Clinical trial NCT03968744: Effect of Safinamide on Sleep Quality in Patients With Parkinson's Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Idiopathic Parkinson's Disease (at Later Stage)
Lead sponsor: Ente Ospedaliero Cantonale, Bellinzona
Sponsor class: OTHER
Collaborators: name: Clinical Trial Unit Ente Ospedaliero Cantonale
First posted: 2019-05-30
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Effect of safinamide on overall sleep quality
timeFrame: 12 weeks
Secondary outcomes:
measure: Effect of safinamide on objective PSG sleep characterization
timeFrame: 12 weeks
measure: Effect of safinamide on subjective sleep quality and sleepiness
timeFrame: 12 weeks
measure: Effect of safinamide on objective motor activity
timeFrame: 12 weeks
measure: Effect of safinamide on subjective motor activity
timeFrame: 12 weeks
measure: Effect of safinamide on objective sleep parameters and motor symptoms
timeFrame: 12 weeks
measure: Effect of safinamide on non-motor symptoms
timeFrame: 12 weeks
measure: Effect of safinamide on quality of life
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Lugano
country: Switzerland
facility: Neurocenter of Southern Switzerland - Ente Ospedaliero Cantonale (EOC)
Study officials:
References: