Trial · NCT05763953
The NODE-202 Study (Study of Etripamil Nasal Spray in Pediatric Patients)
NCT05763953, Phase 2, Recruiting, Milestone Pharmaceuticals Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The NODE-202 Study (Study of Etripamil Nasal Spray in Pediatric Patients). Trials, record NCT05763953. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05763953
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The NODE-202 Study (Study of Etripamil Nasal Spray in Pediatric Patients)
- NCT number
- NCT05763953
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 60 participants, estimated
- Lead sponsor
- Milestone Pharmaceuticals Inc.
- Conditions
- Paroxysmal Supraventricular Tachycardia
- Interventions
- Etripamil NS
- First posted
- 2023-03-10
- Last updated
- 2026-07-21
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Efficacy: The percentage of patients converting to sinus rhythm (SR) in the first 15 minutes after administration of etripamil NS. | 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 |
| Secondary | Efficacy: Time to termination of the PSVT episode and conversion to SR | 60 minutes after administration of etripamil NS | Time measured from time of dosing to time of conversion of PSVT to SR that is maintained for at least 30 seconds |
| Secondary | Efficacy: Percentage of patients requiring additional medical intervention treatment for the PSVT episode in the first 15 minutes after study drug administration. | 15 minutes after administration of etripamil NS | Medical intervention is defined as an administered drug or procedure to treat PSVT |
| Secondary | Safety: Frequency of AEs | Until 5 days after administration of etripamil NS | Adverse Events (AEs) defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related |
| Secondary | Safety: Local (administration site) tolerability | Until 5 days after administration of etripamil NS | Local tolerability defined as frequency of adverse events related to nasal spray site administration |
| Secondary | Safety: Post-dose changes in vital signs (Hearth rate (HR)) | Until 5 days after administration of etripamil NS | HR changes as measured by increase/decrease in beats per minute |
| Secondary | Safety: Post dose changes in vital sign (Blood Pressure (BP)) | Until 5 days after administration of etripamil NS | BP changes (systolic blood pressure (SBP) and diastolic blood pressure (DBP)) as measured in increase/decrease in mmHg |
| Other | Pharmacokinetic analysis of etripamil: Maximum plasma concentration (Cmax) | Within 1 hour after administration of etripamil NS | Maximum plasma concentration (Cmax) in ng/mL of etripamil assessed from PK analysis of plasma samples within 1 hour of dosing. |
| Other | Pharmacokinetic analysis of etripamil: Area under the concentration-time curve from dosing (time 0) to time t (AUC0-t). | Within 1 hour after administration of etripamil NS | Area under the concentration-time curve from dosing (time 0) to time t (AUC0-t) in min\*ng/mL of etripamil assessed from PK analysis of plasma samples within 1 hour of dosing. |
| Other | Pharmacokinetic analysis of etripamil: Area under the concentration-time curve from dosing (time 0) to time infinity (AUC0-inf). | Within 1 hour after administration of etripamil NS | Area under the concentration-time curve from dosing (time 0) to time infinity (AUC0-inf) in min\*ng/mL of etripamil assessed from PK analysis of plasma samples within 1 hour of dosing. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT05763953
GET https://conductscience.org/api/trials/v1/NCT05763953/registered