Idiopathic Parkinson's Disease (at Later Stage)Phase 4NCT03968744
Effect of Safinamide on Sleep Quality in Patients With Parkinson's Disease
A Phase 4 study testing Safinamide in people with Idiopathic Parkinson's Disease (at Later Stage), run by Alain Kaelin at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Parkinson's Disease (at Later Stage)
- What is being tested?
- Safinamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteSwitzerland
- Study dates
- 18 Feb 2019to 2 Feb 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Neurocenter of Southern Switzerland - Ente Ospedaliero Cantonale (EOC)
Lugano, 6900
About this study
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
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.
Read the 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.
- Being tested
- Safinamide
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SafinamideDrug
Also called Xadago
Safinamide taken per Os for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Safinamide | Experimental | PO treatment: 2 weeks of treatment at dose 50 mg/day followed by 10 weeks at 100 mg/day Receives: Drug: Safinamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (7)
Effect of safinamide on objective PSG sleep characterization
To determine neurophysiological sleep parameters from PSG recording
Measured: 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.
Measured: 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".
Measured: 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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start18 Feb 2019
- Primary completion2 Feb 2026
- Study completion2 Feb 2026
Why it stopped: insufficient eligible patients for enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Parkinson's Disease (at Later Stage)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alain Kaelin
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Trial Unit Ente Ospedaliero Cantonale
- Responsible party
- Sponsor-investigator, Alain Kaelin, Ente Ospedaliero Cantonale, Bellinzona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03968744
- Sponsor's protocol ID
- NSI-SAF-001
- Status last verified
- Mar 2026
- First submitted
- 19 Apr 2019
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03968744
- Acronym / sponsor ID
- NSI-SAF-001
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient eligible patients for enrollment
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Alain KaelinUniversity, hospital or other
- Collaborators
- Clinical Trial Unit Ente Ospedaliero Cantonale
- Study start
- 18 Feb 2019 (actual)
- Primary completion
- 2 Feb 2026 (actual)
- Study completion
- 2 Feb 2026 (actual)
- First posted
- 30 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Safinamide | Experimental | Drug: SafinamidePO treatment: 2 weeks of treatment at dose 50 mg/day followed by 10 weeks at 100 mg/day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SafinamideAlso: XadagoSafinamide taken per Os for 12 weeks | Drug | Safinamide |
Primary outcome
Effect of safinamide on overall sleep quality
Time frame: 12 weeks
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.
7 secondary outcomes
Effect of safinamide on objective PSG sleep characterization
Time frame: 12 weeks
Effect of safinamide on subjective sleep quality and sleepiness
Time frame: 12 weeks
Effect of safinamide on objective motor activity
Time frame: 12 weeks
Effect of safinamide on subjective motor activity
Time frame: 12 weeks
Effect of safinamide on objective sleep parameters and motor symptoms
Time frame: 12 weeks
Effect of safinamide on non-motor symptoms
Time frame: 12 weeks
Effect of safinamide on quality of life
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: insufficient eligible patients for enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Safinamide in people with Idiopathic Parkinson's Disease (at Later Stage), run by Alain Kaelin at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: insufficient eligible patients for enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of safinamide on overall sleep quality (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.