MedTrace Logo

Trial to Evaluate The Efficacy Of Rotigotine on Parkinson's Disease-Associated Motor Symptoms And Apathy

NCT01782222 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2018-08-31

Study results available
· View outcomes & findings →

Summary

This trial is being conducted to assess the effects of Rotigotine over Placebo on improvement of Apathy and motor symptoms in subjects with early-stage and advanced stage idiopathic Parkinson´s Disease.

Conditions

  • Idiopathic Parkinson's Disease

Interventions

DRUG

Rotigotine

Rotigotine, transdermal patches: 10 cm\^2 (2 mg / 24 hours); 20 cm\^2 (4 mg / 24 hours); 30 cm\^2 (6 mg / 24 hours); 40 cm\^2 (8 mg / 24 hours) The maximum Rotigotine dose allowed is 8 mg / 24 hours or 16 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours or 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)

OTHER

Placebo

Placebo, matching transdermal patches Duration: up to 21 weeks (including de-escalation)

Sponsors & Collaborators

  • UCB BIOSCIENCES GmbH

    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
2013-02-28
Primary Completion
2014-01-31
Completion
2014-03-31

Countries

  • United States
  • Austria
  • Hungary
  • Poland
  • Slovakia
  • Slovenia
  • Spain

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 NCT01782222 on ClinicalTrials.gov