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Safety Study of Etripamil Nasal Spray for Patients With Paroxysmal Supraventricular Tachycardia.

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ClinicalTrials.gov Identifier: NCT04072835
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : October 1, 2019
Sponsor:
Collaborator:
IQVIA Biotech
Information provided by (Responsible Party):
Milestone Pharmaceuticals Inc.

Brief Summary:
NODE-303 is a multi-center, open label (OL) study to evaluate the safety of etripamil NS in patients with Paroxysmal Supraventricular Tachycardia (PSVT). Patients will be provided with an ambulatory Cardiac Monitoring System (CMS) to help document PSVT episodes. The CMS will be self-applied by the patient, when PSVT symptoms begin. Patients will self-administer etripamil NS if vagal maneuver is ineffective. After an episode of PSVT where drug is administered, the patient will return to the investigative site for a study visit and will be given the option to continue in NODE-303 and manage subsequent episodes of PSVT with etripamil NS.

Condition or disease Intervention/treatment Phase
Paroxysmal Supraventricular Tachycardia Drug: Etripamil NS Phase 3

Detailed Description:

NODE-303 is a multi-center, open label (OL) study to evaluate the safety of etripamil NS in patients with PSVT. Patients will be provided with an ambulatory Cardiac Monitoring System (CMS) to help document PSVT episodes. The CMS will be self-applied by the patient, when PSVT symptoms begin. Patients will self-administer etripamil NS if vagal maneuver is ineffective. After an episode of PSVT where drug is administered, the patient will return to the investigative site for a study visit and will be given the option to continue in NODE-303 and manage subsequent episodes of PSVT with etripamil NS.

The study will include:

A Screening Visit during which the Investigator will verify that the patient meets the eligibility criteria of the NODE-303 study, will obtain the signed informed consent, take blood and urine for laboratory evaluations, and conduct other screening procedures. The informed consent for NODE-303 will be applicable for the initial and all subsequent PSVT episodes. A Baseline Visit during which the site will confirm eligibility, concomitant medications, train the patient on study procedures, and give the patient study drug, patient reported outcome (PRO) materials, and the CMS materials. A Treatment Period during which the patient will complete the monthly PRO survey, self-identify symptoms of PSVT, use the CMS, perform a vagal maneuver (VM), and self-administer etripamil NS if the symptoms do not resolve during or after the VM. Patients may be contacted during this period for reminders and training on what to do during a PSVT episode. Patients will also complete a per episode survey after any PSVT episode they experience. During the Treatment Period, Follow-up Visits will occur at the study site up to 14 days after each episode of PSVT which is treated with etripamil NS, and during which the Investigator will evaluate the results of the last usage of etripamil NS and decide whether the patient can continue in the study and receive a new study drug kit. A Final Study Visit that will occur when a patient discontinues or withdraws from the study, or when the overall study is completed, or the patient has completed the maximum number of doses. NODE-303 will continue until enough documented self-administrations of etripamil NS are included in the safety database to meet regulatory requirements for the etripamil NS development program. The common study end date (CSED) for the entire study will depend on the rate of accrual of the primary endpoint, unique patients with an episode. When the criteria for concluding the study have been met, the Sponsor will announce the common study end date (CSED) for the entire study and sites will be informed in advance to schedule all final patient visits prior to the CSED.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3000 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The NODE-303 Study: Multi-Centre, Multi-National,Open Label, Safety Study of Etripamil Nasal Spray for Patients With Paroxysmal Supraventricular Tachycardia.
Actual Study Start Date : September 2, 2019
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : August 31, 2021

Arm Intervention/treatment
Experimental: Etripamil NS 70mg
Patients will self-administer etripamil NS.
Drug: Etripamil NS
Patients will be provided with an ambulatory Cardiac Monitoring System (CMS) to help document PSVT episodes. The CMS will be self-applied by the patient, when PSVT symptoms begin. Patients will self-administer etripamil NS if vagal maneuver is ineffective. After an episode of PSVT where drug is administered, the patient will return to the investigative site for a study visit and will be given the option to continue in NODE-303 and manage subsequent episodes of PSVT with etripamil NS.
Other Name: MSP-2017




Primary Outcome Measures :
  1. Safety of etripamil NS 70mg for the patient-administered treatment of acute episodes of PSVT outside of the clinical setting. [ Time Frame: 10 months ]
    Measured by: Number of participants presenting Adverse Events and/or Number of participants with abnormal findings from the CMS recordings and physical examinations.


Secondary Outcome Measures :
  1. Efficacy of etripamil NS 70mg for the patient-administered treatment of acute episodes of PSVT outside of the clinical setting measured by median time to conversion post etripamil NS administration [ Time Frame: 10 Months ]
  2. Improvement in patient quality of life measured by the Treatment Satisfaction Questionnaire for Medication and/or the Patient Reported Outcomes (PRO) System . [ Time Frame: 10 Months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

A patient will be eligible for study participation if they meet all of the following criteria:

  1. Has been diagnosed with PSVT by a medical professional, and reports having at least one previous episode of PSVT. For clarity, PSVT refers to episodic Supraventricular Tachycardia (SVT) that includes the atrioventricular (AV) node as a critical part of reentrant circuit.
  2. Is at least 18 years of age;
  3. Signed NODE-303 written informed consent
  4. Women of child-bearing potential must be willing to use at least 1 form of contraception during the trial, and must be willing to discontinue from the study should they become or plan to become pregnant
  5. Willing and able to comply with study procedures

Exclusion Criteria:

A patient will be excluded from the study if they meet any of the following criteria:

  1. Patients with only a history of atrial arrhythmia that does not involve the atrioventricular (AV) node as part of the tachycardia circuit (e.g. atrial fibrillation, atrial flutter, intra-atrial tachycardia) are not eligible. Patients with a history of these tachycardias who are also diagnosed with PSVT are eligible.
  2. History of allergic reaction to verapamil
  3. Current therapy with digoxin, or any Class I or III antiarrhythmic drug. Patients may be eligible if these drugs are stopped at least five half-lives before the administration of etripamil NS. The only exception is amiodarone which must be stopped 30 days before enrollment.
  4. History of ventricular pre-excitation, e.g., delta waves, Wolff- Parkinson-White syndrome
  5. History of a second- or third-degree AV block
  6. Symptoms of congestive heart failure New York Heart Association Class II to IV
  7. Significant physical or psychiatric condition including alcoholism or drug abuse, which, in the opinion of the Investigator, could jeopardize the safety of the patient, or impede the patient's capacity to follow the study procedures
  8. History of syncope due to an arrhythmic etiology at any time, or history in last 5 years of unexplained syncope
  9. Is pregnant or breastfeeding
  10. Previously enrolled in a clinical trial for etripamil and received study drug
  11. History of Acute Coronary Syndrome (ACS) or stroke within 6 months of screening
  12. Evidence of renal dysfunction as determined by an estimated glomerular filtration rate assessed at the Screening Visit as follows:

    1. <60mL/min/1.73m2 for patients <60 years of age;
    2. <40mL/min/1.73m2 for patients ≥60 and <70 years of age c) <35mL/min/1.73m2 for patients ≥70 years of age

Information from the National Library of Medicine

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): NCT04072835


Contacts
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Contact: Valeria Nogueira 011-55-11985964226 valeria.nogueiradasilva@iqvia.com

Locations
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United States, Georgia
Site 1022 Recruiting
Cumming, Georgia, United States, 30041
United States, Utah
Site 1004 Recruiting
Riverton, Utah, United States, 84096
Sponsors and Collaborators
Milestone Pharmaceuticals Inc.
IQVIA Biotech

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Responsible Party: Milestone Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT04072835     History of Changes
Other Study ID Numbers: NODE-303
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Milestone Pharmaceuticals Inc.:
PSVT
Additional relevant MeSH terms:
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Tachycardia
Tachycardia, Supraventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes