Abstract
Excessive daytime sleepiness (EDS) is common in Parkinson’s disease (PD) and may respond to dopaminergic therapies. The aim of this open-label trial was to assess the efficacy and safety of selegiline as a treatment for EDS in PD patients. In this multi-center study, 141 PD subjects were enrolled between December 2019 and October 2020, and 121 patients completed the 8-week study. Selegiline was administered at 5 mg/day in the first week and was increased to 10 mg per day during the following weeks. EDS was evaluated using the Epworth Sleepiness Scale (ESS) at baseline, week 3, and week 8. Changes in motor complications, sleep quality, and quality of life were also assessed in patients with PD. As primary outcomes, ESS scores decreased significantly in PD patients who received selegiline for 8 weeks (P < 0.001). As secondary outcomes, the scores of Parkinson's disease sleep scale (PDSS) and Parkinson’s disease quality of life questionnaire 39 (PDQ-39) also improved after the treatment. The severity of motor fluctuation improved (P=0.037), while the percentage of patients with dyskinesia and the severity of dyskinesia did not increase significantly compared with baseline. Participants treated with selegiline showed an improvement in EDS and good tolerance of the drug. This study demonstrated the efficacy of selegiline for the treatment of daytime sleepiness in PD patients.Trial registration: clinicaltrials, NCT04870372. Registered 5 May 2021 - Retrospectively registered, https://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid=S0009J06&selectaction=Edit&uid=U00026CP&ts=2&cx=ruz8uy.
Correction to: A phase 2, open-label, multi-center study to evaluate the efficacy and safety of 99mTc-TRODAT-1 SPECT to detect Parkinson’s disease