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

NCT03968744 | Terminated Phase 4

• 1 other identifier: NSI-SAF-001
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Parkinson's Disease (at Later Stage)

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (7)

• Effect of safinamide on objective PSG sleep characterization

  12 weeks

• Effect of safinamide on subjective sleep quality and sleepiness

  12 weeks

• Effect of safinamide on objective motor activity

  12 weeks

• Effect of safinamide on subjective motor activity

  12 weeks

• Effect of safinamide on objective sleep parameters and motor symptoms

  12 weeks

Study Arms (1)

Safinamide

EXPERIMENTAL

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

Drug: Safinamide

Interventions

Safinamide DRUG

Safinamide taken per Os for 12 weeks

Also known as: Xadago

Safinamide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Written informed consent
• Willingness and ability to participate in the trial

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alain Kaelin: lead
• Clinical Trial Unit Ente Ospedaliero Cantonale: collaborator

Study Sites (1)

Neurocenter of Southern Switzerland - Ente Ospedaliero Cantonale (EOC)

Lugano, 6900, Switzerland

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

safinamide

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Neurocenter of Southern Switzerland

Study Record Dates

• First Submitted: April 19, 2019
• First Posted: May 30, 2019
• Study Start: February 18, 2019
• Primary Completion: February 2, 2026
• Study Completion: February 2, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

CH (1)