Parkinson's sleep study halted early – what we know

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 allowed or contraindicated in the safinamide SmPC * Women who are pregnant or breast feeding * Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases.