307
Participants
Start Date
August 1, 2019
Primary Completion Date
August 20, 2021
Study Completion Date
August 20, 2021
Safinamide
At baseline (Day 1), eligible patients will be randomised to receive safinamide (initial 50 mg titrated to 100 mg the day after the Visit 3/week 2, ideally at day 15). The investigational medicinal product (IMP) will be taken in the morning at breakfast time, in addition to the morning dose of L-dopa and other (if any) PD medications.
Placebo
At baseline (Day 1), eligible patients will be randomised to receive matching placebo, orally OD. Placebo will be added to the standard stabilized treatment as a control of the safinamide group, hence patients on placebo will have benefit from other ongoing anti-PD medication
Sir Run Run Shaw Hospital, Zhejiang University 浙江大学医学院附属邵逸夫医院, Hangzhou
Shanghai Ninth People's Hospital 上海交通大学医学院附属第九人民医院, Shanghai
Tianjin Union Medicine Center 天津市人民医院, Tianjin
The Third Xiangya Hospital of Central South University 中南大学湘雅三医院, Changsha
Renmin Hospital of Wuhan University 武汉大学人民医院, Wuhan
Sichuan Provincial People's Hospital 四川省医学科学院·四川省人民医院, Chengdu
West China Hospital, Sichuan University 四川大学华西医院, Chengdu
Beijing Friendship Hospital 首都医科大学附属北京友谊医院, Beijing
Beijing Tiantan Hospital Affiliated to Capital Medical University 首都医科大学附属北京天坛医院, Beijing
The First Bethune Hospital of Jilin University, Changchun
The First Hospital of Shanxi Medical University 山西医科大学第一医院, Taiyuan
The Second Affiliated Hospital of Zhejiang University 浙江大学医学院附属第二医院, Hangzhou
The Second Affiliated Hospital of Nanchang University 南昌大学第二附属医院, Nanchang
Guangzhou First People's Hospital 广州市第一人民医院, Guangzhou
Shanghai General Hospital 上海市第一人民医院, Shanghai
Sun Yat-sen Memorial Hospital 中山大学孙逸仙纪念医院, Guangzhou
Tongji Hospital of Tongji University 同济大学附属同济医院, Wuhan
The Third Hospital of Hebei Medical University 河北医科大学第三医院, Shijiazhuang
Chongqing Three Gorges Central Hospital 重庆三峡中心医院, Chongqing
Shanghai Ruijin Hospital 上海交通大学医学院附属瑞金医院, Shanghai
The First Affiliated Hospital of Baotou Medical University 内蒙古科技大学包头医学院第一附属医院, Baotou
Baotou City Central Hospital 包头市中心医院, Baotou
The Affiliated Hospital of Xuzhou Medical University 徐州医科大学附属医院, Xuzhou
The Affiliated Hospital Of Guiyang Medical College 贵州医科大学附属医院, Guiyang
The First Affiliated Hospital of Guangzhou Medical University 广州医科大学附属第一医院, Guangzhou
Wenzhou Medical College-The First Affiliated Hospital 温州医科大学附属第一医院, Wenzhou
Daqing Oilfield General Hospital 大庆油田总医院, Daqing
Fujian Medical University Union Hospital 福建医科大学附属协和医院, Fuzhou
Qilu Hospital of Shandong University 山东大学齐鲁医院, Jinan
Nanjing Drum Tower Hospital 南京鼓楼医院, Nanjing
The second affiliated hospital of Soochow University 苏州大学附属第二医院, Suzhou
Zambon SpA
INDUSTRY