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

NCT00627640 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 549

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 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

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

Sponsors & Collaborators

  • Newron Pharmaceuticals SPA

    lead INDUSTRY

Principal Investigators

  • Algirdas Kakarieka, 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
2009-02-28
Primary Completion
2012-01-31
Completion
2012-03-31

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

Study Locations

More Related Trials

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 NCT00627640 on ClinicalTrials.gov