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;The RAPID Study (NODE-301 Part 2)
- Conditions
- heart rhythm disorderParoxysmal Supraventricular Tachycardia10007521
- Registration Number
- NL-OMON52096
- Lead Sponsor
- Milestone Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 21
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 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:
a. Documented hysterectomy;
b. Documented bilateral salpingectomy or tubal ligation; or
c. Documented bilateral oophorectomy; or
• 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 a highly
effective form of contraception during the 3 days after any study drug
administration; and
6. Signed written informed consent.
Patients who meet any of the following criteria will be excluded from
participation in the study:
1. Systolic blood pressure (SBP) <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, patients may be rescreened once, and chronic use of the drug cannot
be restarted after randomization.
2. History of severe symptoms of hypotension, especially syncope, during
episodes of PSVT;
3. 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);
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 chronic therapy with oral amiodarone, or have taken oral 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 ventricular tachycardia);
10. Current congestive heart failure defined by the New York Heart Association
Class II to IV;
11. Stroke in the last within 6 months of screening;
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 End-Stage Renal Disease as determined by an estimated
glomerular filtration rate assessed at the Screening Visit of <15mL/min/1.73m2
or requiring hemodialysis;
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary efficacy endpoint is defined as time to an adjudicated termination<br /><br>of a positively adjudicated episode of PSVT and conversion to SR for at least<br /><br>30 seconds within 30 minutes of start of study drug dosing.</p><br>
- Secondary Outcome Measures
Name Time Method