Efficacy and Safety Study of Etripamil Nasal Spray Self-Administration for the Termination of Spontaneous Episodes of Paroxysmal Supraventricular Tachycardia
- Conditions
- Paroxysmal Supraventricular TachycardiaTachycardia, Supraventricular
- Interventions
- Drug: Placebo
- Registration Number
- NCT05410860
- Lead Sponsor
- Corxel Pharmaceuticals
- Brief Summary
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 setting； 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
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 500
Patients who meet all of the following criteria will be eligible to participate in the study:
-
Male or female patients at least 18 years of age;
-
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;
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History of sustained episodes of PSVT (i.e., typically lasting 20 minutes or longer);
-
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:
- Documented hysterectomy;
- Documented bilateral salpingectomy or tubal ligation; or
- Documented bilateral oophorectomy; or
-
Postmenopausal females, defined as having amenorrhea for at least 12 months without an alternative medical cause; and
-
-
Signed written informed consent.
Patients who meet any of the following criteria will be excluded from participation in the study:
- 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;
- History of severe symptoms of hypotension, especially syncope, during episodes of PSVT;
- 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);
- History of allergic reaction to verapamil;
- 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;
- Current chronic therapy with oral amiodarone, or have taken oral amiodarone within 30 days prior to the Test Dose Randomization Visit;
- 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;
- Evidence of a second- or third-degree AV block on the ECG performed at the Screening Visit or before the test dose administration;
- History or evidence of severe ventricular arrhythmia (e.g., torsades de pointes, ventricular fibrillation, or ventricular tachycardia);
- Current congestive heart failure defined by the New York Heart Association Class II to IV;
- History of Acute Coronary Syndrome or stroke within 6 months of screening;
- Evidence of hepatic dysfunction ;
- Evidence of End-Stage Renal Disease;
- Females who are pregnant or lactating;
- 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;
- 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
- Previously enrolled in a clinical trial for Etripamil and received study drug during a perceived episode of PSVT;
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo with Optional Second Dose Placebo Dosing regimen that permits a second dose of placebo Etripamil NS 70 mg with Optional Second Dose Etripamil NS 70 mg Dosing regimen that permits a second dose of Etripamil NS 70 mg
- Primary Outcome Measures
Name Time Method Time to an adjudicated termination of a positively adjudicated episode of PSVT and conversion to sinus rhythm (SR) for at least 30 seconds within 30 minutes of start of study drug dosing Within 30 minutes of start of study drug dosing. The primary efficacy endpoint is defined as an adjudicated termination of a positively adjudicated episode of PSVT (AV nodal reentrant tachycardia or AV reentrant tachycardia determination if possible) and conversion to sinus rhythm (SR) for at least 30 seconds within 30 minutes of start of study drug dosing.
- Secondary Outcome Measures
Name Time Method Time to conversion in patients with the option of repeat administration 1 hour after administration of study drug The percentage of patients requiring additional medical intervention in emergency department to terminate an episode of PSVT Up to 2 years Time to conversion at time points of 5, 10, 15, 45, and 60 minutes 1 hour after administration of study drug Number of participants with arrhythmias and conduction disorders detected on surface electrocardiogram（ECG） or cardiac monitoring system (CMS) recordings. Up to 2 years Rating of Treatment Satisfaction Questionnaire for Medication (TSQM). 1 hour after administration of study drug Treatment satisfaction will be analyzed by comparing the Treatment Satisfaction Questionnaire for Medication 9(TSQM-9) score for satisfaction in the 2 treatment groups. The TSQM-9 is composed of 9 questions with responses on a scale of 1 (extremely dissatisfied) to 7 (extremely satisfied). A higher score indicated greater satisfaction with medication.
Number of participants with relief of specific symptoms (i.e., heart palpitations, rapid pulse feeling, chest pain, anxiety, shortness of breath, dizziness, and fainting) 1 hour after administration of study drug The percentage of adverse event Up to 2 years
Trial Locations
- Locations (53)
Peking Union Medical College Hospital
🇨🇳Beijing, China
The First Affiliated Hospital of Baotou Medical College
🇨🇳Baotou, China
Affiliated Zhongshan Hospital of Dalian University
🇨🇳Dalian, China
Huai'an First People's Hospital
🇨🇳Huai'an, China
Shandong Province Qianfoshan Hospital
🇨🇳Jinan, China
The First Affiliated Hospital of Henan Science and Technology University
🇨🇳Luoyang, China
Nanyang Second General Hospital
🇨🇳Nanyang, China
Baotou Central Hospital
🇨🇳Baotou, China
Xiangya Hospital, Central South University
🇨🇳Changsha, China
Nanfang Hospital of Southern Medical University
🇨🇳Guangzhou, China
The Third Xiangya Hospital of Central South University
🇨🇳Changsha, China
People's Hospital of Deyang City
🇨🇳Deyang, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
🇨🇳Hangzhou, China
The First People's Hospital of Hangzhou Linping District
🇨🇳Hangzhou, China
The First Affiliated Hospital of Jinzhou Medical University
🇨🇳Jinzhou, China
Lanzhou University Second Hospital
🇨🇳Lanzhou, China
Jiangsu Taizhou People's Hospital
🇨🇳Taizhou, China
Tianjin Medical University General Hospital
🇨🇳Tianjin, China
The First Affiliated Hospital of Bengbu Medical College
🇨🇳Bengbu, China
The First Hospital of Jilin University
🇨🇳Ch'ang-ch'un, China
The First Affiliated Hospital of Chengdu Medical College
🇨🇳Chengdu, China
The First Affiliated Hospital of Fujian Medical University
🇨🇳Fuzhou, China
Zhejiang Provincial People's Hospital
🇨🇳Hangzhou, China
Lishui Municipal Central Hospital
🇨🇳Lishui, China
Guizhou Provincial People's Hospital
🇨🇳Guiyang, China
Xingtai Third Hospital
🇨🇳Xingtai, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
🇨🇳Wuhan, China
ZiBo Central Hospital
🇨🇳Zibo, China
Huizhou Municipal Central Hospital
🇨🇳Huizhou, China
Mianyang Central Hospital
🇨🇳Mianyang, China
The Nanchang Third Hospital
🇨🇳Nanchang, China
The Second Affiliated Hospital of Nanchang University
🇨🇳Nanchang, China
Guangxi Zhuang Autonomous Region People's Hospital
🇨🇳Nanning, China
The second affiliated Hospital of Guangxi Medical University
🇨🇳Nanning, China
Ningbo First Hospital
🇨🇳Ningbo, China
Shangrao People's Hospital
🇨🇳Shangrao, China
Binhai Hospital (Tianjin Fifth Central Hospital)
🇨🇳Tianjin, China
CR and WISCO General Hospital
🇨🇳Wuhan, China
The Fourth Affiliated Hospital Zhejiang University School of Medicine
🇨🇳Yiwu, China
Beijing Anzhen Hospital; Capital Medical University
🇨🇳Beijing, China
Beijing Tongren Hospital, Capital Medical University
🇨🇳Beijing, China
Beijing Hospital
🇨🇳Beijing, China
Changzhou No.2 People's Hospital
🇨🇳Changzhou, China
Huainan First People's Hospital
🇨🇳Huainan, China
Jinan Central Hospital
🇨🇳Jinan, China
Ruijin Hospital of Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai, China
Shanghai Pudong New Area People's Hospital
🇨🇳Shanghai, China
Shanghai Tongren Hospital
🇨🇳Shanghai, China
Shanxi Cardiovascular Hospital
🇨🇳Taiyuan, China
Chui Yang Liu Hospital Affiliated to Tsinghua University
🇨🇳Beijing, China
The Central Hospital of China Aerospace Corporation
🇨🇳Beijing, China
Jiangsu Province Hospital
🇨🇳Nanjing, China
Nanjing Drum Tower Hospital
🇨🇳Nanjing, China