NCT00522379

Trial to Assess Parkinson's Disease (PD) Symptom Control to Four Doses of Rotigotine in a Transdermal Patch

A Multicenter, Randomized, Double-blind, Placebo-controlled, 5-arm, Parallel-group Trial to Assess Rotigotine Transdermal System Dose Response in Subjects With Advanced-stage Parkinson's Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 514 (actual)
• Sponsor: UCB Pharma · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to show Rotigotine dose response at four doses of Rotigotine used with L-dopa in treating advanced stage Parkinson's disease.

Detailed description

To maintain treatment blind, two different active patch sizes were used (10 cm\^2 \& 20 cm\^2). Placebo patches matched according to size and appearance. During the trial subjects applied up to three patches, active and placebo, to achieve their assigned daily dose.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	Rotigotine	2 mg/24 hr (one 10 cm\^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
DRUG	Rotigotine	4 mg/24 hr (one 20 cm\^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
OTHER	Placebo	Placebo transdermal patch applied daily
DRUG	Rotigotine	6 mg/24 hr (one 10 cm\^2 \& one 20 cm\^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
DRUG	Rotigotine	8 mg/24 hr (two 10 cm\^2 \& one 20 cm\^2) transdermal patches applied daily for titration and maintenance period - 16 weeks

Timeline

• Start date: 2007-07-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2007-08-29
• Last updated: 2014-10-27
• Results posted: 2012-12-10

Locations

77 sites across 5 countries: United States, Chile, India, Mexico, Peru