NCT01028586

MOTION, Safinamide in Early Idiopathic Parkinson's Disease (IPD), as add-on to Dopamine Agonist (Extension of Trial 27918)

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 507 (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, extension trial, 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 objective is to evaluate the time to first intervention, as some previous data suggested that safinamide may delay the need for further dopaminergic supplementation.

Conditions

• Idiopathic Parkinson's Disease

Interventions

Type	Name	Description
DRUG	Safinamide, MAO-B inhibitor	Safinamide, MAO-B inhibitor 50 mg: once-daily orally for 78 weeks in addition to their dose of DA-agonist.
DRUG	Safinamide, MAO-B inhibitor	Safinamide, MAO-B inhibitor 100 mg: once-daily orally for 78 weeks in addition to their dose of DA-agonist.
DRUG	Placebo	matching placebo tablets

Timeline

• Start date: 2009-10-01
• Primary completion: 2012-05-01
• First posted: 2009-12-09
• Last updated: 2013-03-29

Locations

1 site across 1 country: Switzerland