NCT01782222

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

A Multicenter, Multinational, Double-Blind, Placebo-Controlled, 3-Arm, Phase 4 Study To Evaluate The Efficacy Of Rotigotine On Parkinson's Disease-Associated Apathy, Motor Symptoms, And Mood

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: UCB BIOSCIENCES GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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)

Timeline

• Start date: 2013-02-01
• Primary completion: 2014-01-01
• Completion: 2014-03-01
• First posted: 2013-02-01
• Last updated: 2018-08-31
• Results posted: 2015-01-19

Locations

42 sites across 7 countries: United States, Austria, Hungary, Poland, Slovakia, Slovenia, Spain