Long-Term Safety and Efficacy of Mirogabalin for Central Neuropathic Pain: A Multinational, Phase 3, 52-Week, Open-Label Study in Asia

The authors thank the staff of all participating institutions for their support of this research, and the patients themselves.

Funding

This research was supported by Daiichi Sankyo Co., Ltd., Tokyo, Japan, which also funded the rapid service fees for publication of this manuscript.

Medical Writing and Editorial Assistance

The authors thank Mary Richardson, MSc, of Edanz (www.edanz.com), for providing medical writing support, which was funded by Daiichi Sankyo Co., Ltd., in accordance with Good Publication Practice (GPP3) guidelines (http://www.ismpp.org/gpp3).

Authorship

All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.

Author Contributions

All authors contributed to the conceptualization of the study, review and editing of the manuscript, and visualization of the published work. All authors accessed the data, and Masanori Kuroha, Yoshihiro Kakehi, and Kunika Kikumori verified the data. Takahiro Ushida, Yoichi Katayama, Yoichi Hiasa, Makoto Nishihara, Masanori Kuroha, Yoshihiro Kakehi, and Kunika Kikumori contributed to the methodology. Kunika Kikumori performed the formal analysis. Fumihiro Tajima, Shinsuke Katoh, Hirotaka Tanaka, Takeshi Maeda, and Kazunari Furusawa conducted the clinical investigation. Fumihiro Tajima, Shinsuke Katoh, Hirotaka Tanaka, Takeshi Maeda, and Kazunari Furusawa contributed to provision of study materials/resources and data curation. Takahiro Ushida, Masanori Kuroha, Yoshihiro Kakehi, and Kunika Kikumori helped write the original draft. Takahiro Ushida, Yoichi Katayama, Yoichi Hiasa, Makoto Nishihara, Masanori Kuroha, and Yoshihiro Kakehi supervised the study. Masanori Kuroha, Yoshihiro Kakehi, and Kunika Kikumori contributed to project administration and funding acquisition. All authors had full access to all the data in the study and had final responsibility for the decision to submit for publication.

Prior Presentation

Data from the double-blind placebo-controlled phase of this study were previously published in Neurology, 2023;100(11):e1193–206.

Disclosures

Takahiro Ushida received lecture fees and scholarship fees from Daiichi Sankyo Co., Ltd., and lecture fees outside the submitted work from Asahi Kasei Pharma Corp., AbbVie G.K., Viatris Inc., Eisai Co., Ltd., Suzuken Co., Ltd., Shionogi and Co., Ltd., Taisho Pharmaceutical Co., Ltd., Chugai Pharmaceutical Co., Ltd., Teijin Pharma Ltd., Nipro Corp., Eli Lilly Japan K.K., Nippon Zoki Pharmaceutical Co., Ltd., Hisamitsu Pharmaceutical Co., Inc., Pfizer Japan Inc., Boston Scientific Japan K.K., Mundipharma K.K., Medical QOL Co., Ltd., Janssen Pharmaceutical K.K., Tsumura and Co., Taisho Toyama Pharmaceutical Co., Ltd., and Mitsubishi Tanabe Pharma Corp. Makoto Nishihara received lecture fees from Daiichi Sankyo Co., Ltd., and lecture fees outside the submitted work from Shionogi and Co., Ltd., Eli Lilly Japan K.K., Hisamitsu Pharmaceutical Co., Inc., Pfizer Japan Inc., Mochida Pharmaceutical Co., Ltd., and Mitsubishi Tanabe Pharma Corp. The institution to which Takahiro Ushida and Makoto Nishihara are affiliated (Aichi Medical University) received research funding outside the submitted work from Nippon Zoki Pharmaceutical Co., Ltd., Kyoto University, Pascal Universe Co., Ltd., and BonBon Inc., and scholarship fees outside the submitted work from Astellas Pharma Inc., AbbVie G.K., Osuga Clinic, Zenki Clinic, Clinics of Youteikai, Kowa Medical Society, Otsuka Pharmaceutical Co., Ltd., Tsumura and Co., Shionogi and Co., Ltd., Daiichi Sankyo Co., Ltd., Taisho Pharmaceutical Co., Ltd., Taisho Toyama Pharmaceutical Co., Ltd., Chugai Pharmaceutical Co., Ltd., Nipro Corp., Eli Lilly Japan K.K., Pfizer Japan Inc., Boston Scientific Japan K.K., and Mochida Pharmaceutical Co., Ltd. Yoichi Hiasa received consulting fees from Daiichi Sankyo Co., Ltd., and research funding outside the submitted work from Ono Pharmaceutical Co., Ltd., AbbVie G.K., Takeda Pharmaceutical Co., Ltd., Otsuka Pharmaceutical Co., Ltd., and Novartis Pharma K.K., and lecture fees outside the submitted work from MSD K.K., AbbVie G.K., and Gilead Sciences, Inc. Yoichi Katayama, Fumihiro Tajima, Shinsuke Katoh, Hirotaka Tanaka, Takeshi Maeda, and Kazunari Furusawa have no conflicts of interest to declare. Masanori Kuroha, Yoshihiro Kakehi, and Kunika Kikumori are employees of Daiichi Sankyo Co., Ltd., which funded this study.

Compliance with Ethics Guidelines

The study protocol, protocol amendments, informed consent forms, and information sheets were approved by the relevant Independent Ethics Committees or Institutional Review Boards at each study center (see Table S1 in the Supplementary Material for a list of participating institutions). This study was conducted in compliance with the protocol and ethical principles that have their origin in the Declaration of Helsinki, the International Council for Harmonisation Good Clinical Practice guidelines, and the Japanese Ministry of Health, Labour and Welfare. All patients provided written informed consent prior to participating in the study. This trial was registered in ClinicalTrials.gov under the identifier NCT03901352.

Data Availability

The datasets generated during and/or analyzed during the current study are not publicly available, but are available from the corresponding author on reasonable request at https://vivli.org/ourmember/daiichi-sankyo/.

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