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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Rotigotine effects on early morning motor function and sleep in Parkinson's disease: A double-blind, randomized, placebo-controlled study (RECOVER)
Movement Disorders, Volume 26, No. 1, Year 2011
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Description
In a multinational, double-blind, placebo-controlled trial (NCT00474058), 287 subjects with Parkinson's disease (PD) and unsatisfactory early-morning motor symptom control were randomized 2:1 to receive rotigotine (2-16 mg/24 hr [n = 190]) or placebo (n = 97). Treatment was titrated to optimal dose over 1-8 weeks with subsequent dose maintenance for 4 weeks. Early-morning motor function and nocturnal sleep disturbance were assessed as coprimary efficacy endpoints using the Unified Parkinson's Disease Rating Scale (UPDRS) Part III (Motor Examination) measured in the early morning prior to any medication intake and the modified Parkinson's Disease Sleep Scale (PDSS-2) (mean change from baseline to end of maintenance [EOM], last observation carried forward). At EOM, mean UPDRS Part III score had decreased by -7.0 points with rotigotine (from a baseline of 29.6 [standard deviation (SD) 12.3] and by -3.9 points with placebo (baseline 32.0 [13.3]). Mean PDSS-2 total score had decreased by -5.9 points with rotigotine (from a baseline of 19.3 [SD 9.3]) and by -1.9 points with placebo (baseline 20.5 [10.4]). This represented a significantly greater improvement with rotigotine compared with placebo on both the UPDRS Part III (treatment difference: -3.55 [95% confidence interval (CI) -5.37, -1.73]; P = 0.0002) and PDSS-2 (treatment difference: -4.26 [95% CI -6.08, -2.45]; P < 0.0001). The most frequently reported adverse events were nausea (placebo, 9%; rotigotine, 21%), application site reactions (placebo, 4%; rotigotine, 15%), and dizziness (placebo, 6%; rotigotine 10%). Twenty-four-hour transdermal delivery of rotigotine to PD patients with early-morning motor dysfunction resulted in significant benefits in control of both motor function and nocturnal sleep disturbances. © 2010 Movement Disorder Society.
Available Materials
https://efashare.b-cdn.net/share/pmc/articles/PMC3072524/bin/mds0026-0090-SD1.doc
Authors & Co-Authors
Trenkwalder, Claudia
Germany, Gottingen
Georg-august-universität Göttingen
Kies, Bryan M.
South Africa, Cape Town
University of Cape Town
Rudzińska-Bar, Monika
Poland, Krakow
Jagiellonian University Medical College
Fine, Jennifer
South Africa, Cape Town
Constantiaberg Medi-clinic
Nikl, János
Hungary, Zalaegerszeg
Hospital of Zala County
Honczarenko, Krystyna
Poland, Szczecin
Pomeranian Medical University in Szczecin
Diószeghy, Péter
Hungary, Nyiregyhaza
County Hospital
Hill, Dennis
United States, Salisbury
Central Carolina Neurology and Sleep
Anderson, Tim J.
New Zealand, Christchurch
University of Otago, Christchurch
Myllylä, Vilho V.
Finland, Oulu
Oulu University Hospital
Kassubek, Jan
Germany, Ulm
Universität Ulm
Steiger, Malcolm
United Kingdom, Liverpool
The Walton Centre
Zucconi, Marco
Italy, Milan
Irccs Ospedale San Raffaele
Tolosa, Eduardo S.
Spain, Barcelona
Universitat de Barcelona
Poewe, Werner
Austria, Innsbruck
Medizinische Universitat Innsbruck
Surmann, Erwin
Belgium, Braine-l'alleud
Ucb S.a.
Whitesides, John
Belgium, Braine-l'alleud
Ucb S.a.
Boroojerdi, Babak
Belgium, Braine-l'alleud
Ucb S.a.
Ray Chaudhuri, K.
United Kingdom, London
King's College Hospital
Statistics
Citations: 399
Authors: 19
Affiliations: 17
Identifiers
Doi:
10.1002/mds.23441
ISSN:
08853185
e-ISSN:
15318257
Research Areas
Disability