Parkinson's Disease (PD) is a major neurodegenerative disorder in which there is a progressive loss of dopamine-containing neurons. The understanding that PD is a syndrome of dopamine (DA) deficiency led to the introduction in the clinical practice of L-dopa, a precursor of DA that crosses the blood brain barrier, and also to the use of selective inhibitors of MAO-B, the major DA metabolising enzyme in humans. Safinamide is an inhibitor of MAO-B. This study is to evaluate the long term safety and tolerability of safinamide in PD patients, that have already completed a previous clinical study with Safinamide. The physical and neurological conditions as well as other safety parameters will get compared from baseline to subsequent visits.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
964
The Investigational Medicinal Product will be provided by the Sponsor in the form of tablets at dosage strengths of safinamide 50 mg (small - 7 mm) or safinamide 100 mg (large - 9 mm). Trial Medication is to be taken once daily, in the morning.
Research Site
Timuș, Romania
Change from baseline in Physical Exams
Time frame: Anticipated time frame up to 3 years
Change from baseline in Neurologic Exams
Time frame: Anticipated time frame up to 3 years
Change from baseline in Vital Signs
Time frame: Anticipated time frame up to 3 years
Change from baseline in Laboratory Evaluations
Time frame: Anticipated time frame up to 3 years
Change from baseline in Electrocardiograms
Time frame: Anticipated time frame up to 3 years
Summary of Participants who had Adverse Experiences
Time frame: Anticipated time frame up to 3 years
Change from baseline in Unified Parkinson's Disease Rating Scale (UPDRS)
Time frame: Anticipated time frame up to 3 years
Change from baseline in Dermatologic Exams
Time frame: Anticipated time frame up to 3 years
Change from baseline in Ophthalmologic Exams
Time frame: Anticipated time frame up to 3 years
Change from baseline in Health Resource Utilisation
Time frame: Anticipated time frame up to 3 years
Change from baseline in EuroQol Group EQ-5D™ Quality of Life Scale
Time frame: Anticipated time frame up to 3 years
Change from baseline in Parkinson Disease Questionnaire 39 (PDQ-39)
Time frame: Anticipated time frame up to 3 years
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