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: Olivier Rascol, Theresa Zesiewicz, K Ray Chaudhuri, Mahnaz Asgharnejad, Erwin Surmann, Elisabeth Dohin, Sigrid Nilius, Lars Bauer
• Journal: Journal of clinical pharmacology (J Clin Pharmacol) Vol. 56 Issue 7 Pg. 852-61 (07 2016) ISSN: 1552-4604 [Electronic] England
• PMID: 26626320 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: © 2015, The American College of Clinical Pharmacology.

Chemical References

• Dopamine Agonists
• Tetrahydronaphthalenes
• Thiophenes
• rotigotine

Topics

• Aged
• Chronic Pain (diagnosis, drug therapy, epidemiology)
• Dopamine Agonists (administration & dosage)
• Double-Blind Method
• Female
• Humans
• Internationality
• Male
• Middle Aged
• Pain Measurement (drug effects, methods)
• Parkinson Disease (diagnosis, drug therapy, epidemiology)
• Pilot Projects
• Prospective Studies
• Tetrahydronaphthalenes (administration & dosage)
• Thiophenes (administration & dosage)
• Transdermal Patch
• Treatment Outcome