Oxycodone or Higher Dose of Levodopa for the Treatment of Parkinsonian Central Pain: OXYDOPA Trial.
Oxycodone or Higher Dose of Levodopa for the Treatment of Parkinsonian Central Pain: OXYDOPA Trial.
Where did the research take place?
The study site has not been established. Author addresses may differ from where the research occurred.
Toulouse, FR · Author affiliation
Department of Clinical Pharmacology and Neurosciences, Parkinson Expert Centre, Centre d'Investigation Clinique CIC1436, University Hospital of Toulouse, NeuroToul COEN Centre, NS-PARK/FCRIN Network, Toulouse, France.Location evidence
Clermont-Ferrand, FR · Author affiliation
Department of Neurology, CHU Clermont-Ferrand, Université Clermont-Auvergne, CNRS, IGCCN, Institut Pascal, NS-PARK/FCRIN Network, Aubière, France.Location evidence
Lille, FR · Author affiliation
Department of Medical Pharmacology, Expert Centre of Parkinson's Disease, University of Lille, LilNCog, Lille Neuroscience and Cognition, Inserm, INSERM UMR-S1172, CHU de Lille LICEND COEN Center Lille NS-Park Network, Lille, France.Location evidence
Rouen, FR · Author affiliation
Department of Neurology, Rouen University Hospital and University of Rouen, Mont-Saint-Aignan, France.Location evidence
Mont-Saint-Aignan, FR · Author affiliation
Department of Neurology, Rouen University Hospital and University of Rouen, Mont-Saint-Aignan, France.Location evidence
Nantes, FR · Author affiliation
Department of Neurology, Nantes University Hospital, NS-PARK/FCRIN Network, Nantes, France.Location evidence
Rennes, FR · Author affiliation
Department of Neurology, Rennes University Hospital, CIC INSERM 1414, NS-PARK/FCRIN Network, Rennes, France.Location evidence
Amiens, FR · Author affiliation
Department of Neurology, Department of Neurosurgery, Expert Centre for Parkinson's Disease, Amiens University Hospital, EA 4559 Laboratoire de Neurosciences Fonctionnelles et Pathologie (LNFP) Université de Picardie Jules Verne, University of Picardy Jules Verne (UPJV), NS-PARK/FCRIN Network, Amiens, France.Location evidence
Lyon, FR · Author affiliation
Univ Lyon, Université Claude Bernard Lyon 1, Faculté de Médecine Lyon Sud Charles Mérieux, CNRS, Institut des Sciences Cognitives, UMR 5229, Bron, France.Location evidence
Bron, FR · Author affiliation
Univ Lyon, Université Claude Bernard Lyon 1, Faculté de Médecine Lyon Sud Charles Mérieux, CNRS, Institut des Sciences Cognitives, UMR 5229, Bron, France.Location evidence
Créteil, FR · Author affiliation
Centre Expert Parkinson, Neurologie, and Equipe 01 NPI IMRB; CHU Henri Mondor, AP-HP, INSERM et Faculté de Santé, Université Paris-Est Créteil, Créteil, France.Location evidence
Paris, FR · Author affiliation
Département de Neurologie, CIC Neurosciences, Sorbonne Université, Assistance Publique Hôpitaux de Paris, Paris Brain Institute (ICM), Inserm, CNRS, Hôpital Pitié-Salpêtrière, NS-PARK/FCRIN Network, Paris, France.Location evidence
Nîmes, FR · Author affiliation
Department of Neurology, CHU Nîmes, Hôpital Caremeau, Nimes, France.Location evidence
Strasbourg, FR · Author affiliation
Service de Neurologie, Hôpitaux Universitaires de Strasbourg, Strasbourg, France.Location evidence
Marseille, FR · Author affiliation
Service de Neurologie et Pathologie du Mouvement, Aix Marseille Université, AP-HM, Hôpital de La Timone, and UMR CNRS, Marseille, France.Location evidence
Nancy, FR · Author affiliation
Neurology Department, Nancy University Hospital, Nancy, France.Location evidence
Poitiers, FR · Author affiliation
Service de Neurologie, Centre Expert Parkinson, CIC-INSERM 1402, CHU Poitiers, NS-PARK/FCRIN Network, Poitiers, France.Location evidence
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Original abstract
BackgroundAmong the different types of pain related to Parkinson's disease (PD), parkinsonian central pain (PCP) is the most disabling.ObjectivesWe investigated the analgesic efficacy of two therapeutic strategies (opioid with oxycodone- prolonged-release (PR) and higher dose of levodopa/benserazide) compared with placebo in patients with PCP.MethodsOXYDOPA was a randomized, double-blind, double-dummy, placebo-controlled, multicenter parallel-group trial run at 15 centers within the French NS-Park network. PD patients with PCP (≥30 on the Visual Analogue Scale [VAS]) were randomly assigned to receive oxycodone-PR (up to 40 mg/day), levodopa/benserazide (up to 200 mg/day) or matching placebo three times a day (tid) for 8 weeks at a stable dose, in add-on to their current dopaminergic therapy. The primary endpoint was the change in average pain intensity over the previous week rated on VAS from baseline to week-10 based on modified intention-to-treat analyses.ResultsBetween May 2016 and August 2020, 66 patients were randomized to oxycodone-PR (n = 23), levodopa/benserazide (n = 20) or placebo (n = 23). The mean change in pain intensity was -17 ± 18.5 on oxycodone-PR, -8.3 ± 11.1 on levodopa/benserazide, and -14.3 ± 18.9 in the placebo groups. The absolute difference versus placebo was -1.54 (97.5% confidence interval [CI], -17.0 to 13.90; P = 0.8) on oxycodone-PR and +7.79 (97.5% CI, -4.99 to 20.58; P = 0.2) on levodopa/benserazide. Similar proportions of patients in each group experienced all-cause adverse events. Those leading to study discontinuation were most frequently observed with oxycodone-PR (39%) than levodopa/benserazide (5%) or placebo (15%).ConclusionsThe present trial failed to demonstrate the superiority of oxycodone-PR or a higher dose of levodopa in patients with PCP, while oxycodone-PR was poorly tolerated. © 2024 The Author(s). Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.