Oxycodone or Higher Dose of Levodopa for the Treatment of Parkinsonian Central Pain: OXYDOPA Trial.

Autor: Brefel-Courbon C; 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.; Toulouse Neuroimaging Centre (TONIC), UMR1214 INSERM/UT3, Toulouse, France., Harroch E; 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., Marques A; Department of Neurology, CHU Clermont-Ferrand, Université Clermont-Auvergne, CNRS, IGCCN, Institut Pascal, NS-PARK/FCRIN Network, Aubière, France., Devos D; 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., Thalamas C; Department of Clinical Pharmacology, Methodology Data management and Statistical Analysis Unit, Centre d'Investigation Clinique CIC1436, University Hospital of Toulouse, Toulouse, France., Rousseau V; Department of Clinical Pharmacology, Methodology Data management and Statistical Analysis Unit, Centre d'Investigation Clinique CIC1436, University Hospital of Toulouse, Toulouse, France., Ory-Magne F; 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., Fabbri M; 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., Maltête D; Department of Neurology, Rouen University Hospital and University of Rouen, Mont-Saint-Aignan, France.; INSERM U1239, Laboratory of Neuronal and Neuroendocrine Differentiation and Communication, NS-PARK/FCRIN Network, Mont-Saint-Aignan, France., Rouaud T; Department of Neurology, Nantes University Hospital, NS-PARK/FCRIN Network, Nantes, France., Drapier S; Department of Neurology, Rennes University Hospital, CIC INSERM 1414, NS-PARK/FCRIN Network, Rennes, France., Tir M; 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., Thobois S; Univ Lyon, Université Claude Bernard Lyon 1, Faculté de Médecine Lyon Sud Charles Mérieux, CNRS, Institut des Sciences Cognitives, UMR 5229, Bron, France.; Centre Expert Parkinson, Hôpital Neurologique 'Pierre Wertheimer', Hospices Civils de Lyon, NS-PARK/FCRIN Network, Lyon, France., Salhi H; 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., Corvol JC; 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., Castelnovo G; Department of Neurology, CHU Nîmes, Hôpital Caremeau, Nimes, France., Lagha-Boukbiza O; Service de Neurologie, Hôpitaux Universitaires de Strasbourg, Strasbourg, France.; Fédération de Médecine Translationnelle de Strasbourg (FMTS), Université de Strasbourg, NS-PARK/FCRIN Network, Strasbourg, France., Fluchère F; Service de Neurologie et Pathologie du Mouvement, Aix Marseille Université, AP-HM, Hôpital de La Timone, and UMR CNRS, Marseille, France., Frismand S; Neurology Department, Nancy University Hospital, Nancy, France., Ansquer S; Service de Neurologie, Centre Expert Parkinson, CIC-INSERM 1402, CHU Poitiers, NS-PARK/FCRIN Network, Poitiers, France., Sommet A; Department of Clinical Pharmacology, Methodology Data management and Statistical Analysis Unit, Centre d'Investigation Clinique CIC1436, University Hospital of Toulouse, Toulouse, France., Rascol O; 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.; Toulouse Neuroimaging Centre (TONIC), UMR1214 INSERM/UT3, Toulouse, France.
Jazyk: angličtina
Zdroj: Movement disorders : official journal of the Movement Disorder Society [Mov Disord] 2024 Sep; Vol. 39 (9), pp. 1533-1543. Date of Electronic Publication: 2024 Jun 08.
DOI: 10.1002/mds.29878
Abstrakt: Background: Among the different types of pain related to Parkinson's disease (PD), parkinsonian central pain (PCP) is the most disabling.
Objectives: We 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.
Methods: OXYDOPA 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.
Results: Between 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%).
Conclusions: The 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.
(© 2024 The Author(s). Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.)
Databáze: MEDLINE
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