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Trial record 1 of 23 for:    NODE 301
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Efficacy and Safety of Etripamil for the Termination of Spontaneous PSVT. NODE 301 [Part 1 and Part 2 (The RAPID Study)]

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03464019
Recruitment Status : Recruiting
First Posted : March 13, 2018
Last Update Posted : September 22, 2021
Sponsor:
Collaborators:
Medpace, Inc.
IQVIA Biotech
Information provided by (Responsible Party):
Milestone Pharmaceuticals Inc.

Brief 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.


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

Detailed Description:

NODE-301 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. Each episode 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 electrocardiogram (ECG).

This is an event-driven study. The study is comprised of 2 parts: Part 1 and Part 2.

Part 1 comprised the conduct of NODE-301 up to the date of the adjudication of the 150th positively adjudicated PSVT episode (January 15th, 2020). Part 1 had the same general study design as Part 2 of the study, with the key differences being that Part 2 includes a repeat dosing option during the randomized treatment phase, as well as during an added open-label treatment phase.

Part 2 (the RAPID Study) describes the conduct of NODE-301 following the completion of Part 1. RAPID 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.

Before randomization in the RAPID study, all patients will receive a test dose of an etripamil NS dosing regimen (an initial dose of etripamil NS 70 mg followed by a second dose of etripamil NS 70 mg not earlier than 10 minutes and not later than 15 minutes after the first dose) to evaluate tolerability and to train patients on the study procedures.

The RAPID Study includes 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.

Study comprised of 4 arms:

  • 2 arms consisting of patients enrolled during Part 1 randomized 2:1 to a single dose of study drug (etripamil NS 70 mg or placebo) to treat a perceived episode of PSVT
  • 2 arms consisting of newly enrolled patients who pass a test dose regimen of etripamil NS 70 mg, randomized 1:1 to a dosing regimen of etripamil or placebo that allows patients to self-administer a second dose (not earlier than 10 minutes and not later than 15 minutes after the first dose) of study drug if symptoms are still present at 10 minutes, to treat a perceived PSVT episode.

Safety will be monitored during the treatment periods.

To ensure the safety of trial participants in RAPID, new processes or modification of listed processes may be put in place to reduce the risks associated with the COVID-19 pandemic. These potential changes include, but are not limited to, the use of tele-medicine to conduct study visit procedures, conduct of study procedures outside of the clinical site (i.e., at a patient's home) by site personnel or by trained but non-study personnel, and the distribution of investigational products by alternative secure delivery methods.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Study comprised of 4 arms:

  • 2 arms consisting of patients enrolled during Part 1 randomized 2:1 to a single dose of study drug (etripamil NS 70 mg or placebo) to treat a perceived episode of PSVT.
  • 2 arms consisting of newly enrolled patients who pass a test dose regimen of etripamil NS 70 mg, randomized 1:1 to a dosing regimen of etripamil or placebo that allows patients to self-administer a second dose (not earlier than 10 minutes and not later than 15 minutes after the first dose) of study drug if symptoms are still present at 10 minutes, to treat a perceived PSVT episode.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:

RAPID study (NODE-301 Part 2) includes an open-label treatment phase following the randomized treatment phase of the study.

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. Patients who report no tolerability issues (i.e. adverse events) related to the study drug after having finished the Randomized Treatment Period, will be entered into the Open-Label Treatment Period while the patients who have not tolerated the double-blind study drug will pass to the Final Study Visit.

Patients comprising the single dose arms will not be entered into the open-label treatment phase of the RAPID study.

Primary Purpose: Treatment
Official Title: 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.
Actual Study Start Date : June 18, 2018
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicines

Arm Intervention/treatment
Experimental: Etripamil 70 mg Single Dose
Self- administration of a single dose of 70 mg of etripamil.
Drug: Etripamil
Etripamil will be administered via the Aptar Pharma Nasal Spray Bidose System, supplied as prefilled devices packaged into child-resistant boxes with instructions for use provided in the study drug box.

Placebo Comparator: Placebo Single Dose
Self- administration of a single dose of placebo.
Drug: Placebo
Placebo will be administered via the Aptar Pharma Nasal Spray Bidose System, supplied as prefilled devices packaged into child-resistant boxes with instructions for use provided in the study drug box.

Experimental: Etripamil 70 mg with Optional Second Dose
Dosing regimen that permits a second dose of etripamil 70 mg
Drug: Etripamil
Etripamil will be administered via the Aptar Pharma Nasal Spray Bidose System, supplied as prefilled devices packaged into child-resistant boxes with instructions for use provided in the study drug box.

Placebo Comparator: Placebo with Optional Second Dose
Dosing regimen that permits a second dose of placebo.
Drug: Placebo
Placebo will be administered via the Aptar Pharma Nasal Spray Bidose System, supplied as prefilled devices packaged into child-resistant boxes with instructions for use provided in the study drug box.




Primary Outcome Measures :
  1. The time to conversion of an episode of PSVT to sinus rhythm (SR) after study drug administration. [ Time Frame: Within 30 minutes of start of study drug dosing. ]
    The primary efficacy endpoint is defined as an adjudicated termination of a positively adjudicated episode of PSVT (AV nodal reentrant tachycardia or AV reentrant tachycardia determination if possible) and conversion to sinus rhythm (SR) for at least 30 seconds within 30 minutes of start of study drug dosing.


Secondary Outcome Measures :
  1. Relief of specific symptoms (i.e., heart palpitations, rapid pulse feeling, chest pain, anxiety, shortness of breath, dizziness, and fainting) potentially associated with an episode of PSVT. [ Time Frame: 5 hours after administration of study drug ]
  2. Rating of Treatment Satisfaction Questionnaire for Medication (TSQM). [ Time Frame: 5 hours after administration of study drug ]

Other Outcome Measures:
  1. The number of positively adjudicated episodes of PSVT terminated by a vagal maneuver (VM). [ Time Frame: Up to 2 years ]
  2. The percentage of patients requiring additional medical intervention to terminate an episode of PSVT. [ Time Frame: 5 hours after administration of study drug ]
  3. The repeat of key efficacy endpoints in various subgroups of interest (e.g., concomitant medications). [ Time Frame: 5 hours after administration of study drug ]


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:

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

  1. Male or female patients at least 18 years of age;
  2. 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;
  3. History of sustained episodes of PSVT (i.e., typically lasting approximately 20 minutes or longer);
  4. Females of childbearing potential 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 and should have a negative serum pregnancy test result at the Screening Visit, a negative urine pregnancy test at the Test Dose Randomization Visit and must use an approved form of contraception between the 2 visits. Approved forms of contraception include hormonal intrauterine devices, 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:

      1. Documented hysterectomy,
      2. Documented bilateral salpingectomy or tubal ligation; or
      3. Documented bilateral oophorectomy, or
    • Premenopausal females who are sexually active with a partner who is surgically sterile (i.e.vasectomy);
    • Postmenopausal females, defined as having amenorrhea for at least 12 months without an alternative medical cause;
  5. 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
  6. Signed written informed consent.

Exclusion Criteria:

Patients who meet any of the following criteria will be excluded from participation in the study:

  1. Systolic blood pressure <90 mmHg after a 5-minute rest in sitting position at the Screening Visit or before the test dose. In patients treated with a chronic prophylactic drug for PSVT (e.g., beta-blockers, verapamil, and diltiazem), the drug may be stopped for at least the equivalent of 5 half-lives and patients may be rescreened once;
  2. History of severe symptoms of hypotension, especially syncope, during episodes of PSVT;
  3. History of atrial arrhythmia that does not involve the AV node as part of the tachycardia circuit (e.g., atrial fibrillation, atrial flutter, intra-atrial tachycardia);
  4. History of allergic reaction to verapamil;
  5. Current therapy with digoxin or any Class I or III antiarrhythmic drug, except if these drugs are stopped at least the equivalent of 5 half-lives before the Test Dose Randomization Visit;
  6. Current therapy with amiodarone, or have taken amiodarone within 30 days prior to the Test Dose Randomization Visit;
  7. Evidence of ventricular pre-excitation (e.g., delta waves, short PR interval <100 msec, Wolff-Parkinson-White syndrome) on the ECG performed at the Screening Visit or before the test dose administration;
  8. Evidence of a second- or third-degree AV block on the ECG performed at the Screening Visit or before the test dose administration;
  9. History or evidence of severe ventricular arrhythmia (e.g., torsades de pointes, ventricular fibrillation, or sustained ventricular tachycardia);
  10. Current congestive heart failure defined by the New York Heart Association Class II to IV;
  11. Stroke in the last 6 months;
  12. Evidence of hepatic dysfunction defined as alanine aminotransferase or aspartate aminotransferase >3 × the upper limit of normal (ULN) or total bilirubin >2 × ULN at the Screening Visit, unless due to Gilbert syndrome;
  13. Evidence of renal dysfunction as determined by an estimated glomerular filtration rate assessed at the Screening Visit as follows:

    1. <60 mL/min/1.73 m2 for patients <60 years of age;
    2. <40 mL/min/1.73 m2 for patients ≥60 and <70 years of age; or
    3. <35 mL/min/1.73 m2 for patients ≥70 years of age;
  14. Females who are pregnant or lactating;
  15. Evidence or history of any significant physical or psychiatric condition including drug abuse, which, in the opinion of the Investigator, could jeopardize the safety of patients, or affect their participation in the study. Additionally, the Investigator has the ability to exclude a patient if for any reason the Investigator judges the patient is not a good candidate for the study or will not be able to follow study procedures;
  16. Participation in any investigational drug or device study or the use of any investigational drug or device within 30 days of the Screening Visit; or
  17. Previously enrolled in a clinical trial for etripamil and received study drug during a perceived episode of PSVT.

Before randomization, in the RAPID study all patients will receive a test dose of etripamil NS 70 mg to evaluate tolerability and to train patients for the procedures. A failure of the test dose is considered if patients meet any of the following criteria occurring after administration of the etripamil NS 70 mg test dose:

  1. Any symptoms consistent with clinically severe hypotension such as pre-syncope, medically significant lightheadedness, syncope, nausea, or vomiting;
  2. For patients with a pre-test dose Systolic Blood Pressure above 100 mmHg:

    1. Decrease in SBP ≥40 mmHg after test dose; or
    2. Post-test dose SBP <80 mmHg;
  3. For patients with a pre-test dose SBP between 90 mmHg and 100 mmHg (inclusive):

    a) Post-test dose SBP <75 mmHg;

  4. Third-degree AV block, Mobitz II second-degree AV block, or Wenckebach with bradycardia ≤40 bpm;
  5. New, significant sinus bradycardia Heart Rate ≤40 bpm or sinus pauses (≤3 seconds), if considered by the Investigator to put the patient's safety at risk if either were to occur while not under medical supervision;
  6. Any new significant ventricular arrhythmia (premature ventricular beats and couplets [>6 premature ventricular contractions per 45 seconds ECG] are considered significant); and
  7. Atrial fibrillation or atrial flutter (event lasting longer than 30 seconds).

Patients who fail the test dose will proceed in the study as follows:

  • If the Investigator identifies a possible reversible cause of the initial test dose failure (e.g., concomitant medication such as beta-blocker), a re-challenge with a new test dose of etripamil NS 70 mg will be possible after elimination of the reversible cause (e.g., withdrawal of concomitant therapy with the appropriate washout period). Patients may be randomized if they pass the second test dose and the cause of the test dose failure is eliminated for the duration of the study; or
  • If the Investigator cannot identify a reversible cause of the initial test dose failure, or if the potential cause cannot be modified (e.g., necessary antihypertensive drug to control blood pressure), patients will not be randomized and will complete a Final Study Visit. Patients who fail the test dose will be part of the Test Dose Only Population, including all patients who received at least 1 test dose of etripamil NS 70 mg

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): NCT03464019


Contacts
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Contact: Douglas Wight, PhD +1-514-336-0444 ext 226 dwight@milestonepharma.com

Locations
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United States, Arizona
Arizona Arrhythmia Research Center Recruiting
Phoenix, Arizona, United States, 85016
Contact: Sophie Raymond    602-456-2342    sraymond@azheartrhythm.com   
Principal Investigator: Vijendra Swarup, Dr.         
United States, Arkansas
Arkansas Cardiology Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Bobbi Philips    501-227-7596 ext 1263    bphillips@acard.org   
Principal Investigator: Gerald Greer, Dr.         
United States, California
Medvin Clinical Research Recruiting
Cerritos, California, United States, 91722
Contact: Melanie Robleto    818-286-3989    Melanie@medvinresearch.com   
Principal Investigator: Ramesh Arora, Dr.         
North Coast Cardiolog Recruiting
Encinitas, California, United States, 92024
Contact: Diem Phan    858-349-8919      
Principal Investigator: Katherine Ludington, Dr.         
Los Alamitos Cardiovascular Recruiting
Los Alamitos, California, United States, 90720
Contact: Ria Ronquillo    562-430-7533 ext 223    riar@losalcardio.com   
Principal Investigator: Ramandeep Brar, Dr.         
Titan Medical Research - Oceanside Recruiting
Oceanside, California, United States, 92056
Contact: Diem Phan    858-349-8919    Diem.Phan@titanmedicalresearch.com   
Principal Investigator: Kenneth Warren Carr, Dr.         
United States, Colorado
South Denver Cardiology Associates, P.C Recruiting
Littleton, Colorado, United States, 80120
Contact: Mary Soltau    303-703-2191    msoltaue@southdenver.com   
Principal Investigator: Roger Damle, Dr.         
United States, Florida
FWD Clinical Research Recruiting
Boca Raton, Florida, United States, 33486
Contact: Esthefany Jabbour    561-484-4466      
Principal Investigator: Michael Cammarata, Dr.         
Baptist Health Ambulatory Services Recruiting
Jacksonville, Florida, United States, 32207
Contact: Doran Cassidy    904-202-7218    doran.cassidy@bmcjax.com   
Principal Investigator: Christopher Ruisi, Dr.         
United States, Georgia
Piedmont Heart Institute Recruiting
Atlanta, Georgia, United States, 30309
Contact: Bola Ajose    404-605-2875    bola.ajose@piedmont.org   
Principal Investigator: Bruce Stambler, Dr.         
IACT Health Recruiting
Columbus, Georgia, United States, 31904
Contact: Carla Burton    704-410-1116    cburton@iacthealth.com   
Principal Investigator: Alonzo Jones Sr., Dr.         
Piedmont Heart Institute- Fayetteville Recruiting
Fayetteville, Georgia, United States, 30214
Principal Investigator: Bruce Stambler, Dr.         
Piedmont Heart Institute-Fayetteville Recruiting
Fayetteville, Georgia, United States, 30309
Contact: Rhonda Manos    770-719-5920      
Principal Investigator: Bruce Stambler, Dr.         
Georgia Arrythmia Consultants&Research Institute Recruiting
Macon, Georgia, United States, 312012
Contact: Brianna Wolfe    478-755-1560    bwolfe@gacri.com   
Principal Investigator: Felix Sogade, Dr.         
United States, Idaho
St. Luke's Idaho Cardiology Associates Recruiting
Boise, Idaho, United States, 83702
Contact: Sheri LaMott    203-388-7216    lamotts@slhs.org   
Principal Investigator: Marcos Daccarett, Dr.         
United States, Indiana
Parkview Physicians Group - Cardiology Recruiting
Fort Wayne, Indiana, United States, 46845
Contact: Tracy Miller    260-266-6628    tracy.miller@parkview.com   
Principal Investigator: David Schleinkofer, Dr.         
United States, Iowa
Mercy One Iowa Heart Center Recruiting
West Des Moines, Iowa, United States, 50266
Contact: Teresa Coulson    515-633-3843    tcoulson@iowaheart.com   
Principal Investigator: Denise Sorrentino, Dr.         
United States, Louisiana
Clinical Trials of America, LLC - Monroe, LA Recruiting
Monroe, Louisiana, United States, 71291
Contact: Samantha Korn    318-737-1094    skorn@ctamerica.net   
Principal Investigator: Assad Mouhaffel, Dr.         
United States, Maryland
MedStar Health Research Institute - Chesapeake Cardiovascular Associates Recruiting
Baltimore, Maryland, United States, 21237
Contact: Cynthia Yashinski    443-777-2369    Cynthia.L.Yashinski@medstar.net   
Principal Investigator: Glenn Meininger, Dr.         
United States, Michigan
Sparrow Clinical Research Institute Recruiting
Lansing, Michigan, United States, 48912
Contact: Sandra Mitchell    517-364-5737    sandra.mitchell@sparrow.org   
Principal Investigator: John Ip, Dr.         
United States, New York
Weill Cornell Medical Center Recruiting
New York, New York, United States, 10065
Contact: Natella Fridman       jei9008@med.cornell.edu   
Principal Investigator: John Ip, Dr.         
United States, North Carolina
Sanger Heart and Vascular Institute Recruiting
Charlotte, North Carolina, United States, 28204
Contact: Ryan Bender    980-442-4900      
Principal Investigator: Joseph Thompson, Dr.         
The Presbyterian Hospital DBA Novant Health Heart and Vascular Institute Recruiting
Charlotte, North Carolina, United States, 28204
Contact: Latisha Morgan    704-264-1400    lmorgan@novanthealth.org   
Principal Investigator: Thomas Kambur, Dr.         
United States, Ohio
Hatton Institute for Research & Education, Trihealth, Inc. - cardiology Recruiting
Cincinnati, Ohio, United States, 45242
Contact: Susan Reilly    513-862-2877    susan_reilly2@trihealth.com   
Principal Investigator: Gaurang Gandhi, Dr.         
The Ohio State University (OSU) Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Adrianne Miller    614-688-8252    adrianne.miller3@osumc.edu   
Principal Investigator: Ralph Augostini, Dr.         
Rama Research LLC Recruiting
Marion, Ohio, United States, 43302
Contact: Donna Bender    740-383-7039    doka107@aol.com   
Principal Investigator: Bhola Rama, Dr.         
Heart House Research Foundation, LLC Recruiting
Springfield, Ohio, United States, 45505
Contact: Teresa Bruner    937-323-1404    hhrf.tbruner@gmail.com   
Principal Investigator: Pradeep Gujja, Dr.         
ProMedica Toledo Hospital Recruiting
Toledo, Ohio, United States, 43615
Contact: Shirley Schmidt    419-842-3025    shirley.schmidt@promedica.org   
Principal Investigator: Timothy Phelan, Dr.         
United States, South Dakota
Monument Health Clinical Research, a department of Monument Health Rapid City Hospital, Inc Recruiting
Rapid City, South Dakota, United States, 57701
Contact: Debbie Anderson    605-755-3755    danderson14@monument.health   
Principal Investigator: Saverio Barbera, Dr.         
United States, Texas
North Texas Research Associates Recruiting
Allen, Texas, United States, 75013
Principal Investigator: Saleem Akbar, Dr.         
Cardiovascular Clinic of North Texas Recruiting
Denton, Texas, United States, 76201
Contact: Asaf Usman       namsu34@gmail.com   
Principal Investigator: Salman Malik, Dr.         
AIM Trials Recruiting
Fort Worth, Texas, United States, 83702
Contact: Waseem Chughtai    214-578-4983    waseem.chughtai@aimtrials.com   
Principal Investigator: Vijay J. Jayachandran, Dr.         
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Stephen Harold    731-798-1037    harold@bcm.edu   
Principal Investigator: Wilson Lam, Dr.         
Scott & White Memorial Hospital: Baylor Scott & White Research Institute Recruiting
Temple, Texas, United States, 76508
Contact: Lizzie Kiesle    254-724-1083      
Principal Investigator: James Black, Dr.         
Bay Area Heart Recruiting
Webster, Texas, United States, 77598
Contact: Elias Moussi    832-905-5940    emoussi@bayareaheart.com   
Principal Investigator: Shah Rakesh, Dr.         
United States, Utah
IHC Health Services Inc. DBA Intermountain Medical Center Recruiting
Murray, Utah, United States, 84157-7000
Contact: Amanda Behunin    801-507-4760    Amanda.behunin@imail.org   
Principal Investigator: Jeffrey Anderson, Dr.         
Belgium
Clinique Du Sud- Luxembourg Recruiting
Arlon, Belgium, 6700
Contact: Nathalie Willame    +32 63231340      
Principal Investigator: George Mairesse, Dr.         
Imelda Hospital Recruiting
Bonheiden, Belgium, 2820
Contact: Jeroen Staessen    32 15 50 62 01      
Principal Investigator: Tom Rossenbacker, Dr.         
Universite Libre de Bruxelles (ULB) - Hopital Erasme Recruiting
Bruxelles, Belgium, 1070
Contact: Ruben Casado    32 2 555 56 81      
Principal Investigator: Ruben Casado, Dr.         
UVC Brugmann University Hospital - Centre Hospitalier Universitaire (CHU) Recruiting
Bruxelles, Belgium, 1090
Contact: Nabil Hayef    +32 2 477 25 88      
Principal Investigator: Emmanuel Catez, Dr.         
Universitair Ziekenhuis Antwerpen (UZA) Recruiting
Edegem, Belgium, 2650
Contact: Apotheek Uza    32 3 821 49 47      
Principal Investigator: Hein Heidbuchel, Dr.         
Jessa Ziekenhuis Recruiting
Hasselt, Belgium, 3500
Contact: Gregory Van Genechten    32 11 33 70 30    Gregory.VanGenechten@Jessazh.be   
Principal Investigator: Johan Vijgen, Dr.         
University Hospital (UZ) Leuven Recruiting
Leuven, Belgium, 3000
Contact: Stefanie Goris    32 16342835      
Principal Investigator: Peter Haemers, Dr.         
Regional Hospital Centre Citadelle Recruiting
Liège, Belgium, 4000
Contact: Alexa Jonas    32 4 225 67 31      
Principal Investigator: Etienne Hoffer, Dr.         
CHU Ambroise Pare Recruiting
Mons, Belgium, 7000
Contact: Pascal Godart    32 65 41 38 21    pascal.godart@hap.be   
Principal Investigator: Pascal Godart, Dr.         
CHU Mont-Godinne Recruiting
Yvoir, Belgium, 5530
Contact: Olivier Xhaet       Olivier.xhaet@uclouvain.be   
Principal Investigator: Olivier Xhaet, Dr.         
Canada, Alberta
Libin Cardiovascular Institute of Alberta - University of Calgary Recruiting
Calgary, Alberta, Canada, T2N 4Z6
Contact: Jennifer McKeage    403-210-6047      
Principal Investigator: Stephen Wilton, Dr.         
Canada, British Columbia
Vancouver Coastal Health Research Institute Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Matthew Wei    604-875-5014    matthew.wei@vch.ca   
Principal Investigator: Matthew Bennett, Dr.         
Victoria Cardiac Arrhythmia Trials, Inc. Recruiting
Victoria, British Columbia, Canada, V8T 1Z4
Contact: Caitlin Patterson    250-595-0400 ext 2      
Principal Investigator: Laurence Sterns, Dr.         
Canada, Manitoba
University of Manitoba, St Boniface General Hospital Recruiting
Winnipeg, Manitoba, Canada, R2H 2A6
Contact: Julie Muise    204-235-3501      
Principal Investigator: Clarence Khoo, Dr.         
Canada, Nova Scotia
Dalhousie University - QEII Health Sciences Centre Recruiting
Halifax, Nova Scotia, Canada, B3H 3A7
Contact: Gillian Schraefel    902-473-7733      
Principal Investigator: Amir Abdel-Wahab, Dr.         
Canada, Ontario
Cambridge Cardiac Care Centre Recruiting
Cambridge, Ontario, Canada, N1R 6V6
Contact: Beth Gebeyehu    519-624-3511    gebeyehubeth@cambridgecardiaccare.com   
Principal Investigator: Shekhar Pandey, Dr.         
Dawson Road Medical Centre Recruiting
Guelph, Ontario, Canada, N1H 1B1
Contact: Adam DeRose    226-337-1841    aderose@dawsonclinicalresearch.com   
Principal Investigator: Doug Friars, Dr.         
Partners in Advanced Cardiac Evaluation (PACE) Cardiology Clinic Recruiting
Newmarket, Ontario, Canada, M2R 3V6
Contact: Debbie Nemtean    905 895 4521    dnemtean@rogers.com   
Principal Investigator: Atul Verma, Dr.         
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: Laura Parsons    416-864-5413      
Principal Investigator: Victoria Korley, Dr.         
Canada, Quebec
The Montreal Heart Institute Recruiting
Montreal, Quebec, Canada, H1T 1C8
Contact: Marie Robitaille    514-376-3330 ext 3489      
Principal Investigator: Blandine Mondesert         
CHUM Hotel Dieu Recruiting
Montreal, Quebec, Canada, H2W 1T8
Contact: Lyne Gauhtier    905-895-4521 ext 2068      
Principal Investigator: Benoit Coutu         
Institut Universitaire de Cardiologie et de Pneumologie De Quebec Recruiting
Québec, Quebec, Canada, G1V 4G5
Contact: Nathalie Chateauvert    415-656-8711 ext 3023      
Principal Investigator: Karine Roy, Dr.         
CIUSSS de l'Estrie - CHUS Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Contact: Line Morin    819-346-1110 ext 12852      
Principal Investigator: Jean-Francois Roux, Dr.         
Hungary
CRU Hungary Kft. Recruiting
Miskolc, Hungary, 3529
Contact: Lajos Pataki         
Principal Investigator: Andrea Hornyik, Dr.         
Belvarosi Egeszseghaz Recruiting
Zalaegerszeg, Hungary, 8900
Contact: Geza Lupkovics         
Principal Investigator: Geza Lupkovics, Dr.         
Netherlands
Meander Medisch Centrum - Locatie Amersfoort Recruiting
Amersfoort, Netherlands, 3816TE
Contact: Patrick Goor    31 33 476 82 92      
Principal Investigator: Sebastiaan Velthuis, Dr.         
Ziekenhuis Rijnstate - Locatie Arnhem Recruiting
Arnhem, Netherlands, 6815 AD
Contact: Helga Halbers    31 880 056 319      
Principal Investigator: Ron Pisters, Dr.         
Tergooiziekenhuizen Blaricum Recruiting
Blaricum, Netherlands, 1261 AN
Contact: Ellen Verduyn    31 88 753 2135    everduyn@tergooi.nl   
Principal Investigator: Ward Jansen, Dr.         
Amphia Ziekenhuis - Locatie Breda Molengracht Recruiting
Breda, Netherlands, 4818 CK
Contact: Ahmed Ladak    +31 76 595 5498      
Principal Investigator: Marco Aligns, Dr.         
Reinier de Graaf Gasthuis Recruiting
Delft, Netherlands, 2625 AD
Contact: Pim Langendijk    31 15 260 3383      
Principal Investigator: Gerhard Jan Willem Bech, Dr.         
Deventer Ziekenhuis Recruiting
Deventer, Netherlands, 7416SE
Contact: Maurits Arbouw    31 570 536525      
Principal Investigator: Y.S. Tuininga, Dr.         
Ropcke-Zweers Ziekenhuis Recruiting
Hardenberg, Netherlands, 7772 SE
Contact: Marjan Beijering    31 52 3276449    m.beijering@sxb.nl   
Principal Investigator: B Van Bemmel, Dr.         
Alrijne Ziekenhuis Recruiting
Leiderdorp, Netherlands, 2353 GA
Contact: Karen Arnoldus    31 71 5828001      
Principal Investigator: Tjeerd Romer, Dr.         
Maastricht University Medical Center Recruiting
Maastricht, Netherlands, 6229 HX
Contact: Justin Luermans         
Principal Investigator: Justin Luermans, Dr.         
Bravis ziekenhuis - Locatie Roosendaal Recruiting
Roosendaal, Netherlands, 4708 AE
Contact: Angela Brans-Boeren    +31 887068313      
Principal Investigator: Reinhart Dorman, Dr.         
Poland
Nasz Lekarz Przychodnie Medyczne Recruiting
Bydgoszcz, Poland, 85-065
Contact: Wojciech Balak    48 728 400 535      
Principal Investigator: Wojciech Balak, Dr.         
NZOZ Centrum Medyczne KERmed Recruiting
Bydgoszcz, Poland, 85-231
Contact: Michal Kasprzak    48 600 181 332      
Principal Investigator: Michal Kasprzak, Dr.         
Prywatny Specjalistyczny Gabinet Internistyczny Recruiting
Libiąż, Poland, 32-590
Contact: Jacek Nowak    48 508 388 200      
Principal Investigator: Jacek Nowak, Dr.         
MEDICOME Sp. z o.o. Recruiting
Oswiecim, Poland, 32-600
Contact: Witol Zmuda    48 505 121 703      
Principal Investigator: Witol Zmuda, Dr.         
SP ZOZ Szpital Specjalistyczny w Pulawach Recruiting
Puławy, Poland, 24-100
Contact: Jacek Gniot    48 601 815 530      
Principal Investigator: Jacek Gniot, Dr.         
NZOZ Pro Cordis Sopockie Centrum Badan Kardiologicznych Recruiting
Sopot, Poland, 81-717
Contact: Pawel Miekus    48 60 1644482      
Principal Investigator: Pawel Miekus, Dr.         
SP ZOZ Szpital Specjalistyczny w Pulawach Recruiting
Toruń, Poland, 87-100
Contact: Waldemar Bebenek         
Principal Investigator: Waldemar Bebenek, Dr.         
Spain
Hospital Alvaro Cunqueiro Recruiting
Vigo, Pontevedra, Spain, 36213
Contact: Andres Iniguez Romo    34 986 825564    andres.iniguez.romo@sergas.es   
Principal Investigator: Andres Iniguez Romo, Dr.         
Hospital Universitari de Bellvitge Recruiting
Barcelona, Spain, 08907
Contact: Sonia Guerrero    34 93 260 72 29    sonia.guerrero.moreno@gmail.com   
Principal Investigator: Ignacio Anguera Camos, Dr.         
Hospital Universitario Vall d'Hebron Recruiting
Barcelona, Spain, 119-129
Contact: Nuria Rivas Gandara         
Principal Investigator: Nuria Rivas Gandara, Dr.         
Hospital Universitario La Paz Recruiting
Madrid, Spain, 28046
Contact: Pilar Gomez Salcedo    912071471      
Principal Investigator: Jose Luis Meruno Llorens, Dr.         
Hospital Universitario Central de Asturias Recruiting
Oviedo, Spain, 33011
Contact: Diego Perez Diez         
Principal Investigator: Diego Perez Diez, Dr.         
Complejo Hospitalario de Navarra Recruiting
Pamplona, Spain, 31008
Contact: Javier Martinez Basterra         
Principal Investigator: Javier Martinez Basterra, Dr.         
Hospital Clinico Universitario de Valencia Recruiting
Valencia, Spain, 46010
Contact: Veronica Guillot    +34 648071070      
Principal Investigator: Ricardo Ruiz Granell, Dr.         
Sponsors and Collaborators
Milestone Pharmaceuticals Inc.
Medpace, Inc.
IQVIA Biotech
Investigators
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Study Chair: Francis Plat, PhD Milestone Pharmaceuticals
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Responsible Party: Milestone Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT03464019    
Other Study ID Numbers: MSP-2017-1138
First Posted: March 13, 2018    Key Record Dates
Last Update Posted: September 22, 2021
Last Verified: September 2021
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.:
Paroxysmal supraventricular tachycardia
cardiac monitoring
atrioventricular nodal reentrant tachycardia
atrioventricular reciprocating tachycardia
calcium channel blocker
conversion rate
Additional relevant MeSH terms:
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Tachycardia
Tachycardia, Supraventricular
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes
Etripamil
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs