MOTION, Safinamide in Early IPD, as add-on to Dopamine Agonist
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, 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 efficacy measure, i.e., change in mean value of UPDRS - Section III total
score from baseline to endpoint, was chosen based on regulatory guidance and prior use in
other trials in similar populations.
Fed Study of (Parlodel®) Bromocriptine Mesylate Capsules 5 mg
The objective of this study was to assess the single-dose relative bioavailability of Mylan
Pharmaceuticals Inc. and Novartis Pharmaceuticals Corporation (Parlodel®) 5 mg bromocriptine
mesylate capsules, following the administration of a 10 mg dose, under fed conditions.
Fed Study of (Parlodel®) 2.5 mg Bromocriptine Mesylate Tablets
The objective of this study is to assess the single-dose relative bioavailability of Mylan
Pharmaceuticals Inc. and Novartis Pharmaceuticals Corporation (Parlodel®) 2.5 mg
bromocriptine mesylate tablets, following the administration of a 10 mg dose, under fed
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