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

Tracking Information
First Submitted Date ICMJE	August 21, 2007
First Posted Date ICMJE	August 22, 2007
Results First Submitted Date	March 17, 2010
Results First Posted Date	April 2, 2010
Last Update Posted Date	October 27, 2014
Study Start Date ICMJE	July 2007
Actual Primary Completion Date	May 2009 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: April 6, 2010)	Change From Baseline in UPDRS III Score at Week 13 (End of Maintenance) [ Time Frame: Baseline (baseline SP915) and week 13 (End of maintenance) ]The Unified Parkinson´s Disease Rating Scale Part III is an accepted and validated scale for the assessment of motor function in Parkinson´s disease. Each of the elements in the UPDRS III is measured on a scale of 0 to 4, where 0 is normal and 4 represents severe abnormalities. Baseline is defined as first titration visit (T1) of SP915.; Change From Baseline in Parkinson Disease Sleep Scale (PDSS) at Week 13 (End of Maintenance) [ Time Frame: Baseline (baseline SP889 NCT00474058) and week 13 (End of maintenance) ]The Parkinson Disease Sleep Scale (PDSS) is a questionnaire with 15 questions to assess sleep and nocturnal disability in Parkinson´s disease. The item- scores range between 0= never and 4= very often. Baseline is defined as Visit 2 of previous double- blind trial SP889.
Original Primary Outcome Measures ICMJE; (submitted: August 21, 2007)	Change in motor function, sleep quality and non-motor symptoms over the course of the trial [ Time Frame: baseline to end of maintenance ]
Change History	Complete list of historical versions of study NCT00519532 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: April 6, 2010)	Change From Baseline in Nocturnal Akinesia, Dystonia, and Cramps Score (NADCS) at Week 13 (End of Maintenance) [ Time Frame: Baseline (baseline SP889 NCT00474058) and week 13 (End of maintenance) ]Subjects were asked to assess nocturnal akinesia, dystonia and cramps, using an ordinal severity scale. While a score of 0= normal and 4= maximal severity, subjects could also rate their symptoms with values of 0.5, 1.5, 2.5, 3.5. The nocturnal akinesia score was used to evaluate motor performance while the dystonia and cramps scores were used to evaluate sleep. Baseline is defined as Visit 2 of previous double- blind trial SP889.; Change From Baseline in Number of Nocturias at Week 13 (End of Maintenance) [ Time Frame: Baseline (baseline SP889 NCT00474058) and week 13 (End of maintenance) ]The change in number of nocturias was used to evaluate improvements in sleep disorders. Baseline is defined as Visit 2 of previous double- blind trial SP889.
Original Secondary Outcome Measures ICMJE; (submitted: August 21, 2007)	Change in Pain; Depression; Safety variables [ Time Frame: baseline to end of maintenance ]
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Long-term Extension of RECOVER- Long-term Effect of the 24h Transdermal Delivery of Rotigotine in Subjects With Idiopathic Parkinson's Disease
Official Title ICMJE	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
Brief 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.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Parkinson's Disease
Intervention ICMJE	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 Name: Neupro®
Study Arms	Experimental: Rotigotine; Rotigotine Transdermal Patch; Intervention: Drug: Rotigotine
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Terminated
Actual Enrollment ICMJE; (submitted: May 7, 2009)	84
Original Estimated Enrollment ICMJE; (submitted: August 21, 2007)	270
Actual Study Completion Date	May 2009
Actual Primary Completion Date	May 2009 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Completion of trial SP889 Exclusion Criteria: Ongoing serious adverse event assessed as related to trial medication
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Australia, Finland, Germany, Hungary, Italy, New Zealand, Poland, South Africa, Spain, United Kingdom, United States
Removed Location Countries	Austria
Administrative Information
NCT Number ICMJE	NCT00519532
Other Study ID Numbers ICMJE	SP0915; EudraCT number: 2006-006907-35 ( Other Identifier: EudraCT )
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	UCB Pharma
Study Sponsor ICMJE	UCB Pharma
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
PRS Account	UCB Pharma
Verification Date	September 2010
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP