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Safinamide in Levodopa Induced Dyskinesia in Parkinson's Disease Subjects

NCT01113320 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2013-03-29

No results posted yet for this study

Summary

Approximately twenty four (24) subjects will participate in this research trial. The research trial will be conducted in approximately twelve (12) medical centers in the following countries: Germany, France, South Africa, Austria and Canada. The research trial will last until December 2011.

Conditions

Interventions

DRUG

Placebo

Evaluable dose levels are 100 mg (8 days), 200 mg (10 days), and 300 mg (42 days). Intermediate dose levels are 150 mg (Study days 9-11) and 250 mg (Study days 23-25) and have a duration of three days. Safinamide and identical Placebo will be provided in tablets equivalent of 50 mg in blisters. Dosing will be achieved using appropriate multiples of these tablet strengths

DRUG

Safinamide

Evaluable dose levels are 100 mg (8 days), 200 mg (10 days), and 300 mg (42 days). Intermediate dose levels are 150 mg (Study days 9-11) and 250 mg (Study days 23-25) and have a duration of three days. Safinamide will be provided in tablets of 50 mg in blisters. Dosing will be achieved using appropriate multiples of these tablet strengths

Sponsors & Collaborators

  • Newron Pharmaceuticals SPA

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2011-11-30
Completion
2012-01-31

Countries

  • Austria
  • Canada
  • France
  • Germany
  • South Africa

Study Locations

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Entities

Drugs
Diseases

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 NCT01113320 on ClinicalTrials.gov