Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Efficacy, and Safety Study of Etripamil Nasal Spray for the Termination of Spontaneous Episodes of Paroxysmal Supraventricular Tachycardia. NODE 301 Trial.

Who is this study for? Adult patients with Paroxysmal Supraventricular Tachycardia
What treatments are being studied? Etripamil
Status: Active, not recruiting
Location: See all (149) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This is a two-part, multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of etripamil NS self-administered by patients who experience an episode of paroxysmal ventricular tachycardia (PSVT) in an at-home setting. Part 1 comprised the conduct of the NODE-301 study up to the date of the adjudication of 150th positively adjudicated PSVT episode and Part 2 comprises the conduct of the NODE-301 study after the completion of Part 1. The RAPID Study (NODE-301 - Part 2) will enroll patients enrolled during Part 1 who had not dosed with the double-blind study drug, or had not discontinued the study before the adjudication of the 150th positively adjudicated PSVT episode in Part 1, and patients enrolled into the study following the completion of Part 1. Enrollment will continue until and for approximately 6 months after the date of the adjudication of the 180th positively adjudicated PSVT episode. The study will include the following visits: A Screening Visit, A Test Dose Randomization Visit, Monthly Follow-up Visits, A Randomized Treatment Period, A Randomized Treatment Period Follow-Up Visit, An Open-Label Treatment Period, and A Final Study Visit.

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;

• Electrographically documented history of PSVT (e.g., electrocardiogram [ECG] obtained during an episode of PSVT, Holter monitoring, loop recorder, etc). If patient had a prior ablation for PSVT, patient must have documented ECG evidence of PSVT post-ablation;

• History of sustained episodes of PSVT (i.e., typically lasting approximately 20 minutes or longer);

• Females of childbearing potential who are sexually active with a male partner who is not surgically sterile (i.e., vasectomy) must agree to use a 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 serum pregnancy test result at the Screening Visit and at the Final Study Visit, a negative urine pregnancy test at the Test Dose Randomization Visit and must use a highly effective form of contraception between the visits.

• 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 tubal ligation; or

• Documented bilateral oophorectomy, or

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

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

• Signed written informed consent.

Locations
United States
Arkansas
Arkansas Cardiology
Little Rock
University of Arkansas for Medical Sciences
Little Rock
California
Medvin Clinical Research
Cerritos
North Coast Cardiolog
Encinitas
Amicis Research Center - Northridge
Northridge
Titan Medical Research - Oceanside
Oceanside
Colorado
South Denver Cardiology Associates, P.C
Littleton
Connecticut
Cardiology Associates of Fairfield County
Norwalk
Florida
FWD Clinical Research
Boca Raton
United Health Research, LLC
Miami
Georgia
Piedmont Heart Institute
Atlanta
IACT Health
Columbus
Piedmont Heart Institute- Fayetteville
Fayetteville
Piedmont Heart Institute-Fayetteville
Fayetteville
Georgia Arrythmia Consultants&Research Institute
Macon
Idaho
St. Luke's Idaho Cardiology Associates
Boise
Idaho Catalyst Clinical Research
Idaho Falls
Illinois
AMITA Health Medical Group Heart & Vascular Elk Grpve Village
Elk Grove Village
Indiana
Parkview Physicians Group - Cardiology
Fort Wayne
Louisiana
Clinical Trials of America, LLC - Monroe, LA
Monroe
Maryland
MedStar Health Research Institute - Chesapeake Cardiovascular Associates
Baltimore
Michigan
Sparrow Clinical Research Institute
Lansing
Revival Research Institute, LLC - Southgate, MI
Southgate
Missouri
Mercy Research
Saint Louis
North Carolina
Cary Research Group, LLC
Cary
Sanger Heart and Vascular Institute
Charlotte
The Presbyterian Hospital DBA Novant Health Heart and Vascular Institute
Charlotte
New Jersey
Cardiovascular Associates of the Delaware Valley - Elmer
Elmer
Cardiovascular Associates of the Delaware Valley
Haddon Heights
New York
Montefiore Medical Center
Bronx
Columbia University
New York
Weill Cornell Medical Center
New York
Ohio
The Ohio State University (OSU) Wexner Medical Center
Columbus
Rama Research LLC
Marion
ProMedica Toledo Hospital
Toledo
South Carolina
Medical University of South Carolina (MUSC)
Charleston
Prisma Health Midlands
Columbia
South Dakota
Monument Health Clinical Research, a department of Monument Health Rapid City Hospital, Inc
Rapid City
Texas
North Texas Research Associates
Allen
Cardiovascular Clinic of North Texas
Denton
Revival Research Institute, LLC
Denton
Apex Trials Group
Fort Worth
Angiocardiac Care of Texas
Houston
Scott & White Memorial Hospital: Baylor Scott & White Research Institute
Temple
Bay Area Heart
Webster
Utah
IHC Health Services Inc. DBA Intermountain Medical Center
Murray
Other Locations
Belgium
Clinique Du Sud- Luxembourg
Arlon
Imelda Hospital
Bonheiden
Universite Libre de Bruxelles (ULB) - Hopital Erasme
Bruxelles
UVC Brugmann University Hospital - Centre Hospitalier Universitaire (CHU)
Bruxelles
Universitair Ziekenhuis Antwerpen (UZA)
Edegem
Jessa Ziekenhuis
Hasselt
University Hospital (UZ) Leuven
Leuven
Regional Hospital Centre Citadelle
Liège
CHU Ambroise Pare
Mons
CHU Mont-Godinne
Yvoir
Canada
Libin Cardiovascular Institute of Alberta - University of Calgary
Calgary
Cambridge Cardiac Care Centre
Cambridge
Dawson Road Medical Centre
Guelph
Dalhousie University - QEII Health Sciences Centre
Halifax
London Health Sciences Centre
London
CHUM Hotel Dieu
Montreal
The Montreal Heart Institute
Montreal
McGill University Health Center - Research Institute
Montréal
Partners in Advanced Cardiac Evaluation (PACE) Cardiology Clinic
Newmarket
Medical Arts Health Research Group - North Vancouver
North Vancouver
Institut Universitaire de Cardiologie et de Pneumologie De Quebec
Québec
CardioVasc HR
Saint-jean-sur-richelieu
CIUSSS de l'Estrie - CHUS
Sherbrooke
CSSS du Sud de Lanaudiere - Hopital Pierre Le Gardeur
Terrebonne
St. Michael's Hospital
Toronto
Victoria Cardiac Arrhythmia Trials, Inc.
Victoria
University of Manitoba, St Boniface General Hospital
Winnipeg
France
CHRU Besancon - Hopital Jean Minjoz
Besançon
CHRU de Brest - Hopital de la Cavale Blanche
Brest
HCL Hopital Louis Pradel
Bron
Hopital Saint-Louis de La Rochelle
La Rochelle
CHU Grenoble-Alpes - Hopital Michallon
La Tronche
CHU de Lille - Institut Cœur Poumon
Lille
Centre Hospitalier de Pau
Pau
Germany
Vivantes Klinikum Neukoelln
Berlin
FAZ Dresden-Neustadt GbR
Dresden
Kardiologische Praxis
Dresden
Maerkische Gesundheitsholding GmbH - Klinikum Luedenscheid
Lüdenscheid
Peter Osypka Herzzentrum Munchen
München
Kardiologische Gemeinschaftspraxis Papenburg
Papenburg
Zentrum fuer Praevention und Rehabilitation
Siegen
Hungary
Dr Lakatos Ferenc Belgyogyaszati-Kardiologiai Maganrendelo
Bekescsaba
Del-pesti Centrumkorhaz
Budapest
Magyar Honvedseg Egeszsegugyi Kozpont
Budapest
Debreceni Egyetem Klinikai Kozpont
Debrecen
Nehezlegzes Ambulancia
Debrecen
Belvarosi Egeszseghaz
Zalaegerszeg
Netherlands
Meander Medisch Centrum - Locatie Amersfoort
Amersfoort
Ziekenhuis Rijnstate - Locatie Arnhem
Arnhem
Rode Kruis Ziekenhuis
Beverwijk
Tergooiziekenhuizen Blaricum
Blaricum
Amphia Ziekenhuis - Locatie Breda Molengracht
Breda
IJsselland ziekenhuis
Capelle Aan Den Ijssel
Reinier de Graaf Gasthuis
Delft
Jeroen Bosch Ziekenhuis
Den Bosch
Deventer Ziekenhuis
Deventer
Slingeland Ziekenhuis
Doetinchem
Ziekenhuis Gelderse Vallei
Ede
Ropcke-Zweers Ziekenhuis
Hardenberg
Treant Zorggroep
Hoogeveen
Alrijne Ziekenhuis
Leiderdorp
Maastricht University Medical Center
Maastricht
Bravis ziekenhuis - Locatie Roosendaal
Roosendaal
Franciscus Gasthuis & Vlietland - Locatie Vlietland
Schiedam
Diakonessenhuis - Locatie Utrecht
Utrecht
Poland
Centrum Medyczne KERmed
Bydgoszcz
MICS Centrum Medyczne
Bydgoszcz
American Heart of Poland S.A., IV Oddzial Kardiologii Inwazyjnej, Elektrostymulacji i Angiologii
Kędzierzyn-koźle
Gabinety Daszmed
Kraków
Prywatny Specjalistyczny Gabinet Internistyczny
Libiąż
Instytut Centrum Zdrowia Matki Polki
Łódź
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny, Uniwersytetu Medycznego w Lodzi
Łódź
MEDICOME Sp. z o.o.
Oswiecim
SP ZOZ Szpital Specjalistyczny w Pulawach
Puławy
Specjalistyczna Praktyka Lekarska
Ruda Śląska
Kliniczny Szpital Wojewódzki nr 2, Rzeszów
Rzeszów
NZOZ Pro Cordis Sopockie Centrum Badan Kardiologicznych
Sopot
Osrodek Badan Klinicznych CLINSANTE S.C.
Toruń
X Oddzial Kardiologii Inwazyjnej, Elektrofizjologii i Elektrostymulacji
Tychy
Kardiosystem
Warsaw
Spain
Generalitat Valenciana Conselleria De Sanitat
Alicante
Hospital Germans Trias i Pujol
Badalona
Hospital de la Santa Creu i Sant Pau
Barcelona
Hospital Universitari de Bellvitge
Barcelona
Hospital Universitario Vall d'Hebron
Barcelona
Hospital Universitario Reina Sofia
Córdoba
Complejo Hospitalario Universitario de Granada - Hospital Universitario Virgen de las Nieves
Granada
Martínez Hervás Cardiólogos
Granada
Hospital General Universitario Gregorio Maranon
Madrid
Hospital Universitario La Paz
Madrid
Hospital Universitario Puerta de Hierro
Majadahonda
Hospital Universitario Virgen de la Victoria
Málaga
Hospital Clinico Universitario Virgen de la Arrixaca
Murcia
Hospital Universitario Central de Asturias
Oviedo
Complejo Hospitalario de Navarra
Pamplona
Hospital Universitari Sant Joan de Reus
Reus
Hospital Clinico Universitario de Santiago
Santiago De Compostela
Hospital Universitario Virgen del Rocio
Sevilla
Hospital Universitario Virgen Macarena
Sevilla
Consorcio Hospital General Universitario de Valencia
Valencia
Hospital Clinico Universitario de Valencia
Valencia
Hospital Alvaro Cunqueiro
Vigo
Hospital Universitario Clínico Lozano Blesa
Zaragoza
Time Frame
Start Date: June 18, 2018
Estimated Completion Date: December 2022
Participants
Target number of participants: 701
Treatments
Experimental: Etripamil 70 mg Single Dose
Self- administration of a single dose of 70 mg of etripamil.
Placebo Comparator: Placebo Single Dose
Self- administration of a single dose of placebo.
Experimental: Etripamil 70 mg with Optional Second Dose
Dosing regimen that permits a second dose of etripamil 70 mg
Placebo Comparator: Placebo with Optional Second Dose
Dosing regimen that permits a second dose of placebo.
Authors
Greer Gerald, Doug Friars, Erick Lo, Ramin Mashandi, Jones Sr. Alonzo, Kenneth Ellenbogen, Aditya Verma, Atul Verma, Sean Beinart, Ralph Augostini, Salman Malik, Richard Kuk, Jose Teixeira, Alexandru Stoian, Gerald Greer, John Ip, Johan Aasbo, Dhiraj Narula, Bruce Stambler, Michael Koren, James Ip, Michael Goldstein, Suneet Mittal, Sean Mazer, Peter Noseworthy, Wilson Lam, Saleem Akbar, Javier Banchs, Jean-François Roux, Thomas Kambur, Jeffrey Anderson, David Schleinkofer, James Black, Pradeep Gujja, Sudip Datta, Bhola Rama, Katherine Ludington, Vijendra Swarup, Timothy Phelan, Sandeep Talwar, Maleah Grover-McKay, Kenneth Bilchick, Felix Sogade, Assad Mouhaffel, Roger Damle, Srivani Ambati, Ramesh Arora, Matthew Bennett, Isaac Dor, Michael Cammarata, Kenneth Warren Carr, Robert Kinn, Joseph Thompson, Andrew Yin, Robert Bernstein, Luis Ortiz Munoz, Saverio Barbera, Marcos Daccarett, Glenn Meininger, Ramandeep Brar, Stephen Winters, Alonzo Jones Sr., Kevin Rist, Sergio Cossu, Robert Gianfagna, Christopher Ruisi, Amir Abdel-Wahab, Greg Olsovsky, Pascal Godart, Sandeep Khosla, Christopher Schulze, Shekhar Pandey, Wojciech Balak, Denise Sorrentino, Emmanuel Catez, Gerhard Jan Willem Bech, Vijay J. Jayachandran, Tjeerd Romer, Jacek Gniot, Reinhart Dorman, Witol Zmuda, George Mairesse, Michal Kasprzak, Ricardo Ruiz Granell, Andrea Hornyik, Y.S. Tuininga, Marco Aligns, Jacek Nowak, Tom Rossenbacker, Gaurang Gandhi, Geza Lupkovics, Etienne Hoffer, Waldemar Bebenek, Ignacio Anguera Camos, Shah Rakesh, Diego Perez Diez, Benoit Coutu, Javier Martinez Basterra, Sebastiaan Velthuis, Pawel Miekus, Olivier Xhaet, Johan Vijgen, Clarence Khoo, Ron Pisters, Ward Jansen, Karine Roy, Jeffrey Healey, Andres Iniguez Romo, Stephen Wilton, Gearoid O'Neil, K.L. Venkatachalam, B Van Bemmel, Peter Haemers, Justin Luermans, Laurence Sterns, Victoria Korley, Hein Heidbuchel, Dhanunjaya Lakkireddy, Nathan Foster, Evan Lockwood, Blandine Mondesert, Jose Luis Meruno Llorens, Robert Goldstein, Nuria Rivas Gandara, Ruben Casado
Sponsors
Leads: Milestone Pharmaceuticals Inc.
Collaborators: Medpace, Inc., IQVIA Biotech

This content was sourced from clinicaltrials.gov

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