A Study to Evaluate the Efficacy and Safety of Safinamide, as add-on Therapy, in Idiopathic Chinese Parkinson's Disease (PD) Patients With Motor Fluctuations Treated With Stable Doses of Levodopa

Summary

This is a Phase III, multicentre, randomised, double-blind, placebo-controlled study to evaluate the effects of 100 mg safinamide, administered orally once daily (OD), in Chinese Parkinson's disease (PD) patients, experiencing motor fluctuations while on stable doses of Levodopa (L-dopa) (alone or in combination with other anti-Parkinson drugs). Eligible patients are required to meet the United Kingdom PD Society Brain Bank Clinical Diagnostic Criteria. The study involves a placebo group. 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. A total of 306 patients will be randomised into this study (153 in the safinamide and 153 in the placebo groups).

Timeline

Start

2019-08-01

Primary completion

2021-08-20

Completion

2021-08-20

Publications

• Dei Cas A, Micheli MM, Aldigeri R, Gardini S, Ferrari-Pellegrini F, Perini M, Messa G, Antonini M, Spigoni V, Cinquegrani G, Vazzana A, Moretti V, Caffarra P, Bonadonna RC. Long-acting exenatide does not prevent cognitive decline in mild cognitive impairment: a proof-of-concept clinical trial. J Endocrinol Invest. 2024 Sep;47(9):2339-2349. doi: 10.1007/s40618-024-02320-7. Epub 2024 Apr 2.
• Cattaneo C, Kulisevsky J. The Effects of Safinamide in Chinese and Non-Chinese Patients with Parkinson's Disease. Adv Ther. 2024 Feb;41(2):638-648. doi: 10.1007/s12325-023-02736-2. Epub 2023 Dec 9.
• Wei Q, Tan Y, Xu P, Tao E, Lu Z, Pan X, Wang B, Liu C, Dong X, Tian Y, Sun X, Cattaneo C, Chen S, Shang H; XINDI Study Investigators Group. The XINDI Study: A Randomized Phase III Clinical Trial Evaluating the Efficacy and Safety of Safinamide as Add-On Therapy to Levodopa in Chinese Patients with Parkinson's Disease with Motor Fluctuations. CNS Drugs. 2022 Nov;36(11):1217-1227. doi: 10.1007/s40263-022-00958-6. Epub 2022 Nov 8.

Drugs

Indications