Long-term effects of safinamide adjunct therapy on levodopa-induced dyskinesia in Parkinson's disease: post-hoc analysis of a Japanese phase III study.

"Declarations Conflict of interestNH received personal fees from Meiji Seika Pharma Co., Ltd. during the conduct of the submitted work; grants from Ono Pharmaceutical Co., Ltd., FP Corp., Eisai Co., Ltd., and Nihon Mediphysics Co., Ltd.; personal fees from Sumitomo Dainippon Pharma Co., Ltd., Otsuka Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., Kyowa Hakko-Kirin Co., Ltd., Nippon Boehringer Ingelheim Co., Ltd., FP Corp., Eisai Co., Ltd., Kissei Pharmaceutical Co., Ltd., Nihon Medi-physics Co., Ltd., Novartis Pharma K.K., Biogen Idec Japan Ltd., AbbVie GK, Boston Scientific Japan K.K., Sanofi K.K., Alexion Pharmaceuticals, Inc., Mylan N.V., Daiichi Sankyo Co., Ltd., Hisamitsu Pharmaceuticals Co., Inc., and Kao Corp.; and reports donations to the department, endowed research departments and joint collaborative research departments from Sumitomo Dainippon Pharma Co., Ltd., Otsuka Pharmaceutical, Co., Ltd., Takeda Pharmaceutical Co., Ltd., Kyowa Hakko-Kirin Co., Ltd., Nippon Boehringer Ingelheim Co., Ltd., Eisai Co., Ltd., GSK K.K., Kissei Pharmaceutical Co. Ltd., Novartis Pharma K.K., Nihon Medi-physics Co., Ltd., Biogen Idec Japan Ltd., AbbVie GK, Medtronic, Inc., Boston Scientific Japan K.K., Ono Pharmaceutical Co., Ltd., Hydrogen Health Medical Labo Co., ABIST Co., Ltd., Daiwa Co., Ltd., Bayer Yakuhin Ltd., Nihon Pharmaceutical Co., Ltd., Asahi Kasei Medical Co., Ltd., MiZ Co., Ltd., Mitsubishi Tanabe Pharma Corporation, Daiichi Sankyo Co. Ltd., and OHARA Pharmaceutical Co., Ltd. outside the submitted work. TK, TI, and IS are employees of Eisai Co., Ltd. MN received lecture fees from Eisai Co., Ltd., Kyowa Hakko Kirin Co., Ltd., Takeda Pharmaceutical Co., Ltd., and consulting fees from Kissei Pharmaceutical Co. Ltd., and Hisamitsu Pharmaceutical Co., Ltd. YT received Honoraria from Eisai Co., Ltd., during the conduct of the submitted work, and Sumitomo Dainippon Pharma Co., Ltd., Takeda Pharmaceutical Co., Ltd., Novartis Pharma K.K., AbbVie GK., Otsuka Pharmaceutical Co., Ltd., Ono Pharmaceutical Co., Ltd., Kyowa Kirin Co., Ltd., Sunwels Co., Ltd., Eisai Co., Ltd. and Nipro Co., Ltd., outside the submitted work. Ethical approvalThe study protocol was approved by an ethics committee at each study site. The study conduct adhered to the ethical principles of the Declaration of Helsinki, Good Clinical Practice Guidelines, and local laws and regulations. Informed consentInformed consent was obtained from all the participants in the study. Conflict of interest NH received personal fees from Meiji Seika Pharma Co., Ltd. during the conduct of the submitted work; grants from Ono Pharmaceutical Co., Ltd., FP Corp., Eisai Co., Ltd., and Nihon Mediphysics Co., Ltd.; personal fees from Sumitomo Dainippon Pharma Co., Ltd., Otsuka Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., Kyowa Hakko-Kirin Co., Ltd., Nippon Boehringer Ingelheim Co., Ltd., FP Corp., Eisai Co., Ltd., Kissei Pharmaceutical Co., Ltd., Nihon Medi-physics Co., Ltd., Novartis Pharma K.K., Biogen Idec Japan Ltd., AbbVie GK, Boston Scientific Japan K.K., Sanofi K.K., Alexion Pharmaceuticals, Inc., Mylan N.V., Daiichi Sankyo Co., Ltd., Hisamitsu Pharmaceuticals Co., Inc., and Kao Corp.; and reports donations to the department, endowed research departments and joint collaborative research departments from Sumitomo Dainippon Pharma Co., Ltd., Otsuka Pharmaceutical, Co., Ltd., Takeda Pharmaceutical Co., Ltd., Kyowa Hakko-Kirin Co., Ltd., Nippon Boehringer Ingelheim Co., Ltd., Eisai Co., Ltd., GSK K.K., Kissei Pharmaceutical Co. Ltd., Novartis Pharma K.K., Nihon Medi-physics Co., Ltd., Biogen Idec Japan Ltd., AbbVie GK, Medtronic, Inc., Boston Scientific Japan K.K., Ono Pharmaceutical Co., Ltd., Hydrogen Health Medical Labo Co., ABIST Co., Ltd., Daiwa Co., Ltd., Bayer Yakuhin Ltd., Nihon Pharmaceutical Co., Ltd., Asahi Kasei Medical Co., Ltd., MiZ Co., Ltd., Mitsubishi Tanabe Pharma Corporation, Daiichi Sankyo Co. Ltd., and OHARA Pharmaceutical Co., Ltd. outside the submitted work. TK, TI, and IS are employees of Eisai Co., Ltd. MN received lecture fees from Eisai Co., Ltd., Kyowa Hakko Kirin Co., Ltd., Takeda Pharmaceutical Co., Ltd., and consulting fees from Kissei Pharmaceutical Co. Ltd., and Hisamitsu Pharmaceutical Co., Ltd. YT received Honoraria from Eisai Co., Ltd., during the conduct of the submitted work, and Sumitomo Dainippon Pharma Co., Ltd., Takeda Pharmaceutical Co., Ltd., Novartis Pharma K.K., AbbVie GK., Otsuka Pharmaceutical Co., Ltd., Ono Pharmaceutical Co., Ltd., Kyowa Kirin Co., Ltd., Sunwels Co., Ltd., Eisai Co., Ltd. and Nipro Co., Ltd., outside the submitted work."

"Funding This research was funded by Eisai Co., Ltd. The phase III clinical trial was sponsored by Meiji Seika Pharma Co., Ltd."

"The study protocol was approved by an ethics committee at each study site, and all patients provided informed consent before study initiation. The study conduct adhered to the ethical principles of the Declaration of Helsinki, Good Clinical Practice Guidelines, and local laws and regulations. The study was registered in the Japan Pharmaceutical Information Center under the identifier JapicCTI-153057."