Safety Study of Intranasal Etripamil for the Termination of Spontaneous Episodes of Paroxysmal Supraventricular Tachycardia (PSVT). NODE-302
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|ClinicalTrials.gov Identifier: NCT03635996|
Recruitment Status : Completed
First Posted : August 17, 2018
Last Update Posted : March 29, 2021
|Condition or disease||Intervention/treatment||Phase|
|Paroxysmal Supraventricular Tachycardia||Drug: Etripamil NS 70 mg Device: Aptar Pharma Nasal Spray Bidose System||Phase 3|
The NODE-302 study is an extension of the NODE-301 efficacy study. It is a multi-centre, open label study designed to evaluate the safety of etripamil NS 70 mg when self-administered by patients for spontaneous episodes of PSVT in an outpatient setting. All patients randomized in the NODE-301 study and who meet the inclusion and exclusion criteria of the NODE-302 study are eligible for the NODE-302 study.
After each episode of PSVT, patients will have the option to continue in the NODE-302 study and manage subsequent episodes of PSVT with etripamil NS 70 mg if they do not meet any withdrawal criteria.
Each episode of PSVT will be documented by an ambulatory cardiac monitoring system (CMS) that will be placed on the chest by the patient or caregiver when symptoms begin, and will record at least 5 hours of continuous ECG.
The study will include a Qualification Visit, a Treatment Period(s) , a Follow-up Visit(s) ,a Final Study Visit and if necessary an Early Termination Visit if the patient withdraws from the study after taking etripamil NS 70 mg and had a Follow-up Visit, or the patient withdraws from the study and did not take etripamil NS 70 mg.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||169 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multi-Centre, Open-Label, Safety Study of Etripamil Nasal Spray in Spontaneous Episodes of Paroxysmal Supraventricular Tachycardia The NODE-302 Trial (Extension of NODE-301)|
|Actual Study Start Date :||December 10, 2018|
|Actual Primary Completion Date :||November 13, 2020|
|Actual Study Completion Date :||November 13, 2020|
Experimental: Etripamil NS 70 mg
The dose of etripamil to be evaluated in NODE-302 is 70 mg.
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.
Other Name: MSP-2017
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.
- Time to conversion of an episode of PSVT to sinus rhythm (SR) after study drug administration. [ Time Frame: 18 months ]The efficacy analyses will be performed on the Efficacy Population. The primary efficacy variable is the time to conversion of an episode of PSVT to SR after study drug administration.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03635996