A Phase 4 interventional study of Safinamide in Parkinson Disease, sponsored by IRCCS San Raffaele Roma. Completed at 1 site in Italy. Open to participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-04-10.
Sponsored by IRCCS San Raffaele Roma · Phase 4, Interventional, and Treatment
Rasagiline label report the indication to wait at least 14 days between discontinuation of rasagiline and initiation of another MAO inhibitor. This results in a major inconvenience for Parkinsonian patients (PD) due to their clinical worsening. Safinamide is a reversible MAO-B inhibitor, characterized by a good safety profile. In clinical practice safinamide is often introduced instead of rasagiline following an overnight switch. The aim of this study is to explore the safety and tolerability of the immediate switch from rasagiline (irreversible MAO-B inhibitor) to safinamide, with the expectation that there will be no adverse events or increased risk of hypertensive crisis for patients with PD or signs of serotonin syndrome
Objective: The aim of this study is to verify safety and tolerability of the immediate switch from rasagiline to safinamide trough monitoring of BP by 24-hour Holter recording. The primary objective of the study will be achieved if the mean BP will not increase by >10 mmHg in the studied population.
Methods: This is an open-label, single-centre study conducted at IRCCS San Raffaele Pisana. Study population included patients with idiopathic PD in the mid-late stage of the disease, suffering from motor fluctuation, on stable treatment with rasagiline and Levodopa (alone or in combination with other anti-parkinsonian medication). The protocol contemplates five visits during six weeks, with two 24-hour Holter recording (first in rasagiline and second in first-day of safinamide therapy), monitoring typical symptoms of the serotonin syndrome.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 20 is below the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →IRCCS San Raffaele Roma is the lead sponsor of 63 studies on the registry; 28 are open to participants now.
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Exclusion Criteria:
Overnight switch from rasagiline 1 mg OD to safinamide 50 mg OD
Drug: Safinamide
Overnight switch from rasagiline 1 mg OD to safinamide 50 mg OD
Also known as: Xadago
Change From Baseline in Blood Pressure (BP)
Monitoring of BP by 24-hour Holter (increase by \>10 mmHg)
Time frame: through study completion, an average of 8 weeks
Clinical change in UPDRS compared to baseline
Unified Parkinson's Disease rating scale (UPDRS total score ranges between 0 - normal - to 199 points - severe)
Time frame: through study completion, an average of 8 weeks
Clinical change in H&Y compared to baseline
Hoehn and Yahr scale is a system for describing progress of Parkinson's disease (range between 1 -less affect- to 5-more affect)
Time frame: through study completion, an average of 8 weeks
Clinical change in MoCA compared to baseline
The Montreal Cognitive Assessment (MoCA) is a widely used screening assessment for detecting cognitive impairment (ranges between 0-more affect- and 30-normal)
Time frame: through study completion, an average of 8 weeks
Plan to share: Undecided
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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IRCCS San Raffaele Roma