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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:
ClinicalTrials.gov Identifier:
NCT00519532
First Posted: August 22, 2007
Last Update Posted: October 27, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
UCB Pharma
  Purpose
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.

Condition Intervention Phase
Parkinson's Disease Drug: Rotigotine Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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.



Enrollment: 84
Study Start Date: July 2007
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rotigotine
Rotigotine Transdermal Patch
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®

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Completion of trial SP889

Exclusion Criteria:

  • Ongoing serious adverse event assessed as related to trial medication
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00519532


Locations
United States, Florida
St. Petersburg, Florida, United States, 33701
United States, North Carolina
Salisbury, North Carolina, United States, 28144
Australia
Concord, Australia
Finland
Oulu, Finland, 90220
Germany
Berlin, Germany, 10713
Dresden, Germany, 01307
Kassel, Germany, 34128
Marburg, Germany, 35039
Naumburg, Germany, 06618
Ulm, Germany, 89081
Hungary
Budapest, Hungary, 1145
Nyiregyhaza, Hungary, 4400
Italy
Chieti, Italy
Milano, Italy, 20127
New Zealand
Christchurch, New Zealand
Poland
Olyszytn, Poland
South Africa
Cape Town, South Africa
Spain
Barcelona, Spain
Madrid, Spain
United Kingdom
Lancashire, United Kingdom
Liverpool, United Kingdom, L9 7JL
Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

Additional Information:
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00519532     History of Changes
Other Study ID Numbers: SP0915
EudraCT number: 2006-006907-35 ( Other Identifier: EudraCT )
First Submitted: August 21, 2007
First Posted: August 22, 2007
Results First Submitted: March 17, 2010
Results First Posted: April 2, 2010
Last Update Posted: October 27, 2014
Last Verified: September 2010

Keywords provided by UCB Pharma:
Neupro®
Rotigotine
Parkinson's Disease

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Rotigotine
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs