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Randomized Controlled Trial
. 2011 Jan;26(1):90-9.
doi: 10.1002/mds.23441. Epub 2010 Nov 18.

Rotigotine effects on early morning motor function and sleep in Parkinson's disease: a double-blind, randomized, placebo-controlled study (RECOVER)

Claudia Trenkwalder  1 , Bryan Kies, Monika Rudzinska, Jennifer Fine, Janos Nikl, Krystyna Honczarenko, Peter Dioszeghy, Dennis Hill, Tim Anderson, Vilho Myllyla, Jan Kassubek, Malcolm Steiger, Marco Zucconi, Eduardo Tolosa, Werner Poewe, Erwin Surmann, John Whitesides, Babak Boroojerdi, Kallol Ray Chaudhuri; Recover Study Group
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Free PMC article
Randomized Controlled Trial

Rotigotine effects on early morning motor function and sleep in Parkinson's disease: a double-blind, randomized, placebo-controlled study (RECOVER)

Claudia Trenkwalder et al. Mov Disord. 2011 Jan.
Free PMC article

Abstract

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.

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Figures

FIG. 1
FIG. 1
Modified Parkinson's Disease Sleep Scale (PDSS-2). ©Trenkwalder and Chaudhuri, 2010.
FIG. 2
FIG. 2
Subject disposition.
FIG. 3
FIG. 3
Mean change from baseline to end of maintenance in (A) UPDRS Part III scores and PDSS-2 total scores and (B) PDSS-2 domain and individual item LS mean rotigotine-placebo treatment differences (FAS-LOCF).
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