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NCT03635996 · ClinicalTrials.gov registry record · Phase 3

Safety Study of Intranasal Etripamil for the Termination of Spontaneous Episodes of Paroxysmal Supraventricular Tachycardia (PSVT). NODE-302

A Phase 3 study, sponsored by Milestone Pharmaceuticals.

Terminated
Registry status
Phase 3
Development phase
169
Enrollment target

NCT03635996: Clinical Trial Phase 3 study, sponsored by Milestone Pharmaceuticals.

NCT03635996 is a Phase 3 study that was terminated before completion, run by Milestone Pharmaceuticals. The registered enrollment target is 169 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03635996, a Phase 3 study, was terminated before completion, sponsored by Milestone Pharmaceuticals.

TERMINATED
Registry status
Phase 3
Development phase
169 participants
Enrollment target

Study Summary

The primary objective of this study is to evaluate the safety of etripamil nasal spray (NS) 70 mg when self-administered by patients with an episode of Paroxysmal Supraventricular Tachycardia in an outpatient setting (i.e., without medical supervision).

Primary Outcome

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.

Interventions

  • DRUG Etripamil NS 70 mg
  • DEVICE Aptar Pharma Nasal Spray Bidose System

Trial Details

FieldValue
Enrollment Target 169 participants
Start Date 2018-12-10
Est. Completion 2020-11-13
Phase Phase 3
Milestone Pharmaceuticals

7 total trials

Why NCT03635996 stopped before completion

NCT03635996 is an interventional study that assigns participants to a tested intervention. The registered 169 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower).

The record links to 0 conditions, and to 2 interventions - of which Etripamil NS 70 mg is the first listed.

NCT03635996 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03635996 about?

NCT03635996 is a clinical study titled "Safety Study of Intranasal Etripamil for the Termination of Spontaneous Episodes of Paroxysmal Supraventricular Tachycardia (PSVT). NODE-302". The primary objective of this study is to evaluate the safety of etripamil nasal spray (NS) 70 mg when self-administered by patients with an episode of Paroxysmal Supraventricular Tachycardia in an outpatient setting (i.e., without medical supervision).

What is the current status of trial NCT03635996?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 169 participants. The study started on 2018-12-10. Estimated completion is 2020-11-13.

What interventions are being tested in trial NCT03635996?

The interventions under investigation include: Etripamil NS 70 mg (DRUG), Aptar Pharma Nasal Spray Bidose System (DEVICE).

Who is sponsoring clinical trial NCT03635996?

This trial is sponsored by Milestone Pharmaceuticals, which has 7 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03635996's enrollment target sits among peer trials

169 1459th of 2000 higher than 542 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03635996, the US trial registry maintained by the National Library of Medicine. NCT03635996 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.