Parkinson's disease is a major neurodegenerative disorder in which there is a progressive loss of nigrostriatal dopaminergic 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 man. This is a double-blind, placebo-controlled, extension trial, parallel-group, randomised, multi-centre, multi national, Phase III trial, comparing two doses of safinamide (50 and 100 mg p.o. q.a.m.) versus placebo as add-on therapy to a stable dose of a single dopamine agonist in subjects with early idiopathic Parkinson's Disease. The principal objective is to evaluate the time to first intervention, as some previous data suggested that safinamide may delay the need for further dopaminergic supplementation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
507
Safinamide, MAO-B inhibitor 50 mg: once-daily orally for 78 weeks in addition to their dose of DA-agonist.
Safinamide, MAO-B inhibitor 100 mg: once-daily orally for 78 weeks in addition to their dose of DA-agonist.
matching placebo tablets
Enquire Central Contact
Geneva, Switzerland
Time from baseline to first intervention, i.e., change in the dose of Dopamine (DA) agonist, addition of another DA-agonist, levodopa, or other Parkinson Disease (PD) therapy, or discontinuation due to lack of efficacy
Time frame: Week 78
Proportion of subjects requiring intervention
Time frame: Week 78
Unified Parkinson's Disease Rating Scale (UPDRS) Section III (motor) score change from baseline to week 78
Time frame: Week 78
Unified Parkinson's Disease Rating Scale (UPDRS) Section II (ADL) score change from baseline to week 78
Time frame: Week 78
Clinical Global impression (CGI) - Change scale score, change from Day 0 of Trial 27918 to week 78
Time frame: Week 78
Clinical Global impression (CGI) - Severity scale score change from baseline to week 78
Time frame: Week 78
EuroQoL 5D (EQ-5D) score change from baseline to week 78
Time frame: Week 78
Parkinson's Disease Questionnaire (PDQ-39) score change from baseline to week 78
Time frame: Week 78
Cogtest® PD battery test score change from baseline to week 78
Time frame: Week 78
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