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
Zusammenfassung der Studie
The study aims to verify whether the medication Safinamide (Xadago®) is capable of improving sleep quality and other non-motor symptoms in patients with moderate to advanced Parkinson's disease who exhibit sleep disturbances and show a fluctuating response to levodopa therapy, thus transitioning from periods of relative well-being (ON) to phases of greater "motor block" (OFF). In patients with Parkinson's disease, there is an alteration in the functioning of certain brain regions involved in the production and release of a substance called dopamine, which thus becomes "lacking". Xadago® is a medication that can block the degradation of dopamine, increasing its amount in the brain and thereby improving the patient's motor symptoms (referred to as dopaminergic effect). Additionally, Xadago® also acts through other mechanisms (regulation of sodium and glutamate channels) and may improve sleep and other non-motor symptoms (referred to as non-dopaminergic effect).
(BASEC)
Untersuchte Intervention
Xadago® is administered according to the approval. Treatment begins at a dose of 50 mg per day for 2 weeks, after which the dose will be increased to 100 mg per day for 10 weeks.
(BASEC)
Untersuchte Krankheit(en)
Patients with moderate to advanced Parkinson's disease who exhibit sleep disturbances
(BASEC)
• Age ≥ 18 years • Patients with fluctuating idiopathic PD according to UK Brain Bank criteria • Hoehn and Yahr II to IV under treatment • Sleep disturbances with a Pittsburgh Sleep Quality Index (PSQI) > 5 • Treatment with L-DOPA, alone or with other dopaminergic medications, at a stable dose for at least 28 days prior to inclusion • written informed consent • Availability and ability to participate in the trial (BASEC)
Ausschlusskriterien
• 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 respiratory disorders associated with sleep (apnea-hypopnea index > 30/h) • Dementia (MoCA < 26) • Severe depression (BDI-II > 29) • Other severe psychiatric symptoms such as active psychosis or significant hallucinations • Any previous or concomitant serious medical condition or clinical laboratory abnormality that, in the clinical judgment of the investigators, does not allow patient participation in the study • Moderate or severe liver insufficiency, any type of retinopathy and/or any condition considered a contraindication according to the SmPC of safinamide • Any concomitant treatment not permitted or contraindicated in the SmPC of safinamide • Pregnant or breastfeeding women • Lack of reliable contraception (BASEC)
Studienstandort
Lugano
(BASEC)
Sponsor
Neurocenter of Southern Switzerland – Ente Ospedaliero Cantonale (EOC) Regional Hospital of Lugano Via Tesserete 46 6900 Lugano, Switzerland
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Prof. Dr. med. Dr. phil. med. Alain Kaelin
+41 (0)91 811 62 57
alain.kaelin@cluttereoc.chNeurocenter of Southern Switzerland – Ente Ospedaliero Cantonale (EOC) Regional Hospital of Lugano Via Tesserete 46 6900 Lugano, Switzerland
(BASEC)
Allgemeine Auskünfte
+41 (0)91 811 62 57+41 (0)91 811 62 57
alain.kaelin@cluttereoc.chalain.kaelin@cluttereoc.ch(ICTRP)
Wissenschaftliche Auskünfte
+41 (0)91 811 62 57;+41 (0)91 811 62 57
alain.kaelin@cluttereoc.ch(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Tessin
(BASEC)
Datum der Bewilligung durch die Ethikkommission
15.02.2019
(BASEC)
ICTRP Studien-ID
NCT03968744 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
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 (BASEC)
Wissenschaftlicher Titel
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 (ICTRP)
Öffentlicher Titel
Effect of Safinamide on Sleep Quality in Patients With Parkinson's Disease (ICTRP)
Untersuchte Krankheit(en)
Idiopathic Parkinson's Disease (at Later Stage) (ICTRP)
Untersuchte Intervention
Drug: Safinamide (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Ein-/Ausschlusskriterien
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. (ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
Effect of safinamide on overall sleep quality (ICTRP)
Effect of safinamide on objective PSG sleep characterization;Effect of safinamide on subjective sleep quality and sleepiness;Effect of safinamide on objective motor activity;Effect of safinamide on subjective motor activity;Effect of safinamide on objective sleep parameters and motor symptoms;Effect of safinamide on non-motor symptoms;Effect of safinamide on quality of life (ICTRP)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
Clinical Trial Unit Ente Ospedaliero Cantonale (ICTRP)
Weitere Kontakte
Alain Kaelin, Prof;Alain Kaelin, Prof., alain.kaelin@eoc.ch, +41 (0)91 811 62 57;+41 (0)91 811 62 57 (ICTRP)
Sekundäre IDs
NSI-SAF-001 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/study/NCT03968744 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar