Efficacy and Safety of Intranasal MSP-2017 (Etripamil) for the Conversion of PSVT to Sinus Rhythm
NODE-1
Multi-Center, Placebo-Controlled, Dose-Ranging Phase 2 Electrophysiological Study of Intranasal Administration of MSP-2017 for the Conversion of Induced Paroxysmal Supraventricular Tachycardia (PSVT) to Sinus Rhythm
1 other identifier
interventional
199
2 countries
30
Brief Summary
The primary objective of this study is to demonstrate the superiority of at least 1 dose of intranasal (IN) MSP-2017 (Etripamil) over placebo in terminating PSVT induced in an electrophysiology (EP) laboratory.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2015
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 18, 2014
CompletedFirst Posted
Study publicly available on registry
November 20, 2014
CompletedStudy Start
First participant enrolled
March 27, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedResults Posted
Study results publicly available
December 30, 2020
CompletedDecember 30, 2020
December 1, 2020
1.7 years
November 18, 2014
August 12, 2020
December 4, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
The Percentage of Subjects Successfully Converted From PSVT to Sinus Rhythm Within 15 Minutes of Study Drug Administration
The primary efficacy endpoint was the rate of successful PSVT conversion to sinus rhythm lasting at least 30 seconds within 15 minutes of study drug administration after a minimum of 5 minutes in sustained PSVT.
Within 15 minutes of study drug administration
Study Arms (2)
Etripamil
EXPERIMENTAL1 dose of Etripamil via 4 intranasal applications at time 0 (140 mg, 105 mg, 70 mg, or 35 mg)
Placebo
PLACEBO COMPARATOR1 dose of placebo via 4 intranasal applications at time 0
Interventions
Eligibility Criteria
You may qualify if:
- Male or female, aged 18 years and older at Screening
- Has a history of PSVT
- Is scheduled for an electrophysiology study and catheter ablation
- Has provided written informed consent
- Agrees to use a medically accepted form of contraception or abstinence to prevent pregnancy. Males must agree to use an acceptable form of contraception or abstinence from the time of study drug administration through the Follow-up Visit. Females must agree to use an acceptable form of contraception or abstinence from Screening until 30 days following study drug administration. Post-menopausal female subjects must be amenorrheic for ≥ 12 months prior to Screening or ≥ 6 weeks post-surgical bilateral oophorectomy (with or without hysterectomy) prior to Screening, if they do not wish to use an acceptable form of contraception or abstinence. Acceptable forms of contraception include: A condom and an intrauterine device; A condom and hormonal contraception; A condom and a diaphragm; Sterilization of the subject or the subject's partner(s) (sterilization procedure must have been performed 3 or more months prior); Hysterectomy of the subject or the subject's partner(s)
- If a female of childbearing potential: Has a negative serum pregnancy test result at Screening (Screening must occur ≥7 days prior to randomization \[ie, on or before Day -7\]) and at the Treatment Visit (pre-PSVT induction); Has had a menstrual period within 28 days of the Treatment Visit.
You may not qualify if:
- Has a history of serious allergic reaction to verapamil (especially when administered intravenously) including rash, itching or swelling (especially of the face, tongue, or throat), severe dizziness, or trouble breathing
- Is currently participating in another drug or device study, or has received an investigational drug or device within 30 days of Screening
- Has evidence of clinically significant cardiovascular, endocrine, gastrointestinal, hematologic, hepatic, immunologic, neurologic, oncologic, pulmonary, psychiatric, or renal disease or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of study results
- Is a female who is breast feeding, pregnant, or planning to become pregnant during the study period
- Has evidence of any clinically significant acute or chronic condition of the nasal cavity (e.g., rhinitis or deviated septum) which could interfere with IN administration of the study drug in either or both nasal cavities
- Has any of the following at screening or at the Treatment Visit: Systolic blood pressure \<100 mmHg, Diastolic blood pressure \<50 mmHg
- Has evidence of hepatic impairment, defined as: Alanine aminotransferase or aspartate aminotransferase levels that are greater than or equal to 3× upper limit of normal (ULN) or Bilirubin levels that are greater than or equal to 2× ULN, unless due to Gilbert's syndrome
- Has evidence of renal impairment, defined as an estimated glomerular filtration rate \<30 mL/min (Modification of Diet in Renal Disease method)
- Has taken digoxin, verapamil, diltiazem, or any Class I, II (e.g., beta blockers), or III antiarrhythmic drug less than the equivalent of 5 half-lives of this drug prior to the Treatment Visit
- Has taken amiodarone within 30 days of the Treatment Visit
- Has taken drugs of abuse which, in the opinion of the Investigator, would impact the validity of study results
- Has had myocardial infarction, percutaneous coronary intervention, cerebrovascular accident, transient ischemic attack, unstable angina, or acute decompensation of heart failure within 6 months of Screening
- Has a history or evidence of second- or third-degree atrioventricular block
- Has an implanted device (e.g., pacemaker, or implantable cardioverter defibrillator) that precludes study participation in the opinion of the Investigator and Study Medical Monitor
- Has a history or evidence of preexcitation syndrome (e.g., Wolff-Parkinson- White syndrome, short PR, etc.)
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Milestone Pharmaceuticals Inc.lead
- Medpace, Inc.collaborator
Study Sites (30)
Arizona Heart Rhythm Center
Phoenix, Arizona, 85013, United States
Mayo Clinic Arizona
Phoenix, Arizona, 85054, United States
Mercy General Hospital
Sacramento, California, 95819, United States
South Denver Cardiology Associates
Littleton, Colorado, 80120, United States
Medstar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Memorial Hospital Jacksonville
Jacksonville, Florida, 32216, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224, United States
Northside Hospital
St. Petersburg, Florida, 33709, United States
University of South Florida Health South Tampa Center
Tampa, Florida, 33606, United States
Piedmont Atlanta Hospital
Atlanta, Georgia, 30309, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
Iowa Heart Center
West Des Moines, Iowa, 50266, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
MedStar Health Research Institute
Baltimore, Maryland, 21237, United States
Mayo Clinic
Rochester, Minnesota, 55902, United States
Aultman Hospital Cardiology Clinical Trials
Canton, Ohio, 44708, United States
University of Cincinnati Medical Center Division of Cardiovascular Diseases
Cincinnati, Ohio, 45267, United States
ProMedica Toledo Hospital
Toledo, Ohio, 43606, United States
Great Lakes Medical Research, LLC
Willoughby, Ohio, 44094, United States
Black Hills Cardiovascular Research
Rapid City, South Dakota, 57701, United States
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705, United States
Baylor St. Luke's Hospital
Houston, Texas, 77030, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
University of Virginia Medical Center
Charlottesville, Virginia, 22908, United States
Centra Stroobants Cardiovascular Center
Lynchburg, Virginia, 24501, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507, United States
Sunnybrook Health Sciences Center
Toronto, Ontario, M4N 3M5, Canada
St. Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
The Montreal Heart Institute
Montreal, Quebec, H1T 1C8, Canada
CHUM Hotel Dieu
Montreal, Quebec, H2W 1T8, Canada
Related Publications (1)
Stambler BS, Dorian P, Sager PT, Wight D, Douville P, Potvin D, Shamszad P, Haberman RJ, Kuk RS, Lakkireddy DR, Teixeira JM, Bilchick KC, Damle RS, Bernstein RC, Lam WW, O'Neill G, Noseworthy PA, Venkatachalam KL, Coutu B, Mondesert B, Plat F. Etripamil Nasal Spray for Rapid Conversion of Supraventricular Tachycardia to Sinus Rhythm. J Am Coll Cardiol. 2018 Jul 31;72(5):489-497. doi: 10.1016/j.jacc.2018.04.082.
PMID: 30049309DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Francis Plat _MD_Chief Medical Officer
- Organization
- Milestone Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Francis Plat
Chief Medical Officer
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- If, during the double-blind study, PSVT could not be induced, the mechanism of PSVT was neither atrioventricular (AV) reentrant tachycardia (AVRT) nor AV nodal reentrant tachycardia (AVNRT), or it was not possible to sustain an episode of PSVT for 5 minutes in a subject who previously provided written informed consent for substudy participation, the subject was eligible to participate in the optional open-label substudy.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2014
First Posted
November 20, 2014
Study Start
March 27, 2015
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
December 30, 2020
Results First Posted
December 30, 2020
Record last verified: 2020-12
Data Sharing
- IPD Sharing
- Will not share