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

NCT01028586 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 507

Last updated 2013-03-29

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Newron Pharmaceuticals SPA

    lead INDUSTRY

Principal Investigators

  • Jonathan Willmer, MD · EMD Serono

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2012-05-31

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01028586 on ClinicalTrials.gov