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

NCT ID: NCT03968744

Last Updated: 2025-07-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-18
• Study Completion Date: 2026-04-30

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.

Conditions

Idiopathic Parkinson's Disease (at Later Stage)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Safinamide

PO treatment: 2 weeks of treatment at dose 50 mg/day followed by 10 weeks at 100 mg/day

Group Type: EXPERIMENTAL

Safinamide

Intervention Type: DRUG

Safinamide taken per Os for 12 weeks

Interventions

Safinamide

Safinamide taken per Os for 12 weeks

Intervention Type: DRUG

Other Intervention Names

Xadago

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinical Trial Unit Ente Ospedaliero Cantonale

OTHER

Sponsor Role: collaborator

Alain Kaelin

OTHER

Sponsor Role: lead

Responsible Party

Alain Kaelin

Director of Neurocenter of Southern Switzerland

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Neurocenter of Southern Switzerland - Ente Ospedaliero Cantonale (EOC)

Lugano, , Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Alain Kaelin, Prof

Role: CONTACT

alain.kaelin@eoc.ch

+41 (0)91 811 62 57

Ilaria Bertaina, MD

Role: CONTACT

ilaria.bertaina@eoc.ch

+41 (0)91 811 63 74

Facility Contacts

Alain Kaelin, Prof.

Role: primary

alain.kaelin@eoc.ch

+41 (0)91 811 62 57

Ilaria Bertaina, MD

Role: backup

ilaria.bertaina@eoc.ch

+41 (0)91 811 69 15 -

Other Identifiers

NSI-SAF-001

Identifier Type: -

Identifier Source: org_study_id