Efficacy and Safety of Add-on Mirogabalin to NSAIDs in Lumbar Spinal Stenosis with Peripheral Neuropathic Pain: A Randomized, Open-Label Study.

"Disclosures Takuya Nikaido received lecture fees from Daiichi Sankyo Co., Ltd. Hiroshi Takatsuna, Shunsuke Tabata, and Kazuhito Shiosakai are employees of Daiichi Sankyo Co., Ltd. Taichi Nakatani is an employee of EP-CRSU Co., Ltd., and has the current affiliation: CR Data Science Department, Clinical Research Center, Real World Evidence Business Headquarters, EPS Co., Ltd. 6–29, Shin-ogawamachi, Shinjuku-ku, Tokyo 162–0814, Japan. Shin-ichi Konno received lecture fees from Daiichi Sankyo Co., Ltd., Pfizer Japan Inc., and Eisai Co., Ltd.; and scholarship donations from Stryker Japan K.K."

"Funding This study was supported by Daiichi Sankyo, Co., Ltd., Tokyo, Japan, which also provided funding for fees associated with medical writing support and the journal’s Rapid Service Fee. Daiichi Sankyo Co., Ltd. was involved in the study design, planning of the data analysis, data interpretation, and development of the manuscript, but was not involved in data management and statistical analysis. EPS Co., Ltd. was directly involved in data management and statistical analysis. The study results were not influenced by the commercial sponsor of this study (Daiichi Sankyo Co., Ltd.)."

"Trial Registration Japan Registry of Clinical Trials (jRCTs021200007)."