title: A Randomized Controlled Exploratory Pilot Study to Evaluate the Effect of Rotigotine Transdermal Patch on Parkinson's Disease-Associated Chronic Pain.
abstract: Pain is a troublesome nonmotor symptom of Parkinson's disease (PD). This double-blind exploratory pilot study (NCT01744496) was the first to specifically investigate the effect of a dopamine agonist on PD-associated pain as primary outcome. Patients with advanced PD (ie, receiving levodopa) and at least moderate PD-associated chronic pain (≥3 months, ≥4 points on 11-point Likert pain scale) were randomized to rotigotine (optimal/maximum dose ≤16 mg/24h) or placebo and maintained for 12 weeks. Primary efficacy variable was change in pain severity (Likert pain scale) from baseline to end of maintenance. Secondary variables included percentage of responders (≥2-point Likert pain scale reduction), King's PD Pain Scale (KPPS) domains, and PD Questionnaire (PDQ-8). Statistical analyses were exploratory. Of 68 randomized patients, 60 (rotigotine, 30; placebo, 30) were evaluable for efficacy. A numerical improvement in pain was observed in favor of rotigotine (Likert pain scale: least-squares mean [95%CI] treatment difference, -0.76 [-1.87 to 0.34]; P = .172), and proportion of responders was 18/30 (60%) rotigotine vs 14/30 (47%) placebo. An ∼2-fold numerical improvement in KPPS domain "fluctuation-related pain" was observed with rotigotine vs placebo. Rotigotine improved PDQ-8 vs placebo (-8.01 [-15.56 to -0.46]; P = .038). These results suggest rotigotine may improve PD-associated pain; a large-scale confirmatory study is needed.
authors.affiliation: Clinical Investigation Center CIC1436 and Department of Clinical Pharmacology and Neurosciences, INSERM, Toulouse University Hospital and University of Toulouse, Toulouse, France.
authors.forename: Olivier
authors.initials: O
authors.lastname: Rascol
authors.affiliation: University of South Florida Ataxia Research Center, The Frances J. Zesiewicz Foundation for Parkinson's Disease at USF, Parkinson's Disease and Movement Disorders Clinic at the PADREC, James A. Haley Veterans' Administration, Tampa, FL, USA.
authors.forename: Theresa
authors.initials: T
authors.lastname: Zesiewicz
authors.affiliation: National Parkinson's Foundation International Centre of Excellence, King's College Hospital, Kings College and Kings Health Partners, London, UK.
authors.forename: K Ray
authors.initials: KR
authors.lastname: Chaudhuri
authors.affiliation: UCB Pharma, Raleigh, NC, USA.
authors.forename: Mahnaz
authors.initials: M
authors.lastname: Asgharnejad
authors.affiliation: UCB Pharma, Monheim am Rhein, Germany.
authors.forename: Erwin
authors.initials: E
authors.lastname: Surmann
authors.affiliation: UCB Pharma, Brussels, Belgium.
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Dohin
authors.affiliation: UCB Pharma, Monheim am Rhein, Germany.
authors.forename: Sigrid
authors.initials: S
authors.lastname: Nilius
authors.affiliation: UCB Pharma, Monheim am Rhein, Germany.
authors.forename: Lars
authors.initials: L
authors.lastname: Bauer
mesh_terms: D000368:Aged; D059350:Chronic Pain / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology; D018491:Dopamine Agonists / Q000008:administration & dosage*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D038622:Internationality; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement / Q000187:drug effects / Q000379:methods; D010300:Parkinson Disease / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology; D010865:Pilot Projects; D011446:Prospective Studies; D013764:Tetrahydronaphthalenes / Q000008:administration & dosage*; D013876:Thiophenes / Q000008:administration & dosage*; D057968:Transdermal Patch; D016896:Treatment Outcome
chemical_list: D018491:Dopamine Agonists; D013764:Tetrahydronaphthalenes; D013876:Thiophenes; C047508:rotigotine
keywords: Parkinson's disease; dopamine receptor agonist; pain; pilot study; randomized controlled trial