Effect of Safinamide on Sleep Quality in Patients With Parkinson's Disease

Inclusion Criteria: * Age ≥ 18 years old * Fluctuating idiopathic PD patients according to UK Brain bank Criteria * Hoehn and Year II to IV under treatment * Sleep disturbance with a Pittsburgh Sleep Quality Index (PSQI) \> 5 * Treatment with L-DOPA, alone or with other dopaminergic drugs, at a stable dose since at least 28 days prior to inclusion * Treatment with all substances potentially acting on sleep and mood must be constant since at least 28 days prior to inclusion * Written informed consent * Willingness and ability to participate in the trial Exclusion Criteria: * Off label use of safinamide * Early PD or absence of PD fluctuations * Concomitant treatment with other MAO-B inhibitors (wash-out period: at least 14 days) * Atypical Parkinsonism * Severe known sleep-related breathing disorders with any specific treatment or severe known sleep-related breathing disorders (apnoea-hypopnea index score \>30/h) with or without a specific treatment * Dementia (MoCA \< 26) * Severe depression (BDI-II ≥ 29) * Other severe psychiatric symptoms such as active psychosis or major hallucinations * Any previous or concomitant severe medical conditions or clinical laboratory abnormality which, in the clinical judgement of the Investigators, does not allow patients' participation into the study * Moderate or severe hepatic impairment, any type of retinopathy and/or any pathology that is deemed to be a contraindication according to safinamide's SmPC * Any concomitant treatment not al…