Efficacy and Safety Study of Etripamil Nasal Spray Self-Administration for the Termination of Spontaneous Episodes of Paroxysmal Supraventricular Tachycardia
Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Etripamil Nasal Spray Self-Administration for the Termination of Spontaneous Episodes of Paroxysmal Supraventricular Tachycardia in Chinese Patients
2 other identifiers
interventional
500
1 country
53
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2022
53 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 5, 2022
CompletedFirst Posted
Study publicly available on registry
June 8, 2022
CompletedStudy Start
First participant enrolled
June 30, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 2, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 10, 2024
CompletedDecember 24, 2024
September 1, 2024
2.1 years
June 5, 2022
December 20, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
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.
Within 30 minutes of start of study drug dosing.
Secondary Outcomes (7)
Time to conversion at time points of 5, 10, 15, 45, and 60 minutes
1 hour after administration of study drug
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
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
Rating of Treatment Satisfaction Questionnaire for Medication (TSQM).
1 hour after administration of study drug
- +2 more secondary outcomes
Study Arms (2)
Etripamil NS 70 mg with Optional Second Dose
EXPERIMENTALDosing regimen that permits a second dose of Etripamil NS 70 mg
Placebo with Optional Second Dose
EXPERIMENTALDosing regimen that permits a second dose of placebo
Interventions
Etripamil NS 70 mg will be administered via the Aptar Pharma Nasal Spray Bidose System, supplied as prefilled devices packaged into child-resistant boxes with instructions for use provided in the study drug box.
Placebo will be administered via the Aptar Pharma Nasal Spray Bidose System, supplied as prefilled devices packaged into child-resistant boxes with instructions for use provided in the study drug box.
Eligibility Criteria
You may qualify if:
- 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;
- 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.
You may not qualify if:
- 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;
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Corxel Pharmaceuticalslead
- Milestone Pharmaceuticals Inc.collaborator
Study Sites (53)
Baotou Central Hospital
Baotou, China
The First Affiliated Hospital of Baotou Medical College
Baotou, China
Beijing Anzhen Hospital; Capital Medical University
Beijing, 100032, China
Beijing Hospital
Beijing, China
Beijing Tongren Hospital, Capital Medical University
Beijing, China
Chui Yang Liu Hospital Affiliated to Tsinghua University
Beijing, China
Peking Union Medical College Hospital
Beijing, China
The Central Hospital of China Aerospace Corporation
Beijing, China
The First Affiliated Hospital of Bengbu Medical College
Bengbu, China
The Third Xiangya Hospital of Central South University
Changsha, China
Xiangya Hospital, Central South University
Changsha, China
Changzhou No.2 People's Hospital
Changzhou, China
The First Affiliated Hospital of Chengdu Medical College
Chengdu, China
The First Hospital of Jilin University
Ch’ang-ch’un, China
Affiliated Zhongshan Hospital of Dalian University
Dalian, China
People's Hospital of Deyang City
Deyang, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, China
Nanfang Hospital of Southern Medical University
Guangzhou, China
Guizhou Provincial People's Hospital
Guiyang, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, China
The First People's Hospital of Hangzhou Linping District
Hangzhou, China
Zhejiang Provincial People's Hospital
Hangzhou, China
Huai'an First People's Hospital
Huai'an, China
Huainan First People's Hospital
Huainan, China
Huizhou Municipal Central Hospital
Huizhou, China
Jinan Central Hospital
Jinan, China
Shandong Province Qianfoshan Hospital
Jinan, China
The First Affiliated Hospital of Jinzhou Medical University
Jinzhou, China
Lanzhou University Second Hospital
Lanzhou, China
Lishui Municipal Central Hospital
Lishui, China
The First Affiliated Hospital of Henan Science and Technology University
Luoyang, China
Mianyang Central Hospital
Mianyang, China
The Nanchang Third Hospital
Nanchang, China
The Second Affiliated Hospital of Nanchang University
Nanchang, China
Jiangsu Province Hospital
Nanjing, China
Nanjing Drum Tower Hospital
Nanjing, China
Guangxi Zhuang Autonomous Region People's Hospital
Nanning, China
The second affiliated Hospital of Guangxi Medical University
Nanning, China
Nanyang Second General Hospital
Nanyang, China
Ningbo First Hospital
Ningbo, 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
Shangrao People's Hospital
Shangrao, China
Shanxi Cardiovascular Hospital
Taiyuan, China
Jiangsu Taizhou People's Hospital
Taizhou, China
Binhai Hospital (Tianjin Fifth Central Hospital)
Tianjin, China
Tianjin Medical University General Hospital
Tianjin, China
CR and WISCO General Hospital
Wuhan, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, China
Xingtai Third Hospital
Xingtai, China
The Fourth Affiliated Hospital Zhejiang University School of Medicine
Yiwu, China
ZiBo Central Hospital
Zibo, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Xiaowen Chen
Corxel Pharmaceuticals
- PRINCIPAL INVESTIGATOR
Changsheng Ma
Beijing Anzhen Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2022
First Posted
June 8, 2022
Study Start
June 30, 2022
Primary Completion
August 2, 2024
Study Completion
December 10, 2024
Last Updated
December 24, 2024
Record last verified: 2024-09