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)

Status: Completed
Location: See all (34) locations...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Phase 3
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Patients who meet all of the following criteria will be eligible to participate in the study:

• Male or female patients at least 18 years of age;

• Signed the NODE-302 written informed consent;

• Previously randomized in the NODE-301 study:

• Received the study drug to treat symptoms the patient believed were consistent with an episode of PSVT during the NODE-301 study, irrespective of the study drug efficacy; OR

• Did not experience an episode of PSVT or did not use the study drug at the time of the NODE-301 study completion;

• Willing and able to comply with all aspects of the study;

• Females of childbearing potential who are sexually active must agree to use an approved highly effective form of contraception from the time of signed informed consent until 30 days after the last administration of study drug. Females of childbearing potential should have a negative urine pregnancy test result at the Qualification Visit and at the Follow-up Visit(s), and must use an approved form of contraception between the 2 visits. Approved forms of contraception include hormonal intrauterine devices and hormonal contraceptives (oral birth control pills, Depo Provera®, patch, or other injectables) together with supplementary double barrier methods, such as condoms or diaphragms with spermicidal gel or foam;

• The following categories define females who are NOT considered to be of childbearing potential:

• Premenopausal females with 1 of the following:

• Documented hysterectomy,

• Documented bilateral salpingectomy, or

• Documented bilateral oophorectomy, or

• Postmenopausal females, defined as having amenorrhea for at least 12 months without an alternative medical cause; and

• Male patients, except those who are surgically sterile, must use an approved highly effective form of contraception during the 3 days after study drug administration.

Locations
United States
Arkansas
Arkansas Cardiology
Little Rock
Arizona
Arizona Arrhythmia Research Center
Phoenix
California
Los Alamitos Cardiovascular
Los Alamitos
Colorado
South Denver Cardiology Associates, P.C
Littleton
Florida
Baptist Health Ambulatory Services
Jacksonville
Mayo Clinic - Jacksonville
Jacksonville
Edgewater Medical Research
New Smyrna Beach
Georgia
Piedmont Heart Institute
Atlanta
Columbus Regional Research Institute
Columbus
Georgia Arrythmia Consultants&Research Institute
Macon
Iowa
Iowa Heart Center
West Des Moines
Maryland
MedStar Health Research Institute
Baltimore
Minnesota
Mayo Clinic
Rochester
North Carolina
The Presbyterian Hospital DBA Novant Health Heart and Vascular Institute
Charlotte
New Jersey
Atlantic Health System - Morristown Medical Center
Morristown
New York
Trinity Medical WNY, PC
Buffalo
Weill Cornell Medical Center
New York
Ohio
Heart House Research Foundation, LLC
Springfield
South Dakota
Black Hills Cardiovascular Research
Rapid City
Texas
Baylor College of Medicine
Houston
Baylor Scott and White Research Institute - Round Rock
Round Rock
Utah
IHC Health Services Inc. DBA Intermountain Medical Center
Murray
Other Locations
Canada
Libin Cardiovascular Institute of Alberta - University of Calgary
Calgary
Cambridge Cardiac Care Centre
Cambridge
Royal Alexandra Hospital
Edmonton
Dawson Road Medical Centre
Guelph
Hamilton Health Sciences
Hamilton
Montreal Heart Institute - Institut de Cardiologie de Montréal
Montréal
Partners in Advanced Cardiac Evaluation (PACE) Cardiology Clinic
Newmarket
CIUSSS de l'Estrie - CHUS ; Hôpital Fleurimont
Sherbrooke
St. Michael's Hospital
Toronto
Vancouver General Hospital - Research Institute ; Gordon and Leslie Diamond Health Centre
Vancouver
Victoria Cardiac Arrhythmia Trials, Inc.
Victoria
University of Manitoba, St Boniface General Hospital
Winnipeg
Time Frame
Start Date: December 10, 2018
Completion Date: November 13, 2020
Participants
Target number of participants: 169
Treatments
Experimental: Etripamil NS 70 mg
The dose of etripamil to be evaluated in NODE-302 is 70 mg.
Authors
Greer Gerald, Doug Friars, Jones Sr. Alonzo, Kenneth Ellenbogen, Aditya Verma, Atul Verma, Sean Beinart, Ralph Augostini, Richard Kuk, Jose Teixeira, Alexandru Stoian, Eric Lo, John Ip, Johan Aasbo, Ramin Manshadi, Bruce Stambler, Michael Koren, James Ip, Michael Goldstein, Suneet Mittal, Sean Mazer, Wilson Lam, Javier Banchs, Jean-François Roux, Thomas Kambur, Jeffrey Anderson, James Black, Pradeep Gujja, Sudip Datta, Vijendra Swarup, Sandeep Talwar, Maleah Grover-McKay, Kenneth Bilchick, Felix Sogade, Roger Damle, Srivani Ambati, Matthew Bennett, Isaac Dor, Robert Kinn, Robert Bernstein, Luis Ortiz Munoz, Marcos Daccarett, Glenn Meininger, Ramandeep Brar, Kevin Rist, Sergio Cossu, Robert Gianfagna, Christopher Ruisi, Winters Stephen, Amir Abdel-Wahab, Sandeep Khosla, Christopher Schulze, Shekhar Pandey, Denise Sorrentino, Vijay J. Jayachandran, Gaurang Gandhi, Clarence Khoo, Jeffrey Healey, Stephen Wilton, Gearoid O'Neil, K.L. Venkatachalam, Laurence Sterns, Victoria Korley, Dhanunjaya Lakkireddy, Nathan Foster, Evan Lockwood, Blandine Mondesert, Robert Goldstein
Sponsors
Leads: Milestone Pharmaceuticals Inc.
Collaborators: Medpace, Inc.

This content was sourced from clinicaltrials.gov

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