BRIEF RESEARCH REPORT article
Front. Neurol.
Sec. Movement Disorders
Volume 16 - 2025 | doi: 10.3389/fneur.2025.1591664
Safinamide as an Adjunct to Levodopa Monotherapy in Asian Patients with Parkinson's Disease Experiencing Early Wearing-off: A Pooled Analysis of the J-SILVER and KEEP studies
Provisionally accepted
Noriko Nishikawa1*
Do-Young Kwon2
Yuki Kogo3
Taku Hatano1
Jin Whan Cho4
Chizuru Kobayashi5Hiroyuki Shiiba3JiEun Kim6
Takayuki Ishida3
Jong Sam Baik7*
Nobutaka Hattori1- 1Department of Neurology, School of Medicine, Juntendo University, Bunkyō, Tōkyō, Japan
- 2Department of Neurology, College of Medicine, Korea University, Seoul, Seoul, Republic of Korea
- 3Medical Headquarters, Eisai Co. Ltd., Tokyo, Japan
- 4Department of Neurology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
- 5Deep Human Biology Learning, Eisai Co. Ltd., Tokyo, Japan
- 6Department of Medical, Eisai Korea Inc., Seoul, Republic of Korea
- 7Department of Neurology, Inje University Ilsan Paik Hospital, Goyang, Gyeonggi, Republic of Korea
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Background: Limited trials are evaluating the efficacy of monoamine oxidase B inhibitors as an adjunct to levodopa monotherapy for early wearing-off in Parkinson's disease (PD). We evaluated the efficacy and safety of safinamide in patients with fluctuating PD treated with levodopa monotherapy.Methods: This pooled analysis used data from the J-SILVER and KEEP studies and targeted patients with PD experiencing wearing-off who received safinamide as adjunct to levodopa monotherapy. Efficacy endpoints were mean changes in 39-item Parkinson's Disease Questionnaire (PDQ-39), Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts III and IV, and daily OFF time at 18 weeks of treatment.Results: Of 54 patients (J-SILVER, N=24; KEEP, N=30), 41 completed the studies. Although not statistically significant, the change in PDQ-39 Summary Index exceeded the minimal clinical important difference (mean [SD]: -2.2 [7.5], P=0.094) at Week 18. Significant improvements in MDS-UPDRS Parts III and IV scores and daily OFF time were observed at Week 18 from baseline (mean [
Keywords: Parkinson's disease, MAO-B inhibitor, safinamide, sodium channel blocker, early wearing-off, Elderly
Received: 11 Mar 2025; Accepted: 23 Apr 2025.
Copyright: © 2025 Nishikawa, Kwon, Kogo, Hatano, Cho, Kobayashi, Shiiba, Kim, Ishida, Baik and Hattori. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Noriko Nishikawa, Department of Neurology, School of Medicine, Juntendo University, Bunkyō, 113-8421, Tōkyō, Japan
Jong Sam Baik, Department of Neurology, Inje University Ilsan Paik Hospital, Goyang, Gyeonggi, Republic of Korea
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.