Efficacy and Safety Study of Etripamil Nasal Spray Self-Administration for the Termination of Spontaneous Episodes of Paroxysmal Supraventricular Tachycardia
NCT ID: NCT05410860
Last Updated: 2024-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
500 participants
INTERVENTIONAL
2022-06-30
2024-12-10
Brief Summary
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To evaluate the safety of etripamil NS self-administered by Chinese patients compared with placebo
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Etripamil NS 70 mg with Optional Second Dose
Dosing regimen that permits a second dose of Etripamil NS 70 mg
Etripamil NS 70 mg
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 with Optional Second Dose
Dosing regimen that permits a second dose of placebo
Placebo
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.
Interventions
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Etripamil NS 70 mg
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
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
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Milestone Pharmaceuticals Inc.
OTHER
Corxel Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Xiaowen Chen
Role: STUDY_DIRECTOR
Corxel Pharmaceuticals
Changsheng Ma
Role: PRINCIPAL_INVESTIGATOR
Beijing Anzhen Hospital
Locations
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Baotou Central Hospital
Baotou, , China
The First Affiliated Hospital of Baotou Medical College
Baotou, , China
Beijing Anzhen Hospital; Capital Medical University
Beijing, , 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
Countries
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Other Identifiers
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CTR20221163
Identifier Type: OTHER
Identifier Source: secondary_id
JX02002
Identifier Type: -
Identifier Source: org_study_id