Long-term Extension of RECOVER- Long-term Effect of the 24h Transdermal Delivery of Rotigotine in Subjects With Idiopathic Parkinson's Disease
NCT00519532 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 84
Last updated 2014-10-27
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
- 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
Sponsors & Collaborators
-
UCB Pharma
lead INDUSTRY
Principal Investigators
-
UCB Clinical Trial Call Center · +1 877 822 9493 (UCB)
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-07-31
- Primary Completion
- 2009-05-31
- Completion
- 2009-05-31
Countries
- United States
- Australia
- Finland
- Germany
- Hungary
- Italy
- New Zealand
- Poland
- South Africa
- Spain
- United Kingdom
Study Locations
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