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

Phase 4TerminatedNCT03968744

Alain Kaelin11 enrolled

Overview

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.

Adult patients affected by PD and suffering from motor fluctuations will be screened for participation. If the inclusion and exclusion criteria are met, the participant will enter in the baseline assessment phase and undergo 1 night baseline PSG and 1 week baseline actigraphy. The patient will then start the treatment 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 last for 10 weeks (maintenance phase). At week 12 (end of treatment), the questionnaires, actigraphy and PSG will be repeated. A safety follow-up visit is scheduled 4 weeks after study treatment completion. The treatment will be continued thereafter in all patients if medically indicated.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Idiopathic Parkinson's Disease (at Later Stage)

Interventions

SafinamideDRUG

Safinamide taken per Os for 12 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Neurocenter of Southern Switzerland - Ente Ospedaliero Cantonale (EOC)

Lugano, Switzerland

Outcomes

Primary Outcomes

Effect of safinamide on overall sleep quality

To measure the change in PDSS-2 (Parkinson's Disease Sleep Scale Version 2) score and the changes in sleep maintenance (=total sleep time/partial sleep time) and sleep efficiency (=total sleep time/ time in bed) scores measured by polysomnography (PSG). PDSS-2 total score ranges from 0 (no disturbance) to 60 (maximum nocturnal disturbance). Scores \> 18 are considered as relevant sleep disturbances.

Time frame: 12 weeks

Secondary Outcomes

Effect of safinamide on objective PSG sleep characterization

To determine neurophysiological sleep parameters from PSG recording

Time frame: 12 weeks

Effect of safinamide on subjective sleep quality and sleepiness

To measure the change in subjective sleep quality as measured by PDSS-2 subscores and by the electronic diary "Sleep Fit app", and in daytime sleepiness as measured by ESS (Epworth sleepiness scale) score. PDSS-2 total score ranges from 0 (no disturbance) to 60 (maximum nocturnal disturbance). Scores \> 18 are considered as relevant sleep disturbances. ESS score ranges from 0 to 24. Scores \> 10 suggest relevant daytime sleepiness.

Time frame: 12 weeks

Effect of safinamide on objective motor activity

To determine the change in motor activity as measured by a specific objective measure of bradykinesia (FitTest) in the electronic diary "Sleep Fit app".

Time frame: 12 weeks

Effect of safinamide on subjective motor activity

To measure the change in motor activity as measured by UPDRS (Unified Parkinson's Disease Rating Scale). Higher UPDRS score indicates more severe impairment of non-motor and motor activities.

Time frame: 12 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.