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

• Register: ClinicalTrials.gov
• Last refreshed on: 25 March 2024
• Main ID: NCT03968744
• Date of registration: 19/04/2019
• Prospective Registration: No
• Primary sponsor: Alain Kaelin
• Public title: Effect of Safinamide on Sleep Quality in Patients With Parkinson's Disease
• Scientific 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
• Date of first enrolment: February 18, 2019
• Target sample size: 23
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03968744
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Switzerland

Contacts

• Name: Alain Kaelin, Prof.

• Name: Alain Kaelin, Prof

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Idiopathic Parkinson's Disease (at Later Stage)

Intervention(s)

Drug: Safinamide

Primary Outcome(s)

Effect of safinamide on overall sleep quality [Time Frame: 12 weeks]

Secondary Outcome(s)

Effect of safinamide on quality of life [Time Frame: 12 weeks]

Effect of safinamide on subjective motor activity [Time Frame: 12 weeks]

Effect of safinamide on non-motor symptoms [Time Frame: 12 weeks]

Effect of safinamide on objective motor activity [Time Frame: 12 weeks]

Effect of safinamide on objective sleep parameters and motor symptoms [Time Frame: 12 weeks]

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]

Secondary ID(s)

NSI-SAF-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Clinical Trial Unit Ente Ospedaliero Cantonale