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Rotigotine effects on early morning motor function and sleep in Parkinson's disease: A double-blind, randomized, placebo-controlled study (RECOVER)
Movement disorders, 2011-01, Vol.26 (1), p.90-99
Trenkwalder, Claudia
Kies, Bryan
Rudzinska, Monika
Fine, Jennifer
Nikl, Janos
Honczarenko, Krystyna
Dioszeghy, Peter
Hill, Dennis
Anderson, Tim
Myllyla, Vilho
Kassubek, Jan
Steiger, Malcolm
Zucconi, Marco
Tolosa, Eduardo
Poewe, Werner
Surmann, Erwin
Whitesides, John
Boroojerdi, Babak
Chaudhuri, Kallol Ray
the RECOVER Study Group
2011
Details
Autor(en) / Beteiligte
Trenkwalder, Claudia
Kies, Bryan
Rudzinska, Monika
Fine, Jennifer
Nikl, Janos
Honczarenko, Krystyna
Dioszeghy, Peter
Hill, Dennis
Anderson, Tim
Myllyla, Vilho
Kassubek, Jan
Steiger, Malcolm
Zucconi, Marco
Tolosa, Eduardo
Poewe, Werner
Surmann, Erwin
Whitesides, John
Boroojerdi, Babak
Chaudhuri, Kallol Ray
the RECOVER Study Group
Titel
Rotigotine effects on early morning motor function and sleep in Parkinson's disease: A double-blind, randomized, placebo-controlled study (RECOVER)
Ist Teil von
Movement disorders, 2011-01, Vol.26 (1), p.90-99
Ort / Verlag
Hoboken: Wiley Subscription Services, Inc., A Wiley Company
Erscheinungsjahr
2011
Link zum Volltext
Quelle
Wiley Online Library - AutoHoldings Journals
Beschreibungen/Notizen
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
Sprache
Englisch
Identifikatoren
ISSN: 0885-3185
eISSN: 1531-8257
DOI: 10.1002/mds.23441
Titel-ID: cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_3072524
Format
–
Schlagworte
Adult
,
Aged
,
Aged, 80 and over
,
Biological and medical sciences
,
Degenerative and inherited degenerative diseases of the nervous system. Leukodystrophies. Prion diseases
,
dopamine agonist
,
Dopamine Agonists - therapeutic use
,
Dose-Response Relationship, Drug
,
Double-Blind Method
,
Female
,
Follow-Up Studies
,
Humans
,
Male
,
Medical sciences
,
Middle Aged
,
Motor Activity - drug effects
,
motor function
,
Neurology
,
Parkinson Disease - complications
,
quality of life
,
rotigotine
,
Severity of Illness Index
,
sleep
,
Sleep Wake Disorders - drug therapy
,
Sleep Wake Disorders - etiology
,
Tetrahydronaphthalenes - therapeutic use
,
Thiophenes - therapeutic use
,
transdermal
,
Treatment Outcome
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