A Phase 3 interventional study of Etripamil and Placebo in Paroxysmal Supraventricular Tachycardia, sponsored by Milestone Pharmaceuticals Inc.. Terminated at 161 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-12.
Sponsored by Milestone Pharmaceuticals Inc. · Phase 3, Interventional, and Treatment
Among 154 studies in Tachycardia, Ventricular with a site in United States — 34 open to participants now, 40 under way, 2 of them phase 3. Tachycardia, Ventricular · United States.
Among the 154 studies in Tachycardia, Ventricular with a site in United States, this one is the 5th largest by enrollment of the 107 interventional ones that give a count, is one of 13 that started in 2018, is one of 13 in phase 3, and was the 81st registered.
452 studies on the registry are indexed under Tachycardia, Ventricular; 121 are open to participants now.
Browse Tachycardia, Ventricular studies →34 of the 154 studies in Tachycardia, Ventricular with a site in United States are open now. Recruiting first, the newest first:
Medtronic Cardiac Ablation Solutions · Sites in United States
Ages 18–85
Adagio Medical · Sites in United States, Canada
Ages 18+
AtaCor Medical, Inc. · Sites in United States, Netherlands
Ages 18+
Cardurion Pharmaceuticals, Inc. · Sites in United States, Canada, France and 3 more countries
Ages 18–99
Thermedical, Inc. · Sites in United States, Canada
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 86 Tachycardia, Ventricular studies recruiting now, 67 (78%) set no upper age limit and 1 (1%) stops at 75 or younger; 7 take children under 18; 5 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
154 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 6 · Phase 2 13 · Phase 3 15 · Phase 4 8
First in 1995; this study’s year is marked. 13 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 1,097 is above the median of 70 across 281 interventional studies indexed under Tachycardia, Ventricular.
Median enrollment 60 across the 107 interventional studies, 142 across the 47 observational. Of the 99 that completed or were terminated, 51 (52%) have results posted.
This tab as a report to print or save as PDF → With an account.
52 of 154 have an industry lead sponsor. The 10 most frequent:
Milestone Pharmaceuticals Inc. is the lead sponsor of 9 studies on the registry; 2 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Milestone Pharmaceuticals Inc. has 7 studies filed under Tachycardia, Ventricular — fewer than ten, so there is no comparison to draw.
13 of the studies in Tachycardia, Ventricular with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06281977Phase 3Ottawa Heart Institute Research CorporationStudy Evaluating Dexmedetomidine in the Acute Treatment of Electrical Storm | 2027-05-08 |
| NCT06703489Medtronic Cardiac Ablation SolutionsSafety and Performance Assessment of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere-9 VT EFS) | 2026-11 |
| NCT06138873Rush University Medical CenterAblation-Index Guided Scar-Mediated Ventricular Tachycardia Ablation in Patients With Ischemic Cardiomyopathy | 2026-11-23 |
| NCT04520347University of California, Los AngelesIVTCC 2.0: A Prospective Multicenter Ventricular Tachycardia Catheter Ablation Registry | 2026-12 |
| NCT06747013Vivek ReddyTreatment of Focal Ventricular Tachycardias Using a Pulsed Field Ablation From a Point Ablation Catheter Short Title FOCUS-PFA | 2027-02 |
Add all 13 to your calendar (.ics) → With an account.
Among the 154 studies in Tachycardia, Ventricular with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This was a three-part, multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of etripamil nasal spray (NS) self-administered by participants who experienced an episode of paroxysmal supraventricular tachycardia (PSVT) in an at-home setting.
NODE-301 Part 1 included participants that received the randomized study drug to treat an episode of PSVT until the 150th positively adjudicated PSVT episode. Part 2 (also referred as the RAPID study) included participants that did not receive the randomized study drug in Part 1 and newly enrolled participants until the 180th positively adjudicated PSVT episode in Part 2. The study continued for approximately 6 months after the 180th positively adjudicated PSVT episode in Part 2 and this extension is referred to as Part 3 (also referred to as RAPID Extension).
NODE-301 was a three-part, multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of etripamil NS self-administered by participants who experienced an episode of PSVT in an at-home setting. Each episode was documented by an ambulatory Cardiac Monitoring System (CMS) that was placed on the chest by the participants or caregiver when symptoms begin and recorded at least 5 hours of continuous electrocardiogram (ECG).
This was an event-driven study. The study comprised of three parts: Parts 1, 2, and 3.
NODE-301 Part 1 included participants that received the randomized study drug to treat an episode of PSVT until the 150th positively adjudicated PSVT episode (January 15th, 2020). Participants were randomized to etripamil 70 mg or placebo in a 2:1 ratio. Participants had a Test Dose Randomization Visit where they received 70 mg etripamil in sinus rhythm and a Treatment Period during which they could administer the randomized study drug during a perceived episode of PSVT.
Part 2 (also referred as the RAPID study) included participants that did not use the randomized study drug to treat a perceived episode of PSVT before the Part 1 data cutoff and newly enrolled participants. Before randomization in the RAPID study, all participants received a Test Dose of etripamil consisting of an initial dose of etripamil 70 mg followed by a second dose of etripamil 70 mg 10 minutes later to evaluate tolerability and to train participants on the study procedures. After a successful Test Dose, participants in Part 2 were randomized to etripamil or placebo in a 1:1 ratio. When experiencing a PSVT episode, participants were instructed to administer a first dose of randomized study drug (70 mg etripamil or placebo) followed 10 minutes later, if PSVT symptoms persisted, by a second dose of study drug (70 mg etripamil or placebo). After having administered the randomized study drug for a perceived episode of PSVT, participants could enter an open-label period during which they had the possibility to treat a second episode of PSVT with open-label etripamil (70 mg etripamil with optional second dose of 70 mg etripamil).
Part 2 continued until the 180th positively adjudicated PSVT episode (the data on which the primary efficacy analysis of RAPID was conducted) (July 20th 2022). The study continued for approximately 6 months after the 180th positively adjudicated PSVT episode in Part 2 and this extension is referred to as Part 3 (also referred to as RAPID Extension). The design of Parts 2 and 3 were the same and therefore their results are combined in this publication.
NODE-301 study comprised 6 arms:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants who met all of the following criteria were eligible to participate in the study:
Females of who were sexually active with a male partner who were not surgically sterile (i.e., vasectomy) had to agree to use a highly effective form of from the time of signed until 30 days after the last administration of study drug. Females of childbearing potential had to have a negative serum pregnancy test result at the Screening Visit and at the Final Study Visit, a negative urine pregnancy test at the Test Dose Randomization Visit and had to use a highly effective form of contraception between the visits.
The following categories defined females who were NOT considered to be of childbearing potential:
Premenopausal females with 1 of the following:
Exclusion Criteria:
Participants who met any of the following criteria were excluded from participation in the study:
Before randomization in the study, all participants received a Test Dose of an etripamil NS dosing regimen (etripamil 70 NS mg in Part 1 and in Parts 2 and 3 an initial dose of etripamil NS 70 mg followed by a second dose of etripamil NS 70 mg not earlier than 10 minutes and not later than 15 minutes after the first dose) to evaluate tolerability and to train participants on the study procedures. Participants who passed the Test Dose were randomized in the NODE-301 (2:1) or RAPID and RAPID Extension (2:1) study. A failure of the Test Dose was considered if participants met any of the following criteria occurring after administration of the either the first or second dose of etripamil NS 70 mg:
For participants with a pre-Test Dose Systolic Blood Pressure above 100 mmHg:
For participants with a pre-Test Dose SBP between 90 mmHg and 100 mmHg (inclusive):
a) Post-Test Dose SBP \<75 mmHg;
Participants who failed the Test Dose proceeded in the study as follows:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Self-administration of a single dose etripamil 70 mg for a perceived episode of PSVT.
Drug: Etripamil
Self-administration of a single dose of placebo for a perceived episode of PSVT.
Drug: Placebo
Single test dose of etripamil 70 mg in sinus rhythm
Drug: Etripamil Test Dose
Self-administration of 70 mg etripamil for a perceived episode of PSVT followed 10 minutes later by an optional second dose of 70 mg etripamil, if symptoms persisted. Participants could be enrolled in the open-label period to treat an additional PSVT episode with etripamil.
Drug: Etripamil
Self-administration of placebo for a perceived episode of PSVT followed 10 minutes later by an optional second dose of placebo, if symptoms persisted. Participants could be enrolled in the open-label period to treat an additional PSVT episode with etripamil.
Drug: Placebo
Repeat Test Dose of etripamil 70 mg (2X 70mg) 10 minutes apart in sinus rhythm
Drug: Etripamil Test Dose
Etripamil administered via the Aptar Pharma Nasal Spray Bidose System, supplied as prefilled devices packaged into child-resistant boxes with instructions for use provided in the study drug box.
Also known as: MSP-2017
Placebo administered via the Aptar Pharma Nasal Spray Bidose System, supplied as prefilled devices packaged into child-resistant boxes with instructions for use provided in the study drug box.
During the Test Dose, etripamil administered via the Aptar Pharma Nasal Spray Bidose System, supplied as prefilled devices packaged into child-resistant boxes with instructions for use provided in the study drug box.
Also known as: MSP-2017 Test Dose
The Time to Conversion of an Episode of PSVT to Sinus Rhythm (SR) After Study Drug Administration.
The primary efficacy endpoint is defined as an adjudicated termination of a positively adjudicated episode of PSVT (AV nodal reentrant tachycardia or AV reentrant tachycardia determination if possible) and conversion to sinus rhythm (SR) for at least 30 seconds within 5 hours (NODE-301 Part 1), or 30 minutes (NODE-301 Parts 2 and 3) of start of study drug dosing.
Time frame: NODE-301 Part 1: Within 5 hours of start of study drug dosing. NODE-301 Parts 2 and 3: Within 30 minutes of start of study drug dosing.
431 participants enrolled in Part 1 until the 150th positively adjudicated PSVT episode (15-Jan-2020). After the Part 1 cutoff, 82 participants enrolled in Part 1 transitioned to Part 2 in addition to 624 newly enrolled participants until the 180th positively adjudicated PSVT in Part 2 (20-Jul-2022). The study continued for about 6 months (Part 3) after the Part 2 cutoff with participants waiting for a PSVT episode to arise and 42 newly enrolled participants (27-Feb-2023).
| Milestone | Placebo | Etripamil | Test Dose Only |
|---|---|---|---|
| Started | 60 | 138 | 233 |
| Participants randomized | 60 | 138 | 233 |
| Participants in efficacy population | 49 | 107 | 0 |
| Completed | 60 | 138 | 0 |
| Not completed | 0 | 0 | 233 |
| Withdrew: Withdrawal by subject | 0 | 0 | 18 |
| Withdrew: Ablation | 0 | 0 | 16 |
| Withdrew: Test dose failure | 0 | 0 | 8 |
| Withdrew: Adverse event | 0 | 0 | 5 |
| Withdrew: Physician decision | 0 | 0 | 4 |
| Withdrew: Lost to follow-up | 0 | 0 | 3 |
| Withdrew: Protocol violation | 0 | 0 | 2 |
| Withdrew: Reason was not provided by the participant | 0 | 0 | 15 |
| Withdrew: Transitioned to part 2 (rapid) | 0 | 0 | 82 |
| Withdrew: Participants did not experienced psvt before cutoff and did not enroll in part 2 | 0 | 0 | 80 |
| Milestone | Placebo | Etripamil | Test Dose Only |
|---|---|---|---|
| Started | 143 | 160 | 445 |
| Participants randomized | 143 | 160 | 445 |
| Participants in efficacy population | 100 | 114 | 0 |
| Completed | 76 | 81 | 0 |
| Not completed | 67 | 79 | 445 |
| Withdrew: Withdrawal by subject | 5 | 1 | 32 |
| Withdrew: Ablation | 8 | 11 | 46 |
| Withdrew: Test dose failure | 0 | 0 | 8 |
| Withdrew: Adverse event | 1 | 3 | 14 |
| Withdrew: Physician decision | 0 | 0 | 2 |
| Withdrew: Lost to follow-up | 1 | 0 | 7 |
| Withdrew: Protocol violation | 0 | 1 | 2 |
| Withdrew: Pregnancy | 0 | 0 | 1 |
| Withdrew: Prohibited medication | 1 | 1 | 4 |
| Withdrew: Study terminated by sponsor | 46 | 61 | 314 |
| Withdrew: Reason was not provided by the participant | 5 | 1 | 15 |
The primary efficacy endpoint is defined as an adjudicated termination of a positively adjudicated episode of PSVT (AV nodal reentrant tachycardia or AV reentrant tachycardia determination if possible) and conversion to sinus rhythm (SR) for at least 30 seconds within 5 hours (NODE-301 Part 1), or 30 minutes (NODE-301 Parts 2 and 3) of start of study drug dosing.
| Participants | Part 1 - Placebo Single Dose | Part 1 - Etripamil 70 mg | Parts 2 and 3 - Placebo With Optional Second Dose of Placebo | Parts 2 and 3 - Etripamil 70 mg With Optional Second Dose of Etripamil 70 mg |
|---|---|---|---|---|
| Part 1: Participants converted to sinus rhythm within 5 hours | 36 | 80 | — | — |
| Part 1: Participants censored | 13 | 27 | — | — |
| Parts 2 and 3: Participants converted to sinus rhythm within 30 minutes | — | — | 30 | 75 |
| Parts 2 and 3: Participants censored | — | — | 70 | 39 |
Collected over Average of 9.4 months, adverse events were monitored from the time of test dose administration (i.e.,Test Dose Randomization Visit) until study participation was completed (i.e., after the Final Study Visit).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Part 1 - Placebo Single Dose | 0/60 (0%) | 1/60 (1.7%) | 39/60 (65%) |
| Part 1 - Etripamil 70 mg | 0/138 (0%) | 1/138 (0.7%) | 98/138 (71%) |
| Part 1 - Test Dose Only | 0/233 (0%) | 4/233 (1.7%) | 151/233 (64.8%) |
| Parts 2 and 3 - Placebo With Optional Second Dose of Placebo + Open-label Etripamil | 0/143 (0%) | 3/143 (2.1%) | 114/143 (79.7%) |
| Parts 2 and 3 - Etripamil 70 mg With Optional Second Dose of Etripamil 70 mg + Open-label Etripamil | 0/160 (0%) | 2/160 (1.3%) | 127/160 (79.4%) |
| Parts 2 and 3 - Test Dose Only (2X70 mg) | 1/445 (0.2%) | 18/445 (4%) | 324/445 (72.8%) |
| Event | Part 1 - Placebo Single Dose | Part 1 - Etripamil 70 mg | Part 1 - Test Dose Only | Parts 2 and 3 - Placebo With Optional Second Dose of Placebo + Open-label Etripamil | Parts 2 and 3 - Etripamil 70 mg With Optional Second Dose of Etripamil 70 mg + Open-label Etripamil | Parts 2 and 3 - Test Dose Only (2X70 mg) |
|---|---|---|---|---|---|---|
| Non-cardiac chest painGeneral disorders | 1/60 | 0/138 | 0/233 | 0/143 | 0/160 | 1/445 |
| Intestinal obstructionGastrointestinal disorders | 0/60 | 1/138 | 0/233 | 0/143 | 0/160 | 0/445 |
| Acute myocardial infarctionCardiac disorders | 0/60 | 0/138 | 0/233 | 1/143 | 0/160 | 1/445 |
| Invasive ductal breast carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/60 | 0/138 | 0/233 | 1/143 | 0/160 | 0/445 |
| Acute kidney injuryRenal and urinary disorders | 0/60 | 0/138 | 0/233 | 1/143 | 0/160 | 0/445 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 0/60 | 0/138 | 0/233 | 0/143 | 0/160 | 3/445 |
| Supraventricular tachycardiaCardiac disorders | 0/60 | 0/138 | 0/233 | 0/143 | 1/160 | 0/445 |
| Corona virus infectionInfections and infestations | 0/60 | 0/138 | 0/233 | 0/143 | 1/160 | 1/445 |
| FaecalomaGastrointestinal disorders | 0/60 | 0/138 | 0/233 | 0/143 | 0/160 | 2/445 |
| CellulitisInfections and infestations | 0/60 | 0/138 | 1/233 | 0/143 | 0/160 | 2/445 |
| Event | Part 1 - Placebo Single Dose | Part 1 - Etripamil 70 mg | Part 1 - Test Dose Only | Parts 2 and 3 - Placebo With Optional Second Dose of Placebo + Open-label Etripamil | Parts 2 and 3 - Etripamil 70 mg With Optional Second Dose of Etripamil 70 mg + Open-label Etripamil | Parts 2 and 3 - Test Dose Only (2X70 mg) |
|---|---|---|---|---|---|---|
| Nasal discomfortRespiratory, thoracic and mediastinal disorders | 15/60 | 55/138 | 98/233 | 58/143 | 70/160 | 139/445 |
| RhinorrhoeaRespiratory, thoracic and mediastinal disorders | 8/60 | 24/138 | 26/233 | 31/143 | 42/160 | 77/445 |
| Nasal congestionRespiratory, thoracic and mediastinal disorders | 8/60 | 23/138 | 29/233 | 30/143 | 42/160 | 59/445 |
| Lacrimation increasedEye disorders | 9/60 | 8/138 | 24/233 | 28/143 | 30/160 | 74/445 |
| Throat irritationRespiratory, thoracic and mediastinal disorders | 3/60 | 23/138 | 20/233 | 21/143 | 31/160 | 54/445 |
| SneezingRespiratory, thoracic and mediastinal disorders | 4/60 | 11/138 | 10/233 | 14/143 | 19/160 | 38/445 |
| EpistaxisRespiratory, thoracic and mediastinal disorders | 1/60 | 16/138 | 13/233 | 14/143 | 18/160 | 27/445 |
| HeadacheNervous system disorders | 1/60 | 11/138 | 11/233 | 9/143 | 13/160 | 38/445 |
| Corona virus infectionInfections and infestations | 0/60 | 0/138 | 0/233 | 6/143 | 11/160 | 35/445 |
| Supraventricular tachycardiaCardiac disorders | 0/60 | 0/138 | 0/233 | 11/143 | 5/160 | 8/445 |
Data presented for the overall safety population including participants that received at least one dose of study drug.
| Age, Continuous(years) | Part 1 - Placebo Single Dose | Part 1 - Etripamil 70 mg | Part 1 - Test Dose Only | Parts 2 and 3 - Placebo With Optional Second Dose of Placebo | Parts 2 and 3 - Etripamil 70 mg With Optional Second Dose of Etripamil 70 mg | Parts 2 and 3 - Test Dose Only (2X70 mg) | Total |
|---|---|---|---|---|---|---|---|
| Part 1 | 55.0 ± 14.96 | 57.2 ± 13.58 | 54.1 ± 15.59 | — | — | — | 55.2 ± 14.92 |
| Parts 2 and 3 | — | — | — | 55.9 ± 12.5 | 52.2 ± 13.9 | 53.9 ± 14.9 | 53.9 ± 14.1 |
| Age, Customized(years) | Part 1 - Placebo Single Dose | Part 1 - Etripamil 70 mg | Part 1 - Test Dose Only | Parts 2 and 3 - Placebo With Optional Second Dose of Placebo | Parts 2 and 3 - Etripamil 70 mg With Optional Second Dose of Etripamil 70 mg | Parts 2 and 3 - Test Dose Only (2X70 mg) | Total |
|---|---|---|---|---|---|---|---|
| Part 1: Age at confirmation of PSVT (years) | 53.8 ± 15.03 | 56.3 ± 13.69 | 53.2 ± 15.72 | — | — | — | 54.3 ± 15.03 |
| Parts 2 and 3: Age at confirmation of PSVT (years) | — | — | — | 54.9 ± 12.9 | 50.4 ± 14.5 | 52.5 ± 14.6 | 52.5 ± 14.3 |
| Sex: Female, Male(Participants) | Part 1 - Placebo Single Dose | Part 1 - Etripamil 70 mg | Part 1 - Test Dose Only | Parts 2 and 3 - Placebo With Optional Second Dose of Placebo | Parts 2 and 3 - Etripamil 70 mg With Optional Second Dose of Etripamil 70 mg | Parts 2 and 3 - Test Dose Only (2X70 mg) | Total |
|---|---|---|---|---|---|---|---|
| Part 1 — Female | 39 | 92 | 142 | — | — | — | 273 |
| Part 1 — Male | 21 | 46 | 91 | — | — | — | 158 |
| Parts 2 and 3 — Female | — | — | — | 100 | 112 | 268 | 480 |
| Parts 2 and 3 — Male | — | — | — | 43 | 48 | 177 | 268 |
| Ethnicity (NIH/OMB)(Participants) | Part 1 - Placebo Single Dose | Part 1 - Etripamil 70 mg | Part 1 - Test Dose Only | Parts 2 and 3 - Placebo With Optional Second Dose of Placebo | Parts 2 and 3 - Etripamil 70 mg With Optional Second Dose of Etripamil 70 mg | Parts 2 and 3 - Test Dose Only (2X70 mg) | Total |
|---|---|---|---|---|---|---|---|
| Part 1 — Hispanic or Latino | 0 | 5 | 5 | — | — | — | 10 |
| Part 1 — Not Hispanic or Latino | 56 | 129 | 220 | — | — | — | 405 |
| Part 1 — Unknown or Not Reported | 4 | 4 | 8 | — | — | — | 16 |
| Parts 2 and 3 — Hispanic or Latino | — | — | — | 12 | 11 | 50 | 73 |
| Parts 2 and 3 — Not Hispanic or Latino | — | — | — | 129 | 147 | 384 | 660 |
| Parts 2 and 3 — Unknown or Not Reported | — | — | — | 2 | 2 | 11 | 15 |
| Race (NIH/OMB)(Participants) | Part 1 - Placebo Single Dose | Part 1 - Etripamil 70 mg | Part 1 - Test Dose Only | Parts 2 and 3 - Placebo With Optional Second Dose of Placebo | Parts 2 and 3 - Etripamil 70 mg With Optional Second Dose of Etripamil 70 mg | Parts 2 and 3 - Test Dose Only (2X70 mg) | Total |
|---|---|---|---|---|---|---|---|
| Part 1 — American Indian or Alaska Native | 1 | 0 | 0 | — | — | — | 1 |
| Part 1 — Asian | 2 | 5 | 14 | — | — | — | 21 |
| Part 1 — Native Hawaiian or Other Pacific Islander | 0 | 2 | 2 | — | — | — | 4 |
| Part 1 — Black or African American | 4 | 6 | 17 | — | — | — | 27 |
| Part 1 — White | 51 | 120 | 194 | — | — | — | 365 |
| Part 1 — More than one race | 0 | 0 | 0 | — | — | — | 0 |
| Part 1 — Unknown or Not Reported | 2 | 5 | 6 | — | — | — | 13 |
| Parts 2 and 3 — American Indian or Alaska Native | — | — | — | 0 | 1 | 0 | 1 |
| Parts 2 and 3 — Asian | — | — | — | 5 | 2 | 8 | 15 |
| Parts 2 and 3 — Native Hawaiian or Other Pacific Islander | — | — | — | 0 | 0 | 1 | 1 |
| Parts 2 and 3 — Black or African American | — | — | — | 3 | 5 | 17 | 25 |
| Parts 2 and 3 — White | — | — | — | 131 | 149 | 408 | 688 |
| Parts 2 and 3 — More than one race | — | — | — | 0 | 0 | 0 | 0 |
| Parts 2 and 3 — Unknown or Not Reported | — | — | — | 4 | 3 | 11 | 18 |
| PSVT confirmation duration (years)(years) | Part 1 - Placebo Single Dose | Part 1 - Etripamil 70 mg | Part 1 - Test Dose Only | Parts 2 and 3 - Placebo With Optional Second Dose of Placebo | Parts 2 and 3 - Etripamil 70 mg With Optional Second Dose of Etripamil 70 mg | Parts 2 and 3 - Test Dose Only (2X70 mg) | Total |
|---|---|---|---|---|---|---|---|
| Part 1 | 1.7 ± 4.45 | 1.4 ± 2.39 | 1.4 ± 2.39 | — | — | — | 1.4 ± 2.76 |
| Parts 2 and 3 | — | — | — | 1.6 ± 3.6 | 2.3 ± 5.2 | 1.9 ± 4.2 | 1.9 ± 4.3 |
| Number of participant reported PSVT episodes in the past year(episodes) | Part 1 - Placebo Single Dose | Part 1 - Etripamil 70 mg | Part 1 - Test Dose Only | Parts 2 and 3 - Placebo With Optional Second Dose of Placebo | Parts 2 and 3 - Etripamil 70 mg With Optional Second Dose of Etripamil 70 mg | Parts 2 and 3 - Test Dose Only (2X70 mg) | Total |
|---|---|---|---|---|---|---|---|
| Part 1 | 12.5 ± 17.91 | 7.8 ± 7.65 | 6.6 ± 13.11 | — | — | — | 7.8 ± 12.60 |
| Parts 2 and 3 | — | — | — | 10.0 ± 21.1 | 6.8 ± 15.1 | 5.7 ± 11.3 | 6.7 ± 14.5 |
| Number of participant reported emergency department visits for PSVT in lifetime(emergency department visits) | Part 1 - Placebo Single Dose | Part 1 - Etripamil 70 mg | Part 1 - Test Dose Only | Parts 2 and 3 - Placebo With Optional Second Dose of Placebo | Parts 2 and 3 - Etripamil 70 mg With Optional Second Dose of Etripamil 70 mg | Parts 2 and 3 - Test Dose Only (2X70 mg) | Total |
|---|---|---|---|---|---|---|---|
| Part 1 | 5.0 ± 13.17 | 2.7 ± 3.69 | 2.4 ± 3.20 | — | — | — | 2.8 ± 5.87 |
| Parts 2 and 3 | — | — | — | 3.6 ± 10.3 | 4.3 ± 14.2 | 2.3 ± 5.3 | 3.0 ± 9.0 |
3 further baseline measures are reported on the registry.
Showing the first 100 of 161 sites across 9 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jun 2018 to primary completion in Jan 2023, 55 months.
Results were first posted in Jul 2024, 1 year 5 months after primary completion. A results delay was requested in Jan 2024.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in May 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Etripamil
Milestone Pharmaceuticals Inc.