Clinical Trials Directory

Trials / Terminated

TerminatedNCT00519532

Long-term Extension of RECOVER- Long-term Effect of the 24h Transdermal Delivery of Rotigotine in Subjects With Idiopathic Parkinson's Disease

A Multicenter, Multinational, Phase 3b, Open-label Extension Trial to Evaluate the Long-term Effect of the 24-hour Transdermal Delivery of Rotigotine on Motor Function, Sleep Quality, and Nocturnal and Non-motor Symptoms in Subjects With Idiopathic Parkinson's Disease

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

Summary

The objective of this open-label extension is to assess the long-term effect of the 24-hour transdermal delivery of rotigotine on motor function, sleep quality, and nocturnal and non-motor symptoms of Parkinson's disease. The long-term safety and tolerability of the rotigotine transdermal patch will also be evaluated.

Conditions

Interventions

TypeNameDescription
DRUGRotigotineRotigotine transdermal patches: 10cm2 (2mg/24h); 20cm2 (4mg/24h); 30cm2 (6mg/24h); 40cm2 (8mg/24h) Optimal dosing: The maximum rotigotine dose allowed is 16mg/24h

Timeline

Start date
2007-07-01
Primary completion
2009-05-01
Completion
2009-05-01
First posted
2007-08-22
Last updated
2014-10-27
Results posted
2010-04-02

Locations

21 sites across 11 countries: United States, Australia, Finland, Germany, Hungary, Italy, New Zealand, Poland, South Africa, Spain, United Kingdom

Source: ClinicalTrials.gov record NCT00519532. Inclusion in this directory is not an endorsement.