NCT00627640

Safinamide in Idiopathic Parkinson's Disease (IPD) With Motor Fluctuations, as add-on to Levodopa

A Phase III, Double-blind, Placebo-controlled, Randomised Trial to Determine the Efficacy and Safety of a Dose Range of 50 to 100 mg/Day of Safinamide, as add-on Therapy, in Subjects With Idiopathic Parkinson's Disease With Motor Fluctuations, Treated With a Stable Dose of Levodopa and Who May be Receiving Concomitant Treatment With Stable Doses of a Dopamine Agonist, an Anticholinergic and/or Amantadine

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 549 (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 dopamine-containing 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. Safinamide is an inhibitor of MAO-B. This is a phase III trial to evaluate the efficacy and safety of safinamide (50 and 100 mg p.o. q.a.m.) compared to placebo as add-on therapy to a stable dose to levodopa in subjects with advance idiopathic Parkinson's Disease. The principal efficacy measure is the increase in mean daily "on" time during the 18-hr diary recording period.

Conditions

• Idiopathic Parkinson's Disease

Interventions

Type	Name	Description
DRUG	Safinimide 50-100 mg/day	Safinamide, (S)-(+)-2-\[4-(3-fluorobenzyloxy) benzylamino\] propanamide methanesulfonate, is an a-aminoamide derivative
DRUG	Matching Placebo	Matching Placebo

Timeline

• Start date: 2009-02-01
• Primary completion: 2012-01-01
• Completion: 2012-03-01
• First posted: 2008-03-03
• Last updated: 2013-03-29

Locations

121 sites across 21 countries: United States, Australia, Austria, Belgium, Canada, Estonia, France, Germany, Hungary, India, Israel, Malaysia, Netherlands, New Zealand, Slovakia, South Korea, Spain, Switzerland, Taiwan, Thailand, United Kingdom