Back to resultsEffect of Safinamide on Sleep Quality in Patients With Parkinson's Disease
Primary Purpose
Idiopathic Parkinson's Disease (at Later Stage)
Status
Recruiting
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Safinamide
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Parkinson's Disease (at Later Stage)
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.
Sites / Locations
- Neurocenter of Southern Switzerland - Ente Ospedaliero Cantonale (EOC)Recruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Safinamide
Arm Description
PO treatment: 2 weeks of treatment at dose 50 mg/day followed by 10 weeks at 100 mg/day
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Effect of safinamide on objective PSG sleep characterization
To determine neurophysiological sleep parameters from PSG recording
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.
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".
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.
Effect of safinamide on objective sleep parameters and motor symptoms
To measure the change in sleep parameters and motor activity during the day and the night as measured by actigraphy.
Effect of safinamide on non-motor symptoms
To measure the change in depressive symptoms as measured by (BDI-II) Beck Depression Inventory and SAS (Starkstein Apathy Scale). Total BDI-II score ranges from 0 to 63 with higher total score indicating more severe depressive symptoms. Total SAS score ranges from 0 to 42 with higher scores indicating more severe apathy.
Effect of safinamide on quality of life
To measure the change in quality of life as measured by PDQ-39 (Parkinson's Disease Questionnaire-39). PDQ-39 is scored on a scale of 0 to 100, with lower scores indicating better health and high scores more severe symptoms.
Full Information
NCT ID
NCT03968744
First Posted
April 19, 2019
Last Updated
March 29, 2023
Sponsor
Alain Kaelin
Collaborators
Clinical Trial Unit Ente Ospedaliero Cantonale
1. Study Identification
Unique Protocol Identification Number
NCT03968744
Brief Title
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
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 18, 2019 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Alain Kaelin
Collaborators
Clinical Trial Unit Ente Ospedaliero Cantonale
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Parkinson's Disease (at Later Stage)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Safinamide
Arm Type
Experimental
Arm Description
PO treatment: 2 weeks of treatment at dose 50 mg/day followed by 10 weeks at 100 mg/day
Intervention Type
Drug
Intervention Name(s)
Safinamide
Other Intervention Name(s)
Xadago
Intervention Description
Safinamide taken per Os for 12 weeks
Primary Outcome Measure Information:
Title
Effect of safinamide on overall sleep quality
Description
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 Outcome Measure Information:
Title
Effect of safinamide on objective PSG sleep characterization
Description
To determine neurophysiological sleep parameters from PSG recording
Time Frame
12 weeks
Title
Effect of safinamide on subjective sleep quality and sleepiness
Description
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
Title
Effect of safinamide on objective motor activity
Description
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
Title
Effect of safinamide on subjective motor activity
Description
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
Title
Effect of safinamide on objective sleep parameters and motor symptoms
Description
To measure the change in sleep parameters and motor activity during the day and the night as measured by actigraphy.
Time Frame
12 weeks
Title
Effect of safinamide on non-motor symptoms
Description
To measure the change in depressive symptoms as measured by (BDI-II) Beck Depression Inventory and SAS (Starkstein Apathy Scale). Total BDI-II score ranges from 0 to 63 with higher total score indicating more severe depressive symptoms. Total SAS score ranges from 0 to 42 with higher scores indicating more severe apathy.
Time Frame
12 weeks
Title
Effect of safinamide on quality of life
Description
To measure the change in quality of life as measured by PDQ-39 (Parkinson's Disease Questionnaire-39). PDQ-39 is scored on a scale of 0 to 100, with lower scores indicating better health and high scores more severe symptoms.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alain Kaelin, Prof
Phone
+41 (0)91 811 62 57
Email
alain.kaelin@eoc.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Ilaria Bertaina, MD
Phone
+41 (0)91 811 63 74
Email
ilaria.bertaina@eoc.ch
Facility Information:
Facility Name
Neurocenter of Southern Switzerland - Ente Ospedaliero Cantonale (EOC)
City
Lugano
ZIP/Postal Code
6900
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alain Kaelin, Prof.
Phone
+41 (0)91 811 62 57
Email
alain.kaelin@eoc.ch
First Name & Middle Initial & Last Name & Degree
Ilaria Bertaina, MD
Phone
+41 (0)91 811 69 15 -
Email
ilaria.bertaina@eoc.ch
First Name & Middle Initial & Last Name & Degree
Mauro Manconi, Prof.
First Name & Middle Initial & Last Name & Degree
Ilaria Bertaina, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effect of Safinamide on Sleep Quality in Patients With Parkinson's Disease
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