A Phase III, Double-blind, Placebo-controlled Randomised Trial to Determine the Efficacy and Safety of a Low (50 mg/Day) and High (100 mg/Day) Dose of Safinamide, as add-on Therapy, in Subjects With Early Idiopathic Parkinson's Disease Treated With a Stable Dose of a Single Dopamine Agonist (MOTION)

NCT00605683 Phase 3 COMPLETED

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.

Details

Lead sponsor	Newron Pharmaceuticals SPA
Phase	Phase 3
Status	COMPLETED
Enrolment	679
Start date	2007-11
Completion	2012-03

Conditions

• Idiopathic Parkinson's Disease

Interventions

• Safinamide (as add-on therapy)
• Safinamide (as add-on therapy)
• Safinamide (as add-on therapy)

Primary outcomes

• Evaluate the changes from baseline to W24 in motor symptoms (UPDRS Section III). — 24 weeks

Countries

United States, Argentina, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czechia, Finland, Germany, India, Italy, Mexico, Peru, Poland, Portugal, Slovakia, South Africa, Spain