Randomized Evaluation of the 24-Hour Coverage: Efficacy of Rotigotine
NCT ID: NCT00474058
Last Updated: 2015-06-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
287 participants
INTERVENTIONAL
2007-05-31
2009-03-31
Brief Summary
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Detailed Description
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After a Screening Period of up to 28 days subjects will be hospitalized for two nights. After the second overnight stay, subjects will be randomly assigned either to rotigotine patch or placebo patch. Afterwards patients will be titrated to their optimal dose. After subjects have reached their optimal dose (or the highest dose) they will be maintained on this dose for a certain period. At the end of maintenance the subjects will be hospitalized for two nights. Afterwards the doses will be continuously decreased.
Efficacy will be assessed by application of sleep quality scores, motor examination scores, and scores to evaluate non-motor symptoms of Parkinsons. Safety assessments include adverse events, 12-lead electrocardiograms, blood pressure and heart rate assessments, and laboratory checks.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Rotigotine
Rotigotine transdermal patch
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
Placebo
Placebo transdermal patch
Placebo
Placebo transdermal patches
Interventions
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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
Placebo
Placebo transdermal patches
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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UCB Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Clinical Trial Call Center
Role: STUDY_DIRECTOR
+1 877 822 9493 (UCB)
Locations
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Reseda, California, United States
Ventura, California, United States
St. Petersburg, Florida, United States
Salisbury, North Carolina, United States
Winston_Salem, North Carolina, United States
Warwick, Rhode Island, United States
Houston, Texas, United States
Concord, New South Wales, Australia
Adelaide, South Australia, Australia
Fitzroy, , Australia
Innsbruck, , Austria
Hyvinkää, , Finland
Oulu, , Finland
Berlin, , Germany
Berlin, , Germany
Dresden, , Germany
Kassel, , Germany
Leipzig, , Germany
Marburg, , Germany
Naumburg, , Germany
Ulm, , Germany
Budapest, , Hungary
Debrecen, , Hungary
Nyíregyháza, , Hungary
Zalaegerszeg, , Hungary
Chieti, , Italy
Milan, , Italy
Torino, , Italy
Christchurch, , New Zealand
Wellington, , New Zealand
Gdansk, , Poland
Krakow, , Poland
Lublin, , Poland
Olsztyn, , Poland
Szczecin, , Poland
Warsaw, , Poland
Cape Town, , South Africa
Capetown, , South Africa
Johannesburg, , South Africa
Pretoria/Gauteng, , South Africa
Tygerberg, , South Africa
Barcelona, , Spain
Madrid, , Spain
Bristol, , United Kingdom
Lancashire, , United Kingdom
Liverpool, , United Kingdom
London, , United Kingdom
Countries
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References
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Ghys L, Surmann E, Whitesides J, Boroojerdi B. Effect of rotigotine on sleep and quality of life in Parkinson's disease patients: post hoc analysis of RECOVER patients who were symptomatic at baseline. Expert Opin Pharmacother. 2011 Sep;12(13):1985-98. doi: 10.1517/14656566.2011.604031. Epub 2011 Jul 27.
Kassubek J, Chaudhuri KR, Zesiewicz T, Surmann E, Boroojerdi B, Moran K, Ghys L, Trenkwalder C. Rotigotine transdermal system and evaluation of pain in patients with Parkinson's disease: a post hoc analysis of the RECOVER study. BMC Neurol. 2014 Mar 6;14:42. doi: 10.1186/1471-2377-14-42.
Swick TJ, Friedman JH, Chaudhuri KR, Surmann E, Boroojerdi B, Moran K, Ghys L, Trenkwalder C. Associations between severity of motor function and nonmotor symptoms in Parkinson's disease: a post hoc analysis of the RECOVER Study. Eur Neurol. 2014;71(3-4):140-7. doi: 10.1159/000355019. Epub 2014 Jan 21.
Trenkwalder C, Kies B, Rudzinska M, Fine J, Nikl J, Honczarenko K, Dioszeghy P, Hill D, Anderson T, Myllyla V, Kassubek J, Steiger M, Zucconi M, Tolosa E, Poewe W, Surmann E, Whitesides J, Boroojerdi B, Chaudhuri KR; Recover Study Group. Rotigotine effects on early morning motor function and sleep in Parkinson's disease: a double-blind, randomized, placebo-controlled study (RECOVER). Mov Disord. 2011 Jan;26(1):90-9. doi: 10.1002/mds.23441. Epub 2010 Nov 18.
Related Links
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FDA Safety Alerts and Recalls
Other Identifiers
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EudraCT No.: 2006-006752-35
Identifier Type: OTHER
Identifier Source: secondary_id
SP0889
Identifier Type: -
Identifier Source: org_study_id
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