Image

Efficacy and Safety Study of Etripamil Nasal Spray Self-Administration for the Termination of Spontaneous Episodes of Paroxysmal Supraventricular Tachycardia

Recruiting
18 years of age
Both
Phase 3

Powered by AI

Overview

To determine whether etripamil nasal spray (NS) self-administered by Chinese patients is superior to placebo at terminating episodes of PSVT in an at-home settingļ¼› To evaluate the efficacy of etripamil NS self-administered by Chinese patients compared with placebo on a range of clinical markers.

To evaluate the safety of etripamil NS self-administered by Chinese patients compared with placebo

Description

The study is a 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 PSVT in an at-home setting.

This is an event-driven study. Enrollment into the study will continue until the adjudication of the 180th positively adjudicated PSVT episode in patients treated with double-blind study drug during the Randomized Treatment Period required for the study's pivotal analysis. After the date of the adjudication of the 180th positively adjudicated PSVT episode, all randomized patients will be unblinded at this timepoint and enter into an approximately 6 months open-label period of the study.

Eligibility

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., diagnosis based on ECG , Holter
             monitoring, 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 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 an approved highly
             effective form of contraception from the time of signed informed consent until 30 days
             after the last administration of study drug.;
             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
               -  Postmenopausal females, defined as having amenorrhea for at least 12 months
                  without an alternative medical cause; and
          5. 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 (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. History of Acute Coronary Syndrome or stroke within 6 months of screening;
         12. Evidence of hepatic dysfunction ;
         13. Evidence of End-Stage Renal Disease;
         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 (e.g., illiteracy or poor understanding)
             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 or five terminal phase half-lives of the
             drug whichever is longer, prior to the Screening Visit; or
         17. Previously enrolled in a clinical trial for Etripamil and received study drug during a
             perceived episode of PSVT;
         18. An immediate family member of the participating investigator, sub-investigator, study
             coordinator, or employee of the participating investigator.
        Before randomization in this study, all patients will receive a test dose of an etripamil
        NS dosing regimen.

Study details

Tachycardia, Supraventricular, Paroxysmal Supraventricular Tachycardia

NCT05410860

Ji Xing Pharmaceuticals (Shanghai) Co., Ltd.

25 January 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.