Trial · NCT04072835
Safety Study of Etripamil Nasal Spray for Patients With Paroxysmal Supraventricular Tachycardia. NODE-303
NCT04072835, Phase 3, Completed, Milestone Pharmaceuticals Inc.; results first posted 2024-05-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety Study of Etripamil Nasal Spray for Patients With Paroxysmal Supraventricular Tachycardia. NODE-303. Trials, record NCT04072835. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04072835
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety Study of Etripamil Nasal Spray for Patients With Paroxysmal Supraventricular Tachycardia. NODE-303
- NCT number
- NCT04072835
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,116 participants, actual
- Lead sponsor
- Milestone Pharmaceuticals Inc.
- Conditions
- Paroxysmal Supraventricular Tachycardia
- Interventions
- Etripamil NS
- First posted
- 2019-08-28
- Last updated
- 2024-05-23
- Results first posted
- 2024-05-23
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events for Self-administered Etripamil NS Outside of the Clinical Setting. | From Baseline until a maximum of 4 episodes of perceived PSVT are treated with study drug, up to a maximum duration of 40 months. | Number of participants with any adverse events experienced from baseline up to the final study visit including the treatment of up to 4 perceived PSVT episodes. |
| Secondary | Time to Conversion | Time to conversion up to 60 minutes after etripamil administration. | Kaplan-Meier estimates of time to conversion up to 60 minutes after etripamil administration for adjudicated conversion of confirmed episodes of PSVT to SR (Sinus Rhythm) reported at Follow-up Visit 1. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events for Self-administered Etripamil NS Outside of the Clinical Setting. | From Baseline until a maximum of 4 episodes of perceived PSVT are treated with study drug, up to a maximum duration of 40 months. | The Safety Population includes all participants who self-administered any amount of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Conversion | Time to conversion up to 60 minutes after etripamil administration. | The Efficacy Population includes participants who received study drug for an event confirmed as PSVT by the Sponsor's medical review of the ECG CMS data. | minutes | MEDIAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events for Self-administered Etripamil NS Outside of the Clinical Setting. | Etripamil | 324 | Participants | ||
| Time to Conversion | Etripamil | 17.7 | 95% Confidence Interval 13.9 to 26.2 | minutes |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | All Participants | 1,116 | |
| Overall Study | Participants Who Completed the Study With at Least 1 Treated Perceived PSVT Episode | All Participants | 503 | |
| Overall Study | Participants Who Treated 1 Perceived PSVT Episode in the Study | All Participants | 220 | |
| Overall Study | Participants Who Treated 2 Perceived PSVT Episodes in the Study | All Participants | 118 | |
| Overall Study | Participants Who Treated 3 Perceived PSVT Episodes in the Study | All Participants | 62 | |
| Overall Study | Participants Who Treated 4 Perceived PSVT Episodes in the Study | All Participants | 103 | |
| Overall Study | COMPLETED | All Participants | 103 | |
| Overall Study | NOT COMPLETED | All Participants | 1,013 |
Source ClinicalTrials.gov
Adverse events116
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | Etripamil | 28 | 503 | 40 |
| other | Headache | Nervous system disorders | Not Treated | 4 | 613 | 5 |
| other | Nasal discomfort | Respiratory, thoracic and mediastinal disorders | Etripamil | 153 | 503 | 235 |
| other | Nasal discomfort | Respiratory, thoracic and mediastinal disorders | Not Treated | 0 | 613 | 0 |
| other | Nasal congestion | Respiratory, thoracic and mediastinal disorders | Etripamil | 72 | 503 | 96 |
| other | Nasal congestion | Respiratory, thoracic and mediastinal disorders | Not Treated | 1 | 613 | 1 |
| other | Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Etripamil | 68 | 503 | 98 |
| other | Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Not Treated | 1 | 613 | 1 |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | Etripamil | 41 | 503 | 49 |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | Not Treated | 0 | 613 | 0 |
1 to 10 of 116Source ClinicalTrials.gov
See all 116 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Etripamil | 4 | 503 |
| Total, all-cause mortality | Not Treated | 7 | 613 |
| Total, other adverse events | Etripamil | 237 | 503 |
| Total, other adverse events | Not Treated | 32 | 613 |
| Total, serious adverse events | Etripamil | 34 | 503 |
| Total, serious adverse events | Not Treated | 22 | 613 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Etripamil vs Not Treated: deaths from any cause | Trial comparisons |
| Etripamil vs Not Treated: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04072835
GET https://conductscience.org/api/trials/v1/NCT04072835/events?page=2