MOTION, Safinamide in Early IPD, as add-on to Dopamine Agonist
Status:
Completed
Trial end date:
2012-03-01
Target enrollment:
Participant gender:
Summary
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.