Overnight Switch From Rasagiline To Safinamide In Fluctuating Patients With Parkinson's Disease: A Tolerability And Safety Study

RP 05/17

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

2018-05-01

2019-03-31

2019-05-31

Completed

Early phase I

20

Inclusion Criteria: * Patients able to comprehend and provide consent form * Patients with idiopathic Parkinson's disease diagnosed according to the UK Brain Bank criteria * Patients in mid-to late stage of the disease (Hoehn \& Yahr: between the stage 2 and 4 in on state). * Patients suffering from motor fluctuations * Patients must have a good response to levodopa in the opinion of the investigators (evaluated as improvement ≥ 30% of the UPDRS scores) * Stable dosage of antiparkinsonian medication for at least 4 weeks prior to study enrollment * Female patients in post-menopausal state; women of childbearing potential must use an acceptable method of contraception Exclusion Criteria: * Atypical Parkinsonism * Any significant psychiatric, metabolic and systemic concomitant disease * Patients with clinically significant out of range laboratory values * Patients participating in a clinical trial in the last 6 weeks * Patients with moderate-severe cognitive decline not able to provide consent form * Patients currently lactating or pregnant or planning to become pregnant during the duration of the study * Patients for whom Xadago is contraindicated according to the current SmPC

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 20, 'type': 'ACTUAL'}}

2024-04-10