Condition or disease | Intervention/treatment | Phase |
---|---|---|
Idiopathic Parkinson's Disease (at Later Stage) | Drug: Safinamide | Phase 4 |
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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 23 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | February 18, 2019 |
Estimated Primary Completion Date : | April 30, 2021 |
Estimated Study Completion Date : | April 30, 2021 |
Arm | Intervention/treatment |
---|---|
Experimental: Safinamide
PO treatment: 2 weeks of treatment at dose 50 mg/day followed by 10 weeks at 100 mg/day
|
Drug: Safinamide
Safinamide taken per Os for 12 weeks
Other Name: Xadago
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Alain Kaelin, Prof | +41 (0)91 811 62 57 | alain.kaelin@eoc.ch | |
Contact: Ilaria Bertaina, MD | +41 (0)91 811 63 74 | ilaria.bertaina@eoc.ch |
Switzerland | |
Neurocenter of Southern Switzerland - Ente Ospedaliero Cantonale (EOC) | Recruiting |
Lugano, Switzerland, 6900 | |
Contact: Alain Kaelin, Prof. +41 (0)91 811 62 57 alain.kaelin@eoc.ch | |
Contact: Ilaria Bertaina, MD +41 (0)91 811 69 15 - ilaria.bertaina@eoc.ch | |
Sub-Investigator: Mauro Manconi, Prof. | |
Sub-Investigator: Ilaria Bertaina, MD |
Tracking Information | |||||||||
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First Submitted Date ICMJE | April 19, 2019 | ||||||||
First Posted Date ICMJE | May 30, 2019 | ||||||||
Last Update Posted Date | April 29, 2020 | ||||||||
Actual Study Start Date ICMJE | February 18, 2019 | ||||||||
Estimated Primary Completion Date | April 30, 2021 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Effect of Safinamide on Sleep Quality in Patients With Parkinson's Disease | ||||||||
Official Title ICMJE | 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 | ||||||||
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. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 4 | ||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Idiopathic Parkinson's Disease (at Later Stage) | ||||||||
Intervention ICMJE | Drug: Safinamide
Safinamide taken per Os for 12 weeks
Other Name: Xadago
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Study Arms ICMJE | Experimental: Safinamide
PO treatment: 2 weeks of treatment at dose 50 mg/day followed by 10 weeks at 100 mg/day
Intervention: Drug: Safinamide
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
23 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | April 30, 2021 | ||||||||
Estimated Primary Completion Date | April 30, 2021 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Switzerland | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03968744 | ||||||||
Other Study ID Numbers ICMJE | NSI-SAF-001 | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Alain Kaelin, Ente Ospedaliero Cantonale, Bellinzona | ||||||||
Study Sponsor ICMJE | Alain Kaelin | ||||||||
Collaborators ICMJE | Clinical Trial Unit Ente Ospedaliero Cantonale | ||||||||
Investigators ICMJE | Not Provided | ||||||||
PRS Account | Ente Ospedaliero Cantonale, Bellinzona | ||||||||
Verification Date | April 2020 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |