MedTrace Logo

Randomized Evaluation of the 24-Hour Coverage: Efficacy of Rotigotine

NCT00474058 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 287

Last updated 2015-06-22

Study results available
· View outcomes & findings →

Summary

The objective of this trial is to assess the effects of transdermal rotigotine on the control of early morning motor function and sleep disorders compared to placebo in subjects with idiopathic Parkinsons´s disease. In addition, effects of rotigotine on specific nocturnal and non-motor symptoms of Parkinson´s disease will be evaluated.

Conditions

Interventions

DRUG

Rotigotine

Rotigotine transdermal patches: 10cm2 (2mg/24h); 20cm2 (4mg/24h); 30cm2 (6mg/24h); 40cm2 (8mg/24h) Optimal dosing: The maximum Rotigotine dose allowed is 16mg/24h

OTHER

Placebo

Placebo transdermal patches

Sponsors & Collaborators

  • UCB Pharma

    lead INDUSTRY

Principal Investigators

  • UCB Clinical Trial Call Center · +1 877 822 9493 (UCB)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • United States
  • Australia
  • Austria
  • Finland
  • Germany
  • Hungary
  • Italy
  • New Zealand
  • Poland
  • South Africa
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT00474058 on ClinicalTrials.gov