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Trial record 1 of 1 for:    NOde302
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Safety Study of Intranasal Etripamil for the Termination of Spontaneous Episodes of PSVT. NODE-302

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: NCT03635996
Recruitment Status : Recruiting
First Posted : August 17, 2018
Last Update Posted : September 29, 2020
Sponsor:
Collaborator:
Medpace, Inc.
Information provided by (Responsible Party):
Milestone Pharmaceuticals Inc.

Tracking Information
First Submitted Date  ICMJE August 14, 2018
First Posted Date  ICMJE August 17, 2018
Last Update Posted Date September 29, 2020
Actual Study Start Date  ICMJE December 10, 2018
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 14, 2018)
Time to conversion of an episode of PSVT to sinus rhythm (SR) after study drug administration. [ Time Frame: 18 months ]
The efficacy analyses will be performed on the Efficacy Population. The primary efficacy variable is the time to conversion of an episode of PSVT to SR after study drug administration.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Study of Intranasal Etripamil for the Termination of Spontaneous Episodes of PSVT. NODE-302
Official Title  ICMJE 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)
Brief 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).
Detailed Description

The NODE-302 study is an extension of the NODE-301 efficacy study. It is a multi-centre, open label study designed to evaluate the safety of etripamil NS 70 mg when self-administered by patients for spontaneous episodes of PSVT in an outpatient setting. All patients randomized in the NODE-301 study and who meet the inclusion and exclusion criteria of the NODE-302 study are eligible for the NODE-302 study.

After each episode of PSVT, patients will have the option to continue in the NODE-302 study and manage subsequent episodes of PSVT with etripamil NS 70 mg if they do not meet any withdrawal criteria.

Each episode of PSVT 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 ECG.

The study will include a Qualification Visit, a Treatment Period(s) , a Follow-up Visit(s) ,a Final Study Visit and if necessary an Early Termination Visit if the patient withdraws from the study after taking etripamil NS 70 mg and had a Follow-up Visit, or the patient withdraws from the study and did not take etripamil NS 70 mg.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Paroxysmal Supraventricular Tachycardia
Intervention  ICMJE Drug: Etripamil NS 70 mg
All patients will receive a total of 200 micro-liters of etripamil NS 70 mg via the Aptar Pharma Nasal Spray Bidose System each time they self-administer study drug. The devices will be prefilled and packaged into child-resistant boxes.Instructions for its use will be provided in the study drug box.
Other Name: MSP-2017
Study Arms  ICMJE Experimental: Etripamil NS 70 mg
The dose of etripamil to be evaluated in NODE-302 is 70 mg.
Intervention: Drug: Etripamil NS 70 mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 14, 2018)
125
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2022
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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. Signed the NODE-302 written informed consent;
  3. 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;
  4. Willing and able to comply with all aspects of the study;
  5. 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:

      1. Documented hysterectomy,
      2. Documented bilateral salpingectomy, or
      3. Documented bilateral oophorectomy, or
    • Postmenopausal females, defined as having amenorrhea for at least 12 months without an alternative medical cause; and
  6. 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.

Exclusion Criteria

Patients who meet any of the following criteria will be excluded from participation in the study, including but not limited to:

  1. Evidence of new severe arrhythmia discovered since the NODE-301 Test Dose Randomization Visit, including those reported on the Cardiac Monitoring System (CMS) report of the outpatient PSVT event treated with the study drug in the NODE 301 study:

    d. Third-degree AV block, Mobitz II second-degree AV block, or Wenckebach with bradycardia ≤40 bpm; e. Significant symptomatic sinus bradycardia heart rate (HR) ≤40 bpm or sinus pauses (≥3 seconds); f. Any significant ventricular arrhythmia (premature ventricular beats and couplets [>6 premature ventricular contractions per 45 seconds electrocardiogram (ECG)] are considered significant); or g. Atrial fibrillation (event lasting longer than 30 seconds);

  2. Any drug-related or procedure-related serious adverse event during the NODE-301 study;
  3. Any severe adverse event (AE) in the NODE-301 study that was severe enough to preclude administration of etripamil NS 70 mg in the NODE-302 study;
  4. Any new drug prescribed after the end of the patient's participation in the NODE-301 study that could lower blood pressure or decrease AV node conduction;
  5. Systolic blood pressure <90 mmHg after a 5-minute rest in sitting position at the NODE-302 Qualification Visit;
  6. Any symptoms consistent with clinically severe hypotension such as presyncope, medically significant lightheadedness, syncope, nausea, or vomiting;
  7. New therapy with digoxin, amiodarone, or any Class I or III antiarrhythmic drug added after the end of the patient's participation in the NODE-301 study;
  8. New evidence of ventricular pre-excitation (e.g., delta waves, short PR interval, Wolff Parkinson-White syndrome) on the ECG since randomization in the NODE-301 study;
  9. New symptoms of congestive heart failure defined by the New York Heart Association Class II to IV since randomization in the NODE-301 study;
  10. New stroke since randomization in the NODE-301 study;
  11. New evidence of a significant physical or psychiatric condition including 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 since randomization in the NODE-301 study;
  12. New syncope since randomization in the NODE-301 study, especially if observed during the monitoring of the event treated in the NODE-301 study;
  13. New evidence of hepatic dysfunction defined as alanine aminotransferase or aspartate aminotransferase >3 × the upper limit of normal (ULN) or total bilirubin >2 × ULN, unless due to Gilbert syndrome observed at the NODE-302 Qualification Visit;
  14. New evidence of renal dysfunction as determined by an estimated glomerular filtration rate assessed at the NODE-302 Qualification 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;
  15. Participation in any investigational drug or device study or the use of any investigational drug or device since the Final Study Visit in the NODE-301 study.

Withdrawal Criteria

Patient participation in this clinical study may be discontinued for any of the following reasons:

  • The patient withdraws consent or requests discontinuation from the study for any reason;
  • The patient took the study drug in both the NODE-301 and the NODE-302 studies for symptoms not associated with an episode of PSVT;
  • Occurrence of any medical condition, AE, or circumstance that exposes the patient to substantial risk and/or does not allow the patient to adhere to the requirements of the protocol;
  • Requirement of a prohibited concomitant medication and/or change in the use of chronic therapies, such as concomitant beta-blockers, calcium channel blockers, and medications that can lower blood pressure;
  • Patient failure to comply with protocol requirements or study-related procedures;
  • Termination of the study by Milestone or a regulatory authority; or
  • The patient self-administered a total of 11 doses of etripamil Nasal Spray 70 mg in the NODE-302 study.

Patients who withdraw from the study after taking etripamil Nasal Spray 70 mg and had a Follow-up Visit will be required to undergo an Early Termination Visit.

Patients who withdraw from the study and did not take etripamil Nasal Spray 70 mg will be required to undergo an Early Termination Visit.

Patients who withdraw after taking the study drug but did not have a Follow-up Visit will be required to undergo a Final Study Visit.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Douglas Wight, MSc +1-514-336-0444 ext 226 dwight@milestonepharma.com
Contact: Francis Plat, MD +1-514-336-0444 ext 225 fplat@milestonepharma.com
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03635996
Other Study ID Numbers  ICMJE MSP-2017-1158
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Milestone Pharmaceuticals Inc.
Study Sponsor  ICMJE Milestone Pharmaceuticals Inc.
Collaborators  ICMJE Medpace, Inc.
Investigators  ICMJE Not Provided
PRS Account Milestone Pharmaceuticals Inc.
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP