Paroxysmal Supraventricular TachycardiaPhase 2NCT05763953
The NODE-202 Study (Study of Etripamil Nasal Spray in Pediatric Patients)
A Phase 2 study testing Etripamil NS in people with Paroxysmal Supraventricular Tachycardia, run by Milestone Pharmaceuticals Inc. at 10 sites in 4 countries.
Trial summary
NODE-202 is a Phase 2, multicenter, multinational, single dose, open-label, 2-part, sequential design study in pediatric patients with an established diagnosis of paroxysmal supraventricular tachycardia (PSVT) presenting with a symptomatic episode of PSVT. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Paroxysmal Supraventricular Tachycardia
- What is being tested?
- Etripamil NS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 10 sitesin 4 countries
- Study dates
- 11 Dec 2023to 30 Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients will be eligible for study participation if they meet all of the following criteria at screening:
- Male or female patients
- Part 1: patients 12 to <18 years of age
- Part 2: patients 6 to <12 years of age
- Body mass index (BMI) between the 5th and the 85th percentiles interpreted relative sex and age
- History of PSVT documented by ECG or other monitoring modality (e.g., Holter monitor, event recorder) showing SVT involving the Atrioventricular (AV) node (i.e., Atrioventricular nodal reentry tachycardia (AVNRT) or Atrioventricular reentrant tachycardia (AVRT)). If patient had a prior ablation for PSVT, patient must have documented evidence of PSVT post-ablation
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- Signed written informed consent/assent obtained
- Per Investigator's decision, females of childbearing potential (defined as any woman or adolescent who has begun menstruation) must additionally satisfy the following criteria:
- Negative pregnancy test at screening
- Adequate contraception, unless total abstinence is used
- Willing and able to comply with study procedures.
Who cannot join
- Patients will be excluded from the study if they meet any of the following criteria:
- History or presence of any of the following at the screening visit:
- Patients with a history of atrial arrhythmia that does not involve the AV node as part of the tachycardia circuit (e.g., atrial fibrillation, atrial flutter, atrial tachycardia) are not eligible
- Permanent junctional reciprocating tachycardia
- Ventricular pre-excitation (e.g., delta wave on ECG, Wolff Parkinson White syndrome)
- Second- or third-degree AV block
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- Sick sinus syndrome or clinically significant bradycardia (<50 bpm or equivalent in this patient population) on the resting ECG
- Ventricular tachycardia
- Long QT syndrome
- Major structural heart disease (e.g., Ebstein's anomaly, corrected congenital heart disease) or symptoms of congestive heart failure (New York Heart Association class II to IV).
- Evidence of impaired liver function (alanine aminotransferase [ALT] and/or aspartate aminotransferase [AST] >3 x upper limit of normal for age and gender) at the Screening Visit
- Evidence of End-Stage Renal Disease as determined by an estimated glomerular filtration rate assessed at the Screening Visit of <15 mL/min/1.73m2, or requiring hemodialysis;
- Treatment with any of the following that cannot or will not be discontinued during study participation:
- Any investigational drug within 60 days prior to study drug administration
- IV beta-adrenergic blocking drugs (e.g., propranolol, esmolol), calcium channel blocking drugs (e.g., verapamil, diltiazem) or amiodarone within 24 hours prior to study drug administration
- Oral amiodarone within 30 days prior to study drug administration
- Class I or III antiarrhythmic agents (e.g., flecainide, propafenone, sotalol) within five half-lives prior to study drug administration
- Any other drug that has a contraindication with verapamil
- Known hypersensitivity to verapamil or to any of the excipients of the study drug
- Any other significant co-morbid condition that may have a negative impact on the patient's participation in the study or likely to result in non-compliance
- History of hyperthyroidism
- Current pregnancy or breastfeeding
Trial locations and contacts
10 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
10 sites in 4 countries
United States6 sites, 6 recruiting
- Not yet recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Shankar Baskar, shankar.baskar@cchmc.org
Shankar Baskar
- Not yet recruiting
Baylor College of Medicine
Houston, Texas, 77030
Santiago Valdes, sovaldes@texaschildrens.org
Santiago Valdes
- Not yet recruiting
Le Bonheur Children's Hospital
Memphis, Tennessee, 38103
Karine Guerrier, kguerrie@uthsc.edu
Karine Guerrier
- Not yet recruiting
Advocate Children's Hospital
Oak Lawn, Illinois, 60453
Frank Zimmerman, Frank.Zimmerman@aah.org
Frank Zimmerman
- Recruiting
Phoenix Children's Hospital
Phoenix, Arizona, 85016
Andrew Papez, apapez@phoenixchildrens.com
Andrew Papez
- Recruiting
Oregon Health and Science University
Portland, Oregon, 97239
Seshadri Balaji, balajis@ohsu.edu
Seshadri Balaji
Spain2 sites, 2 recruiting
- Not yet recruiting
Hospital Sant Joan de Déu
Barcelona, 08950
Georgia Brugada
Georgia Brugada
- Recruiting
Hospital Infantil Universitario La Paz
Madrid, 28046
Jose Merino
Jose Merino
Canada1 site, 1 recruiting
- Not yet recruiting
The University of British Columbia
Vancouver, V6H3V4
Shubhayan Sanatani
Shubhayan Sanatani
Germany1 site, 1 recruiting
- Not yet recruiting
Universitätsmedizin Göttingen, Klinik für Pädiatrische Kardiologie, Intensivmedizin und Neonatologie
Göttingen, 37075
Thomas Paul
Thomas Paul
About this study
Official title: The NODE-202 Study Multi-Center, Multi-National, Open-Label, Efficacy and Safety Study of Etripamil Nasal Spray in Pediatric Patients With Paroxysmal Supraventricular Tachycardia
NODE-202 is a Phase 2, multicenter, multinational, single dose, open-label, 2-part, sequential design study in pediatric patients with an established diagnosis of paroxysmal supraventricular tachycardia (PSVT) presenting with a symptomatic episode of PSVT.
In Part 1, at least 30 patients aged 12 to <18 years will be enrolled and treated with etripamil nasal spray (NS). Efficacy, safety, tolerability and PK (for at least 12 patients) will be assessed after administration of 70 mg etripamil NS (Part 1A). At least 18 subsequent patients will be enrolled and treated with the etripamil NS with the dose determined by the Pharmacokinetic (PK) analysis and will undergo efficacy and safety/tolerability assessments (Part 1B).
Read more
In Part 2, at least 30 patients aged 6 to <12 years will be enrolled and treated with etripamil NS at a dose selected based on appropriate body size-based modeling, as well as efficacy, safety/tolerability, and PK data collected in Part 1. Efficacy, safety, tolerability and PK (for at least 12 patients) will be assessed after administration of etripamil NS (Part 2A). At least 18 subsequent patients will be enrolled and treated with the etripamil NS with the dose determined by the PK analysis and will undergo efficacy and safety/tolerability assessments (Part 2B).
The study will include the following visits: A Screening Visit, A Treatment Visit, , and A Follow-Up/End of Study Visit.
Read the detailed description
NODE-202 is a Phase 2, multicenter, multinational, single-dose, open-label, 2-part, sequential design study of pediatric patients with an established diagnosis of PSVT presenting with a sustained, symptomatic episode of PSVT.
At least 60 evaluable patients administered etripamil NS are estimated as an adequate population to inform on the efficacy and safety of etripamil NS in pediatric patients (aged 6 to <18 years) with PSVT. Patients will be enrolled according to the following sequential design:
Part 1: At least 30 patients aged 12 to <18 years will be treated with 70 mg etripamil NS for a PSVT episode. Efficacy, safety, tolerability and PK (at least for 12 patients) will be assessed after administration of etripamil.
Part 1A: at least 12 patients will undergo efficacy, safety/tolerability, and PK assessments. The data safety monitoring committee (DSMC) will complete an interim assessment of safety, tolerability; if the Sponsor decides to increase the dose above 70 mg for the remaining 18 patients, the Pediatric Committee (PDCO) and the Food and Drug Administration (FDA) will complete an interim assessment of efficacy, safety, tolerability, and PK data before additional patients in this age group can be treated with etripamil at the same or a modified dose level.
Part 1B: at least 18 subsequent patients will be treated with etripamil NS with the dose determined based on Part 1A data analysis and will undergo efficacy and safety/tolerability assessments.
Part 2: Clinical assessments in at least 30 patients aged 6 to <12 years will only be undertaken if, after a comprehensive review of safety, tolerability, efficacy, and PK data collected in patients aged 12 to <18 years, confirms a positive benefit-risk ratio in that age group, sufficient to permit administration of etripamil NS in the younger age group. The initial dose for Part 2 will be selected based on appropriate body size-based modelling, as well as safety/tolerability, and efficacy data collected in Part 1.
Part 2A: at least 12 patients will undergo efficacy, safety/tolerability, and PK assessments. The DSMC will complete an interim assessment of safety, tolerability; the PDCO and FDA will complete an interim assessment of safety, tolerability, and PK data before additional patients in this age group can be treated with etripamil at the same or a modified dose level.
Part 2B: at least 18 subsequent patients will be enrolled and treated with etripamil NS with the dose determined based on Part 2A data analysis and will undergo efficacy and safety/tolerability assessments.
The study will include:
A Screening Visit during which the Investigator will verify that the patient currently meets the eligibility criteria of the NODE-202 study, will obtain the Informed Consent/Assent, will evaluate the patient's medical status and concomitant medications, will perform a 12-Lead ECG using provided study-specific equipment, will take blood and urine for clinical laboratory evaluations (local laboratory) and will assess the patient's eligibility according to the inclusion/exclusion criteria. Also, qualified patients will be instructed that as soon as they have identified symptoms they consider being consistent with PSVT, they must attend the Study Medical Facility assigned by their Investigator for a treatment visit.
A Treatment Visit during which patients will arrive at the Study Medical Facility with symptoms consistent with PSVT, and the following actions will be performed: confirmation of eligibility, evaluation of vital signs and initiation of a 12-lead Electrocardiogram (ECG) using the provided ECG equipment. If after ECG assessment diagnosis of PSVT is not confirmed, the patient must not be administered etripamil NS and will receive standard of care treatment based on the diagnosis. If ECG assessment confirms the presence of PSVT, a vagal maneuver (VM) will be performed by the patient or physician, based on the Investigator's judgement. If the VM is not successful in terminating the confirmed PSVT episode, etripamil NS will then be administered intranasally by study site personnel, under medical supervision and ECG monitoring for 1 hour.
A Follow-Up/End of Study Visit (1 to 5 days after an episode) during which any Adverse Events (AEs) and ECG will be recorded, and vital signs will be measured.
- Conditions
- Paroxysmal Supraventricular Tachycardia
- Being tested
- Etripamil NS
- Keywords
- PSVT
- 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 NSDrug
Part 1A: At least 12 patients will be administered with Etripamil NS (35 mg/100 μL per nostril) at a dose of 70 mg.
Part 1B: At least 18 following patients will be administered with Etripamil NS at a dose determined by analysis of data generated from Part 1A.
Part 2A: At least 12 patients will be administered with Etripamil NS at a dose selected based on appropriate body size-based modeling using PK assessments, as well as safety/tolerability, and efficacy data collected in Part 1.
Part 2B: At least 18 following patients will be administered with Etripamil NS at a dose determined by analysis of data generated from Part 2A.
| Study group | Role | What they receive |
|---|---|---|
| Etripamil NS 70mg | Experimental | Patients will be administered by study site personnel Receives: Drug: Etripamil NS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: The percentage of patients converting to sinus rhythm (SR) in the first 15 minutes after administration of etripamil NS.
A successful conversion is defined as conversion of PSVT to SR that is maintained for at least 30 seconds
Measured: 15 minutes after administration of etripamil NS
Secondary outcomes (6)
Efficacy: Time to termination of the PSVT episode and conversion to SR
Time measured from time of dosing to time of conversion of PSVT to SR that is maintained for at least 30 seconds
Measured: 60 minutes after administration of etripamil NS
Efficacy: Percentage of patients requiring additional medical intervention treatment for the PSVT episode in the first 15 minutes after study drug administration.
Medical intervention is defined as an administered drug or procedure to treat PSVT
Measured: 15 minutes after administration of etripamil NS
Safety: Frequency of AEs
Adverse Events (AEs) defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related
Measured: Until 5 days after administration of etripamil NS
Safety: Local (administration site) tolerability
Local tolerability defined as frequency of adverse events related to nasal spray site administration
Measured: Until 5 days after administration of etripamil NS
Safety: Post-dose changes in vital signs (Hearth rate (HR))
HR changes as measured by increase/decrease in beats per minute
Measured: Until 5 days after administration of etripamil NS
Safety: Post dose changes in vital sign (Blood Pressure (BP))
BP changes (systolic blood pressure (SBP) and diastolic blood pressure (DBP)) as measured in increase/decrease in mmHg
Measured: Until 5 days after administration of etripamil NS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start11 Dec 2023
- Primary completion1 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Milestone Pharmaceuticals Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Bharucha, MD, Study director, Milestone Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05763953
- Sponsor's protocol ID
- MSP-2017-1265
- Status last verified
- Jul 2026
- First submitted
- 3 Feb 2023
- Last updated
- 21 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The NODE-202 Study Multi-Center, Multi-National, Open-Label, Efficacy and Safety Study of Etripamil Nasal Spray in Pediatric Patients With Paroxysmal Supraventricular Tachycardia
- ClinicalTrials.gov ID
- NCT05763953
- Acronym / sponsor ID
- MSP-2017-1265
- Conditions
- Paroxysmal Supraventricular Tachycardia
- Keywords
- PSVT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Milestone Pharmaceuticals Inc.University, hospital or other
- Study start
- 11 Dec 2023 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 10 Mar 2023 (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.
NODE-202 is a Phase 2, multicenter, multinational, single dose, open-label, 2-part, sequential design study in pediatric patients with an established diagnosis of paroxysmal supraventricular tachycardia (PSVT) presenting with a symptomatic episode of PSVT.
In Part 1, at least 30 patients aged 12 to <18 years will be enrolled and treated with etripamil nasal spray (NS). Efficacy, safety, tolerability and PK (for at least 12 patients) will be assessed after administration of 70 mg etripamil NS (Part 1A). At least 18 subsequent patients will be enrolled and treated with the etripamil NS with the dose determined by the Pharmacokinetic (PK) analysis and will undergo efficacy and safety/tolerability assessments (Part 1B).
In Part 2, at least 30 patients aged 6 to <12 years will be enrolled and treated with etripamil NS at a dose selected based on appropriate body size-based modeling, as well as efficacy, safety/tolerability, and PK data collected in Part 1. Efficacy, safety, tolerability and PK (for at least 12 patients) will be assessed after administration of etripamil NS (Part 2A). At least 18 subsequent patients will be enrolled and treated with the etripamil NS with the dose determined by the PK analysis and will undergo efficacy and safety/tolerability assessments (Part 2B).
The study will include the following visits: A Screening Visit, A Treatment Visit, , and A Follow-Up/End of Study Visit.
Detailed description
NODE-202 is a Phase 2, multicenter, multinational, single-dose, open-label, 2-part, sequential design study of pediatric patients with an established diagnosis of PSVT presenting with a sustained, symptomatic episode of PSVT.
At least 60 evaluable patients administered etripamil NS are estimated as an adequate population to inform on the efficacy and safety of etripamil NS in pediatric patients (aged 6 to <18 years) with PSVT. Patients will be enrolled according to the following sequential design:
Part 1: At least 30 patients aged 12 to <18 years will be treated with 70 mg etripamil NS for a PSVT episode. Efficacy, safety, tolerability and PK (at least for 12 patients) will be assessed after administration of etripamil.
Part 1A: at least 12 patients will undergo efficacy, safety/tolerability, and PK assessments. The data safety monitoring committee (DSMC) will complete an interim assessment of safety, tolerability; if the Sponsor decides to increase the dose above 70 mg for the remaining 18 patients, the Pediatric Committee (PDCO) and the Food and Drug Administration (FDA) will complete an interim assessment of efficacy, safety, tolerability, and PK data before additional patients in this age group can be treated with etripamil at the same or a modified dose level.
Part 1B: at least 18 subsequent patients will be treated with etripamil NS with the dose determined based on Part 1A data analysis and will undergo efficacy and safety/tolerability assessments.
Part 2: Clinical assessments in at least 30 patients aged 6 to <12 years will only be undertaken if, after a comprehensive review of safety, tolerability, efficacy, and PK data collected in patients aged 12 to <18 years, confirms a positive benefit-risk ratio in that age group, sufficient to permit administration of etripamil NS in the younger age group. The initial dose for Part 2 will be selected based on appropriate body size-based modelling, as well as safety/tolerability, and efficacy data collected in Part 1.
Part 2A: at least 12 patients will undergo efficacy, safety/tolerability, and PK assessments. The DSMC will complete an interim assessment of safety, tolerability; the PDCO and FDA will complete an interim assessment of safety, tolerability, and PK data before additional patients in this age group can be treated with etripamil at the same or a modified dose level.
Part 2B: at least 18 subsequent patients will be enrolled and treated with etripamil NS with the dose determined based on Part 2A data analysis and will undergo efficacy and safety/tolerability assessments.
The study will include:
A Screening Visit during which the Investigator will verify that the patient currently meets the eligibility criteria of the NODE-202 study, will obtain the Informed Consent/Assent, will evaluate the patient's medical status and concomitant medications, will perform a 12-Lead ECG using provided study-specific equipment, will take blood and urine for clinical laboratory evaluations (local laboratory) and will assess the patient's eligibility according to the inclusion/exclusion criteria. Also, qualified patients will be instructed that as soon as they have identified symptoms they consider being consistent with PSVT, they must attend the Study Medical Facility assigned by their Investigator for a treatment visit.
A Treatment Visit during which patients will arrive at the Study Medical Facility with symptoms consistent with PSVT, and the following actions will be performed: confirmation of eligibility, evaluation of vital signs and initiation of a 12-lead Electrocardiogram (ECG) using the provided ECG equipment. If after ECG assessment diagnosis of PSVT is not confirmed, the patient must not be administered etripamil NS and will receive standard of care treatment based on the diagnosis. If ECG assessment confirms the presence of PSVT, a vagal maneuver (VM) will be performed by the patient or physician, based on the Investigator's judgement. If the VM is not successful in terminating the confirmed PSVT episode, etripamil NS will then be administered intranasally by study site personnel, under medical supervision and ECG monitoring for 1 hour.
A Follow-Up/End of Study Visit (1 to 5 days after an episode) during which any Adverse Events (AEs) and ECG will be recorded, and vital signs will be measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Etripamil NS 70mg | Experimental | Drug: Etripamil NSPatients will be administered by study site personnel |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Patients will be eligible for study participation if they meet all of the following criteria at screening:
- Male or female patients
- Body mass index (BMI) between the 5th and the 85th percentiles interpreted relative sex and age
- History of PSVT documented by ECG or other monitoring modality (e.g., Holter monitor, event recorder) showing SVT involving the Atrioventricular (AV) node (i.e., Atrioventricular nodal reentry tachycardia (AVNRT) or Atrioventricular reentrant tachycardia (AVRT)). If patient had a prior ablation for PSVT, patient must have documented evidence of PSVT post-ablation
- Signed written informed consent/assent obtained
Key exclusion criteria (22 listed)
- History or presence of any of the following at the screening visit:
- Evidence of impaired liver function (alanine aminotransferase [ALT] and/or aspartate aminotransferase [AST] >3 x upper limit of normal for age and gender) at the Screening Visit
- Evidence of End-Stage Renal Disease as determined by an estimated glomerular filtration rate assessed at the Screening Visit of <15 mL/min/1.73m2, or requiring hemodialysis;
- Treatment with any of the following that cannot or will not be discontinued during study participation:
- Known hypersensitivity to verapamil or to any of the excipients of the study drug
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 NSPart 1A: At least 12 patients will be administered with Etripamil NS (35 mg/100 μL per nostril) at a dose of 70 mg. Part 1B: At least 18 following patients will be administered with Etripamil NS at a dose determined by analysis of data generated from Part 1A. Part 2A: At least 12 patients will be administered with Etripamil NS at a dose selected based on appropriate body size-based modeling using PK assessments, as well as safety/tolerability, and efficacy data collected in Part 1. Part 2B: At least 18 following patients will be administered with Etripamil NS at a dose determined by analysis of data generated from Part 2A. | Drug | Etripamil NS 70mg |
Primary outcome
Efficacy: The percentage of patients converting to sinus rhythm (SR) in the first 15 minutes after administration of etripamil NS.
Time frame: 15 minutes after administration of etripamil NS
A successful conversion is defined as conversion of PSVT to SR that is maintained for at least 30 seconds
6 secondary outcomes
Efficacy: Time to termination of the PSVT episode and conversion to SR
Time frame: 60 minutes after administration of etripamil NS
Efficacy: Percentage of patients requiring additional medical intervention treatment for the PSVT episode in the first 15 minutes after study drug administration.
Time frame: 15 minutes after administration of etripamil NS
Safety: Frequency of AEs
Time frame: Until 5 days after administration of etripamil NS
Safety: Local (administration site) tolerability
Time frame: Until 5 days after administration of etripamil NS
Safety: Post-dose changes in vital signs (Hearth rate (HR))
Time frame: Until 5 days after administration of etripamil NS
Safety: Post dose changes in vital sign (Blood Pressure (BP))
Time frame: Until 5 days after administration of etripamil NS
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
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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.
David Bharucha, MD study director
Milestone Pharmaceuticals
10 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Etripamil NS in people with Paroxysmal Supraventricular Tachycardia, run by Milestone Pharmaceuticals Inc. at 10 sites in 4 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 11 inclusion and 22 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: looking for participants now, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Spain, Canada, Germany. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cameron Szakacs, PhD (704-807-6520, cszakacs@milestonepharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy: The percentage of patients converting to sinus rhythm (SR) in the first 15 minutes after administration of etripamil NS. (time frame: 15 minutes after administration of etripamil NS). 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 21 Jul 2026.