Impact of Safinamide on Sleep Quality in Parkinson's Disease Patients
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
This study tests if the medication Safinamide can improve sleep quality for adults with Parkinson's Disease who have trouble with motor fluctuations.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 23 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ente Ospedaliero Cantonale, Bellinzona Academic / other |
| Locations | 1 site (Lugano) |
| Trial ID | NCT03968744 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of Safinamide on sleep quality in adults with idiopathic Parkinson's Disease who experience motor fluctuations. Participants will undergo a baseline assessment followed by a treatment regimen that starts with 50 mg/day of Safinamide for two weeks, increasing to 100 mg/day for an additional ten weeks if tolerated. The study includes objective measurements of sleep quality through polysomnography (PSG) and actigraphy, along with subjective assessments via questionnaires. A follow-up visit will occur four weeks after treatment completion to ensure safety.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with fluctuating idiopathic Parkinson's Disease and sleep disturbances.
Not a fit: Patients with early-stage Parkinson's Disease or severe sleep-related breathing disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve sleep quality for patients suffering from Parkinson's Disease.
How similar studies have performed: Other studies have shown promising results with Safinamide in managing Parkinson's Disease symptoms, suggesting potential for success in this approach.
Eligibility criteria
Show full 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.
Where this trial is running
Lugano
- Neurocenter of Southern Switzerland - Ente Ospedaliero Cantonale (EOC) — Lugano, Switzerland (Recruiting)
Study contacts
- Study coordinator: Alain Kaelin, Prof
- Email: alain.kaelin@eoc.ch
- Phone: +41 (0)91 811 62 57
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.