Table 1.
Institutions involved in the study.
Institution | City | Role and activity | Work package |
---|---|---|---|
Peking University Third Hospital | Beijing | Coordinating center | Convene expert committee, formulate the protocol and create the case report form (CRF) with statistics unit. |
Submit application to ethical committees. | |||
Train the protocol and outcomes measure. | |||
Present and disseminate the results with the permission of the sponsor. | |||
Enroll and follow-up the subjects. | |||
The Second Hospital of Hebei Medical University | Shijiazhuang | Enrolling center | Participate in the seminar on protocol formulation and provide suggestions. |
Henan Provinclal People’s Hosipital | Zhengzhou | Complete the training of the protocol and outcomes measure. | |
The First Affiliated Hosipital, Sun Yat-Sen University | Guangzhou | ||
Enroll and follow-up at least four subjects. | |||
Guangdong Province Traditional Chinese Medical Hospital | Guangzhou | ||
The Second Affiliated Hospital, Zhejiang University School of Medicine | Hangzhou | ||
West China Hospital of Sichuan University | Chengdu | ||
The First Affiliated Hospital of Xi’an Jiaotong University | Xi’an | ||
Fujian Medical University Union Hospital | Fuzhou | ||
The First Affiliated Hospital of Harbin Medical University | Harbin | ||
Renmin Hospital of Wuhan University | Wuhan | ||
/ | / | Independent Data Monitoring Committee | Safety monitoring, efficacy monitoring, operational quality control, and suggestions for adjustment of trial design. |
Conduct an interim analysis and assess the risks and benefits for the subjects. | |||
Make a key recommendation whether the trial continues. | |||
Wuhan Zhizhi Medical and Pharmaceutical Technology Co., Ltd. | Wuhan | Statistics unit | Participate in the design of the protocol and statistical plans. |
Establishment and management of Electronic Data Capture System and central randomization system. | |||
Blind codes. | |||
Statistical analysis. | |||
Beijing Qi-Huang Technology Co., Ltd. | Beijing | Contract Research Organization | Monitor the trial. |
Foshan Kaichuan Pharma Co., Ltd., Shanghai Pharma Rare Disease Medicine Co., Ltd | Foshan Shanghai | sponsor and funders | Provide funding. |
Provide HLSJ, riluzole tablets and simulants. | |||
Present and disseminate the results. | |||
Medkey Med-Tech Development Co., Ltd. | Shanghai | Site Management Organization | Assist investigators in completing the screening, enrolling, and follow-up of the subjects. |