title: Rotigotine vs ropinirole in advanced stage Parkinson's disease: a double-blind study.
abstract: OBJECTIVE
  To confirm the superiority of transdermal rotigotine up to 16 mg/24 h over placebo, and non-inferiority to ropinirole, in Japanese Parkinson's disease (PD) patients on concomitant levodopa therapy.
  
  
  METHODS
  This trial was a randomized, double-blind, double-dummy, three-arm parallel group placebo- and ropinirole-controlled trial. Four-hundred and twenty PD patients whose motor symptoms were not well controlled by levodopa treatment were randomized 2:2:1 to receive rotigotine, ropinirole (up to 15 mg/day) or placebo during a 16-week treatment period followed by a 4-week taper period. The primary variable was change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III (ON state) sum score from baseline to the end of the treatment period.
  
  
  RESULTS
  The difference in the change in the UPDRS Part III (ON state) sum score from baseline to the end of treatment between rotigotine and placebo groups was -6.4 ± 1.2 (95% CI: -8.7 to -4.1; p < 0.001), indicating superiority of rotigotine over placebo. The difference between rotigotine and ropinirole groups was -1.4 ± 1.0 (95% CI: -3.2 to 0.5), below the non-inferiority margin, indicating the non-inferiority of rotigotine to ropinirole. Application site reaction was seen in 57.7% of the patients in the rotigotine group and in 18.6% in the ropinirole group (P < 0.001). No other safety issue was noted.
  
  
  CONCLUSIONS
  Rotigotine was well tolerated at doses up to 16 mg/24 h and showed similar efficacy to ropinirole except that the application site reaction was much higher in the rotigotine group.
authors.affiliation: Department of Neurology, Juntendo University School of Medicine, Tokyo, Japan. Electronic address: y_mizuno@juntendo.ac.jp.
authors.forename: Yoshikuni
authors.initials: Y
authors.lastname: Mizuno
authors.affiliation: Department of Neurology, Ehime University School of Medicine, Matsuyama, Japan.
authors.forename: Masahiro
authors.initials: M
authors.lastname: Nomoto
authors.affiliation: Department of Neurology, National Hospital Organization, Sagamihara National Hospital, Sagamihara, Japan.
authors.forename: Kazuko
authors.initials: K
authors.lastname: Hasegawa
authors.affiliation: Department of Neurology, Juntendo University School of Medicine, Tokyo, Japan.
authors.forename: Nobutaka
authors.initials: N
authors.lastname: Hattori
authors.affiliation: Department of Neurology, Juntendo University School of Medicine, Tokyo, Japan.
authors.forename: Tomoyoshi
authors.initials: T
authors.lastname: Kondo
authors.affiliation: Department of Neurology, National Center Hospital, National Center of Neurology and Psychiatry, Tokyo, Japan.
authors.forename: Miho
authors.initials: M
authors.lastname: Murata
authors.affiliation: Department of Biostatistics, Kitasato University School of Pharmacy, Tokyo, Japan.
authors.forename: Masahiro
authors.initials: M
authors.lastname: Takeuchi
authors.affiliation: Department of Clinical Research and Development, Otsuka Pharmaceutical Co., Ltd., Tokyo, Japan.
authors.forename: Masayoshi
authors.initials: M
authors.lastname: Takahashi
authors.affiliation: Department of Clinical Research and Development, Otsuka Pharmaceutical Co., Ltd., Tokyo, Japan.
authors.forename: Takayuki
authors.initials: T
authors.lastname: Tomida
mesh_terms: D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D000978:Antiparkinson Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007211:Indoles / Q000627:therapeutic use*; D007564:Japan; D007980:Levodopa / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D010300:Parkinson Disease / Q000188:drug therapy*; D012720:Severity of Illness Index; D013764:Tetrahydronaphthalenes / Q000627:therapeutic use*; D013876:Thiophenes / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000978:Antiparkinson Agents; D007211:Indoles; D013764:Tetrahydronaphthalenes; D013876:Thiophenes; C046649:ropinirole; D007980:Levodopa; C047508:rotigotine
keywords: Parkinson's disease; Randomized trial; Ropinirole; Rotigotine; Treatment