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

NCT00605683 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 679

Last updated 2013-10-29

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, 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

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

Sponsors & Collaborators

  • Newron Pharmaceuticals SPA

    lead INDUSTRY

Principal Investigators

  • Jonathan Willmer, MD · Merck Serono S.A., Geneva

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2012-01-31
Completion
2012-03-31

Countries

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

Study Locations

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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 NCT00605683 on ClinicalTrials.gov