Multi-Centre, Multi-National, Open Label, Safety Study of Etripamil Nasal Spray for Patients with Paroxysmal Supraventricular Tachycardia
- Conditions
- Paroxysmal Supraventricular Tachycardiaheart rhythm disorder10007521
- Registration Number
- NL-OMON50059
- Lead Sponsor
- Milestone Pharmaceuticals
- Brief Summary
Trial never started
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 50
1) Has been diagnosed with PSVT by a medical professional and reports having at
least one previous episode of PSVT. For clarity, PSVT refers to episodic SVT
that includes the AV node as a critical part of reentrant circuit.
2) Is of at least 18 years of age
3) Signed NODE-303 written informed consent
4) Women of child-bearing potential must be willing to use at least 1 form of
contraception during the trial, and must be willing to discontinue from the
study should they become or plan to become pregnant
5) Willing and able to comply with study procedures
1) Patients with only a history of atrial arrhythmia that does not involve the
atrioventricular (AV) node as part of the tachycardia circuit (e.g., atrial
fibrillation, atrial flutter, intra-atrial tachycardia) are not eligible.
Patients with a history of these tachycardias who are also diagnosed with PSVT
are eligible.
2) History of allergic reaction to verapamil
3) Current therapy with digoxin, or any Class I or III antiarrhythmic drug.
Patients may be eligible if these drugs are stopped at least five half-lives
before the administration of etripamil NS. The only exception is amiodarone
which must be stopped 30 days before enrollment.
4) History of ventricular pre-excitation, e.g., delta waves,
Wolff-Parkinson-White syndrome.
5) History of a second- or third-degree AV block
6) Symptoms of congestive heart failure New York Heart Association Class II to
IV
7) Significant physical or psychiatric condition including alcoholism or 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
8) History of syncope due to an arrhythmic etiology at any time, or history in
last 5 years of unexplained syncope
9) Is pregnant or breastfeeding
10) Previously enrolled in a clinical trial for etripamil and received study
drug
11) History of ACS or stroke within 6 months of screening
12) Evidence of renal dysfunction as determined by an estimated glomerular
filtration rate assessed at the Screening Visit as follows:
a) < 60mL/min/1.73m2 for patients < 60 years of age
b) < 40mL/min/1.73m2 for patients >=60 and < 70 years of age
c) < 35mL/min/1.73m2 for patients >=70 years of age
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective of this study is to evaluate the safety of<br /><br>selfadministered etripamil NS. Efficacy variables will be collected as<br /><br>secondary or exploratory analyses.<br /><br><br /><br>Safety variables will include clinical adverse events (AEs), vital signs, and<br /><br>arrhythmias and conduction disorders detected on surface ECG or CMS<br /><br>recordings.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary efficacy endpoints will include:<br /><br>• Frequency of additional medical intervention to treat PSVT, as measured by<br /><br>emergency department (ED) visits, hospital admissions,<br /><br>and concomitant medication use.<br /><br>• Improvement in patient quality of life, as measured by the BIPQ, CAQ, SF-36<br /><br>questionnaire and other surveys.<br /><br>• Patient satisfaction with treatment, as measured by the Treatment<br /><br>Satisfaction Questionnaire for Medication (TSQM-9) and other<br /><br>questions.<br /><br>• Termination of PSVT episodes.<br /><br><br /><br>The exploratory endpoints will include:<br /><br>• Frequency of PSVT episodes, and use of etripamil NS for those episodes, as<br /><br>captured by the PRO.<br /><br>• Characteristics of patient PSVT episodes, as measured by the data collected<br /><br>by the CMS.</p><br>