A Prospective, Open Label, Single Arm, Clinical Study to Evaluate the Effect of Safinamide on Sleep Quality and Polysomnographic Parameters in Patients With Parkinson's Disease: the Safe Sleep Study
Patients suffering of Parkinson's Disease will be treated with 50 mg/day of Safinamide per os for 2 weeks (escalation phase). Then, safinamide will be increased up to 100 mg/day and, if tolerated, the treatment will be taken for 10 more weeks (maintenance phase). Total treatment 12 weeks.
• 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