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

NCT03635996 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 169

Last updated 2024-11-05

Study results available
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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).

Conditions

  • Paroxysmal Supraventricular Tachycardia

Interventions

DRUG

Etripamil NS 70 mg

All patients will receive a total of 200 micro-liters of etripamil NS 70 mg via the Aptar Pharma Nasal Spray Bidose System each time they self-administer study drug.

DEVICE

Aptar Pharma Nasal Spray Bidose System

Patients will self-administer the study drug using the Aptar Pharma Nasal Spray Bidose System. The devices will be prefilled and packaged into child-resistant boxes.Instructions for its use will be provided in the study drug box.

Sponsors & Collaborators

  • Medpace, Inc.

    collaborator INDUSTRY

  • Milestone Pharmaceuticals Inc.

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-10
Primary Completion
2020-11-13
Completion
2020-11-13
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03635996 on ClinicalTrials.gov