NCT00474058

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

Phase 3B, Multicenter, Multinational, Double-Blind, Placebo Controlled, 2-Arm Trial to Evaluate the Effect of the 24-Hour Transdermal Delivery of Rotigotine on the Control of Early Morning Motor Function, Sleep Quality, Nocturnal Symptoms, and Non-Motor Symptoms in Subjects With Idiopathic Parkinson's Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 287 (actual)
• Sponsor: UCB Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The objective of this trial is to assess the effects of 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. After a Screening Period of up to 28 days subjects will be hospitalized for two nights. After the second overnight stay, subjects will be randomly assigned either to rotigotine patch or placebo patch. Afterwards patients will be titrated to their optimal dose. After subjects have reached their optimal dose (or the highest dose) they will be maintained on this dose for a certain period. At the end of maintenance the subjects will be hospitalized for two nights. Afterwards the doses will be continuously decreased. Efficacy will be assessed by application of sleep quality scores, motor examination scores, and scores to evaluate non-motor symptoms of Parkinsons. Safety assessments include adverse events, 12-lead electrocardiograms, blood pressure and heart rate assessments, and laboratory checks.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2007-05-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2007-05-16
• Last updated: 2015-06-22
• Results posted: 2010-04-12

Locations

47 sites across 12 countries: United States, Australia, Austria, Finland, Germany, Hungary, Italy, New Zealand, Poland, South Africa, Spain, United Kingdom