NCT01711866

A Phase 4, Open-label Study to Assess the Feasibility and Efficacy on Motor and Non-motor Symptoms of Switching From Pramipexole or Ropinirole to Rotigotine Transdermal Patch in Subjects With Advanced Idiopathic Parkinson's Disease

An Open-Label, Multicenter, Multinational Study to Assess the Feasibility of Switching Therapy From Pramipexole or Ropinirole to the Rotigotine Transdermal System and Its Effect on Motor and Non-Motor Symptoms in Subjects With Advanced Idiopathic Parkinson's Disease Phase 4

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: UCB BIOSCIENCES GmbH · Industry
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety and feasibility of switching subjects with advanced Parkinson's Disease (PD) from Pramipexole or Ropinirole to Rotigotine and to assess the effects of Rotigotine on motor and non-motor symptoms of Parkinson's Disease in subjects switched from previous treatment with either Pramipexole or Ropinirole.

Conditions

• Advanced Idiopathic Parkinson's Disease

Interventions

Type	Name	Description
DRUG	Rotigotine	Rotigotine up to 16 mg / 24 hours, 4 weeks.

Timeline

• Start date: 2012-09-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2012-10-22
• Last updated: 2014-04-07
• Results posted: 2014-04-07

Locations

21 sites across 5 countries: United States, Malaysia, Singapore, South Korea, Taiwan