Trial · NCT03635996
Safety Study of Intranasal Etripamil for the Termination of Spontaneous Episodes of Paroxysmal Supraventricular Tachycardia (PSVT). NODE-302
NCT03635996, Phase 3, Terminated, Milestone Pharmaceuticals Inc.; results first posted 2023-04-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety Study of Intranasal Etripamil for the Termination of Spontaneous Episodes of Paroxysmal Supraventricular Tachycardia (PSVT). NODE-302. Trials, record NCT03635996. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03635996
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety Study of Intranasal Etripamil for the Termination of Spontaneous Episodes of Paroxysmal Supraventricular Tachycardia (PSVT). NODE-302
- NCT number
- NCT03635996
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 169 participants, actual
- Lead sponsor
- Milestone Pharmaceuticals Inc.
- Conditions
- Paroxysmal Supraventricular Tachycardia
- Interventions
- Etripamil NS 70 mg, Aptar Pharma Nasal Spray Bidose System
- First posted
- 2018-08-17
- Last updated
- 2024-11-05
- Results first posted
- 2023-04-24
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Conversion of an Episode of PSVT to Sinus Rhythm (SR) After Study Drug Administration. | 18 months | The efficacy analyses were performed on the Efficacy Population. The primary efficacy variable was the time to conversion of an episode of PSVT to SR after study drug administration. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Conversion of an Episode of PSVT to Sinus Rhythm (SR) After Study Drug Administration. | 18 months | Primary analysis of the primary efficacy endpoint for each patient's first episode of PSVT confirmed by adjudication and treated with etripamil NS 70 mg. There were 92 patients who had a PSVT episode that was confirmed by adjudication and were included in the primary analysis. | minutes | MEDIAN |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Conversion of an Episode of PSVT to Sinus Rhythm (SR) After Study Drug Administration. | Etripamil NS 70 mg | 21.1 | 95% Confidence Interval 11.6 to 35.5 | minutes |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Etripamil NS 70 mg | 169 | |
| Overall Study | Patients Not Treated With Etripamil | Etripamil NS 70 mg | 64 | |
| Overall Study | Safety Population | Etripamil NS 70 mg | 105 | |
| Overall Study | Efficacy Population | Etripamil NS 70 mg | 92 | |
| Overall Study | COMPLETED | Etripamil NS 70 mg | 2 | |
| Overall Study | NOT COMPLETED | Etripamil NS 70 mg | 167 |
Source ClinicalTrials.gov
Adverse events25
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 | Nasal discomfort | Respiratory, thoracic and mediastinal disorders | Etripamil NS 70 mg | 23 | 105 | |
| other | Nasal congestion | Respiratory, thoracic and mediastinal disorders | Etripamil NS 70 mg | 17 | 105 | |
| other | Rhinorrhea | Respiratory, thoracic and mediastinal disorders | Etripamil NS 70 mg | 16 | 105 | |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | Etripamil NS 70 mg | 5 | 105 | |
| other | Sneezing | Respiratory, thoracic and mediastinal disorders | Etripamil NS 70 mg | 5 | 105 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Etripamil NS 70 mg | 2 | 105 | |
| other | Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Etripamil NS 70 mg | 2 | 105 | |
| other | Headache | Nervous system disorders | Etripamil NS 70 mg | 5 | 105 | |
| other | Dizziness | Nervous system disorders | Etripamil NS 70 mg | 4 | 105 | |
| other | Paresthesia | Nervous system disorders | Etripamil NS 70 mg | 2 | 105 |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Etripamil NS 70 mg | 0 | 105 |
| Total, other adverse events | Etripamil NS 70 mg | 67 | 105 |
| Total, serious adverse events | Etripamil NS 70 mg | 8 | 105 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37753718 | DERIVED |
Source PubMed
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT03635996
GET https://conductscience.org/api/trials/v1/NCT03635996/events?page=2