NCT00605683

MOTION, Safinamide in Early IPD, as add-on to Dopamine Agonist

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 679 (actual)
• Sponsor: Newron Pharmaceuticals SPA · Industry
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Idiopathic Parkinson's Disease

Interventions

Type	Name	Description
DRUG	Safinamide (as add-on therapy)	Safinamide, (S)-(+)-2-\[4-(3-fluorobenzyloxy) benzylamino\] propanamide methanesulfonate, is an a-aminoamide derivative
DRUG	Safinamide (as add-on therapy)	Safinamide add-on therapy with subjects with IPD treated with single dopamine agonist
DRUG	Safinamide (as add-on therapy)	Safinamide add-on therapy with subjects with IPD treated with single dopamine agonist

Timeline

• Start date: 2007-11-01
• Primary completion: 2012-01-01
• Completion: 2012-03-01
• First posted: 2008-01-31
• Last updated: 2013-10-29

Locations

125 sites across 20 countries: United States, Argentina, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czechia, Finland, Germany, India, Italy, Mexico, Peru, Poland, Portugal, Slovakia, South Africa, Spain