly terminate acute episodes of PSVT without the need for a hospital visit to receive IV medication. Patients may also be able to discontinue chronic prophylactic therapies they are taking for PSVT. Patients who are waiting for, ineligible, or unwilling to undergo ablation procedures may have an option for at-home treatment of their PSVT episodes.
- Conditions
- Paroxysmal Supraventricular Tachycardia
- Being tested
- Etripamil NS 70 mg, Aptar Pharma Nasal Spray Bidose System
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Etripamil NS 70 mgDrug
Etripamil will be administered via the Aptar Pharma Nasal Spray Bidose System.
Aptar Pharma Nasal Spray Bidose SystemDevice
Aptar Pharma Nasal Spray Bidose System will be supplied as prefilled devices packaged into child-resistant boxes with instructions for use provided in the study drug box.
| Study group | Role | What they receive |
|---|---|---|
| Etripamil NS 70 mg | Experimental | 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. Receives: Drug: Etripamil NS 70 mg; Device: Aptar Pharma Nasal Spray Bidose System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start13 Dec 2021
- Primary completion10 Apr 2026
- Study completion10 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paroxysmal Supraventricular TachycardiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a multicenter study to enable patients with PVST to have continued access of etripamil NS. The study will only include patients who have participated in a Milestone Pharmaceuticals Inc. approved clinical research trial (NODE-301 Part 1, RAPID Study (NODE-301 Part 2), NODE-302, or NODE-303) of etripamil NS for PSVT. Patients who experienced any significant safety issues during participation in a previous study, as per Investigator's assessment, are excluded. This study is planned to continue until etripamil NS is commercially available for patients with PSVT or the study is terminated by the Sponsor for any reason.
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milestone Pharmaceuticals Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04952610
- Sponsor's protocol ID
- MSP-2017-1278
- Status last verified
- May 2026
- First submitted
- 23 Apr 2021
- Last updated
- 15 May 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Extension Study of Etripamil Nasal Spray in Patients With Paroxysmal Supraventricular Tachycardia
- ClinicalTrials.gov ID
- NCT04952610
- Acronym / sponsor ID
- MSP-2017-1278
- Conditions
- Paroxysmal Supraventricular Tachycardia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Milestone Pharmaceuticals Inc.University, hospital or other
- Study start
- 13 Dec 2021 (actual)
- Primary completion
- 10 Apr 2026 (actual)
- Study completion
- 10 Apr 2026 (actual)
- First posted
- 7 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Open Label Extension study will enable eligible patients with Paroxysmal Supraventricular Tachycardia (PSVT) who have previously participated in a Milestone Pharmaceuticals clinical trial of etripamil NS for PSVT, to access continued treatment with etripamil NS, Patients who experienced any significant safety issues during participation period in a previous clinical trial of etripamil NS, as per Investigator's assessment , are excluded. This study will be conducted by Investigators who previously participated in a Milestone Pharmaceuticals clinical trial and are trained on the use of etripamil NS.
Detailed description
Etripamil NS addresses an unmet medical need since there are currently no fast-acting products available for patient self-administered treatment of episodes of PSVT. The only currently available acute pharmacological therapy is IV treatment with adenosine or calcium channel blockers administered in a hospital or medically supervised environment. A self-administered product for PSVT would give patients the option to safely terminate acute episodes of PSVT without the need for a hospital visit and potential admission. An episodic treatment option may also allow selected patients to discontinue chronic prophylactic therapy with Class I, II (e.g., beta-blockers), III, and/or IV (e.g., calcium channel blockers) antiarrhythmic agents, thus avoiding the side effects and quality of life implications associated with these medications. Furthermore, patients weighing the risks of bridging therapy and an invasive catheter ablation procedure to address their PSVT would have the opportunity to consider episodic management with etripamil NS as a viable alternative treatment option.
The potential risks of study participation include those associated with exposure to etripamil NS. The side effect profile appears to be consistent with its expected pharmacology as a short-acting structural analog of verapamil, as well as with its delivery as moderately low pH nasal spray formulation. The most frequently reported (≥5% of subjects across all studies) AEs determined by the investigator to be possibly, probably, or definitely related to etripamil NS include headache, increased lacrimation, epistaxis, nasal congestion, nasal discomfort, rhinorrhea, sneezing and throat irritation.
Potential AEs, which have been rare or not observed in studies to date, include other cardiac arrhythmias, or AEs associated with drops in blood pressure (syncope, symptomatic hypotension).
The primary benefit of this study is that patients may be able to safely and rapidly terminate acute episodes of PSVT without the need for a hospital visit to receive IV medication. Patients may also be able to discontinue chronic prophylactic therapies they are taking for PSVT. Patients who are waiting for, ineligible, or unwilling to undergo ablation procedures may have an option for at-home treatment of their PSVT episodes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a multicenter study to enable patients with PVST to have continued access of etripamil NS. The study will only include patients who have participated in a Milestone Pharmaceuticals Inc. approved clinical research trial (NODE-301 Part 1, RAPID Study (NODE-301 Part 2), NODE-302, or NODE-303) of etripamil NS for PSVT. Patients who experienced any significant safety issues during participation in a previous study, as per Investigator's assessment, are excluded. This study is planned to continue until etripamil NS is commercially available for patients with PSVT or the study is terminated by the Sponsor for any reason.
| Arm | Type | Receives |
|---|---|---|
| Etripamil NS 70 mg | Experimental | Drug: Etripamil NS 70 mg, Device: Aptar Pharma Nasal Spray Bidose SystemSelf- 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- A patient will be eligible for study participation if they meet all of the following criteria:
- 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.
- Has signed the MSP-2017-1278 written informed consent;
- 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:
Key exclusion criteria (14 listed)
- History of allergic reaction to verapamil, etripamil, or any of the investigational medical components;
- 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;
- History of ventricular pre-excitation, e.g., delta waves, Wolff-Parkinson-White syndrome;
- History of a second- or third-degree atrioventricular block;
- History of sick sinus syndrome and marked bradycardia (≤40 beats/minute);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Etripamil NS 70 mgEtripamil will be administered via the Aptar Pharma Nasal Spray Bidose System. | Drug | Etripamil NS 70 mg |
| Aptar Pharma Nasal Spray Bidose SystemAptar Pharma Nasal Spray Bidose System will be supplied as prefilled devices packaged into child-resistant boxes with instructions for use provided in the study drug box. | Device | Etripamil NS 70 mg |
Primary outcome
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.
Time frame: Up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
23 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Etripamil NS 70 mg and Aptar Pharma Nasal Spray Bidose System in people with Paroxysmal Supraventricular Tachycardia, run by Milestone Pharmaceuticals Inc. at 23 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.