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

This study has been terminated.
(Due to clinical trial supplies shortage)
Sponsor:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00519532
First received: August 21, 2007
Last updated: August 30, 2011
Last verified: September 2010

August 21, 2007
August 30, 2011
July 2007
May 2009   (final data collection date for primary outcome measure)
  • Change From Baseline in UPDRS III Score at Week 13 (End of Maintenance) [ Time Frame: Baseline (baseline SP915) and week 13 (End of maintenance) ] [ Designated as safety issue: No ]

    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) ] [ Designated as safety issue: No ]

    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.

Change in motor function, sleep quality and non-motor symptoms over the course of the trial [ Time Frame: baseline to end of maintenance ]
Complete list of historical versions of study NCT00519532 on ClinicalTrials.gov Archive Site
  • 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) ] [ Designated as safety issue: No ]

    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) ] [ Designated as safety issue: No ]

    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.

Change in Pain; Depression; Safety variables [ Time Frame: baseline to end of maintenance ]
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Parkinson's Disease
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®
Experimental: Rotigotine
Rotigotine Transdermal Patch
Intervention: Drug: Rotigotine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
84
May 2009
May 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Completion of trial SP889

Exclusion Criteria:

  • Ongoing serious adverse event assessed as related to trial medication
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany,   United States,   Australia,   Finland,   United Kingdom,   Hungary,   Italy,   New Zealand,   Poland,   South Africa,   Spain
 
NCT00519532
SP915, EudraCT number: 2006-006907-35
No
UCB Pharma
UCB Pharma
Not Provided
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
UCB Pharma
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP