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| ID | Type | Description | Link |
|---|---|---|---|
| CTR20221163 | Other Identifier | China CDE clinical trial registration |
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| Name | Class |
|---|---|
| Milestone Pharmaceuticals Inc. | OTHER |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Etripamil NS 70 mg with Optional Second Dose | Experimental | Dosing regimen that permits a second dose of Etripamil NS 70 mg |
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| Placebo with Optional Second Dose | Experimental | Dosing regimen that permits a second dose of placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etripamil NS 70 mg | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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:
Postmenopausal females, defined as having amenorrhea for at least 12 months without an alternative medical cause; and
Signed written informed consent.
Exclusion Criteria:
Patients who meet any of the following criteria will be excluded from participation in the study:
Before randomization in this study, all patients will receive a test dose of an etripamil NS dosing regimen.
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| Name | Affiliation | Role |
|---|---|---|
| Xiaowen Chen | Corxel Pharmaceuticals | Study Director |
| Changsheng Ma | Beijing Anzhen Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baotou Central Hospital | Baotou | China | ||||
| The First Affiliated Hospital of Baotou Medical College |
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Patients who pass the test dose of the Etripamil NS dosing regimen will be randomized in a 1:1 ratio to Etripamil NS 70mg or placebo using an Interactive Response Technology (IRT) system.
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| Placebo | Drug | 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. |
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| 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). | 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. | 1 hour after administration of study drug |
| The percentage of adverse event | Up to 2 years |
| Number of participants with arrhythmias and conduction disorders detected on surface electrocardiogram(ECG) or cardiac monitoring system (CMS) recordings. | Up to 2 years |
| 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 |
| ID | Term |
|---|---|
| D013617 | Tachycardia, Supraventricular |
| D017180 | Tachycardia, Ventricular |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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