title: Rotigotine effects on early morning motor function and sleep in Parkinson's disease: a double-blind, randomized, placebo-controlled study (RECOVER).
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.
authors.affiliation: Department of Clinical Neurophysiology, University of Goettingen and Paracelsus-Elena Klinik, Kassel, Germany. ctrenkwalder@gmx.de
authors.forename: Claudia
authors.initials: C
authors.lastname: Trenkwalder
authors.forename: Bryan
authors.initials: B
authors.lastname: Kies
authors.forename: Monika
authors.initials: M
authors.lastname: Rudzinska
authors.forename: Jennifer
authors.initials: J
authors.lastname: Fine
authors.forename: Janos
authors.initials: J
authors.lastname: Nikl
authors.forename: Krystyna
authors.initials: K
authors.lastname: Honczarenko
authors.forename: Peter
authors.initials: P
authors.lastname: Dioszeghy
authors.forename: Dennis
authors.initials: D
authors.lastname: Hill
authors.forename: Tim
authors.initials: T
authors.lastname: Anderson
authors.forename: Vilho
authors.initials: V
authors.lastname: Myllyla
authors.forename: Jan
authors.initials: J
authors.lastname: Kassubek
authors.forename: Malcolm
authors.initials: M
authors.lastname: Steiger
authors.forename: Marco
authors.initials: M
authors.lastname: Zucconi
authors.forename: Eduardo
authors.initials: E
authors.lastname: Tolosa
authors.forename: Werner
authors.initials: W
authors.lastname: Poewe
authors.forename: Erwin
authors.initials: E
authors.lastname: Surmann
authors.forename: John
authors.initials: J
authors.lastname: Whitesides
authors.forename: Babak
authors.initials: B
authors.lastname: Boroojerdi
authors.forename: Kallol Ray
authors.initials: KR
authors.lastname: Chaudhuri
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018491:Dopamine Agonists / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009043:Motor Activity / Q000187:drug effects*; D010300:Parkinson Disease / Q000150:complications*; D012720:Severity of Illness Index; D012893:Sleep Wake Disorders / Q000188:drug therapy* / Q000209:etiology; D013764:Tetrahydronaphthalenes / Q000627:therapeutic use*; D013876:Thiophenes / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D018491:Dopamine Agonists; D013764:Tetrahydronaphthalenes; D013876:Thiophenes; C047508:rotigotine