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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Safinamide | Experimental | Overnight switch from rasagiline 1 mg OD to safinamide 50 mg OD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Safinamide | Drug | Overnight switch from rasagiline 1 mg OD to safinamide 50 mg OD |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Blood Pressure (BP) | Monitoring of BP by 24-hour Holter (increase by >10 mmHg) | through study completion, an average of 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical change in UPDRS compared to baseline | Unified Parkinson's Disease rating scale (UPDRS total score ranges between 0 - normal - to 199 points - severe) | through study completion, an average of 8 weeks |
| Clinical change in H&Y compared to baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fabrizio Stocchi, MD. PhD | IRCCS San Raffaele | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS San Raffaele | Roma | 00163 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23196982 | Background | Muller T, Hoffmann JA, Dimpfel W, Oehlwein C. Switch from selegiline to rasagiline is beneficial in patients with Parkinson's disease. J Neural Transm (Vienna). 2013 May;120(5):761-5. doi: 10.1007/s00702-012-0927-3. Epub 2012 Nov 30. | |
| 21913224 | Background | Stocchi F, Borgohain R, Onofrj M, Schapira AH, Bhatt M, Lucini V, Giuliani R, Anand R; Study 015 Investigators. A randomized, double-blind, placebo-controlled trial of safinamide as add-on therapy in early Parkinson's disease patients. Mov Disord. 2012 Jan;27(1):106-12. doi: 10.1002/mds.23954. Epub 2011 Sep 12. |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C092797 | safinamide |
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Hoehn and Yahr scale is a system for describing progress of Parkinson's disease (range between 1 -less affect- to 5-more affect) |
| 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) | through study completion, an average of 8 weeks |
| 22948897 | Background | Marquet A, Kupas K, Johne A, Astruc B, Patat A, Krosser S, Kovar A. The effect of safinamide, a novel drug for Parkinson's disease, on pressor response to oral tyramine: a randomized, double-blind, clinical trial. Clin Pharmacol Ther. 2012 Oct;92(4):450-7. doi: 10.1038/clpt.2012.128. Epub 2012 Sep 5. |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |