title: High doses of rotigotine transdermal patch: results of an open-label, dose-escalation trial in patients with advanced-stage, idiopathic Parkinson disease.
abstract: OBJECTIVE
  The objective of the study was to determine the maximal achievable dose of rotigotine by assessing the tolerability of escalating doses of rotigotine transdermal patch in patients with advanced-stage Parkinson disease.
  
  
  METHODS
  Thirty-four patients aged 30 years or older on a stable dose of l-dopa with an off time of at least 2.5 h/d were randomized to 2-titration schemes. The patients started on a dosage of 4 mg/24 h and received an incremental dosage of 4 mg/24 h per week in the fast-titration group and 2 mg/24 h per week in the slow-titration group to the maximal target dosage of 24 mg/24 h (patch size of 120 cm(2)). Thereafter, both groups entered a maintenance period of 42 days or longer for the rapid-titration group and 7 days or longer for the slow titration group followed by a 2-week safety follow-up period with stepwise dosage de-escalation of 4 mg/24 h for 4 days.
  
  
  RESULTS
  Twenty-seven patients completed the trial, of whom 24 completed without dose reduction. Twenty-six patients (76%) were titrated to the maximum target dose and thus had a maximal achievable dosage of at least 24 mg/24 h. Adverse events, generally mild or moderate, included application site reaction (12%), nausea, dyskinesia, and visual hallucinations (9% each). The mean time spent off decreased by 2 to 3 h/d. Duration of on without dyskinesia periods increased (2 h/d). The mean total (SD) Unified Parkinson's Disease Rating Score decreased by 18.9 (14.2) in the fast-titration group and 17.8 (14.0) in the slow titration group. A shift from off to on without dyskinesias in status after waking up was observed.
  
  
  CONCLUSIONS
  Rotigotine transdermal patch, up to 24 mg/24 h, was effective and well tolerated by patients with advanced-stage Parkinson disease.
authors: First Department of Neurology, Masaryk University, Saint Anne's Hospital, Brno, Czech Republic. irektor@med.muni.cz
authors: Ivan
authors: I
authors: Rektor
authors: Tomislav
authors: T
authors: Babic
authors: Bernard
authors: B
authors: Boothmann
authors: Jiri
authors: J
authors: Polivka
authors: Babak
authors: B
authors: Boroojerdi
authors: Olaf
authors: O
authors: Randerath
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D000368:Aged; D018491:Dopamine Agonists / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D018476:Hypokinesia / Q000188:drug therapy / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D010300:Parkinson Disease / Q000188:drug therapy* / Q000503:physiopathology; D010352:Patient Dropouts; D012720:Severity of Illness Index; D013764:Tetrahydronaphthalenes / Q000008:administration & dosage*; D013876:Thiophenes / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D018491:Dopamine Agonists; D013764:Tetrahydronaphthalenes; D013876:Thiophenes; C047508:rotigotine