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Article Dans Une Revue Movement Disorders Année : 2024

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

1 CIC 1436 - Centre d'investigation clinique de Toulouse
2 ToNIC - Toulouse NeuroImaging Center
3 CHU Toulouse - Centre Hospitalier Universitaire de Toulouse
4 Service de Neurologie [CHU Clermont-Ferrand]
5 IP - Institut Pascal
6 LilNCog - Lille Neurosciences & Cognition - U 1172
7 CHRU Lille - Centre Hospitalier Régional Universitaire [CHU Lille]
8 Département Neurologie [CHU Toulouse]
9 Service de neurologie [Rouen]
10 NorDic - Neuroendocrine, Endocrine and Germinal Differentiation Communication
11 CHU Nantes - Centre Hospitalier Universitaire de Nantes = Nantes University Hospital
12 Plateforme F-CRIN
13 Centre Hospitalier Universitaire de Rennes [CHU Rennes] = Rennes University Hospital [Pontchaillou]
14 CIC - Centre d'Investigation Clinique [Rennes]
15 Service de neurologie [Amiens]
16 LNFP - Laboratoire de Neurosciences Fonctionnelles et Pathologies - UR UPJV 4559
17 Service d'Electroneuromyographie et Service de Neurologie C [Hôpital Pierre Wertheimer - HCL]
18 ISC-MJ - Institut des sciences cognitives Marc Jeannerod - Centre de neuroscience cognitive - UMR5229
19 Hôpital Henri Mondor
20 IMRB - Institut Mondor de Recherche Biomédicale
21 ICM - Institut du Cerveau = Paris Brain Institute
22 CIC Neurosciences - Centre d'investigation clinique Neurosciences [CHU Pitié Salpêtrière]
23 CHU Nîmes - Hôpital Universitaire Carémeau [Nîmes]
24 FMTS - Fédération de Médecine Translationnelle de Strasbourg
25 UNISTRA - Université de Strasbourg
26 HUS - Les Hôpitaux Universitaires de Strasbourg
27 TIMONE - Hôpital de la Timone [CHU - APHM]
28 INT - Institut de Neurosciences de la Timone
29 CHRU Nancy - Centre Hospitalier Régional Universitaire de Nancy
30 CIC 1402 - CIC Poitiers – Centre d'investigation clinique de Poitiers
31 CHU de Poitiers [La Milétrie] - Centre hospitalier universitaire de Poitiers = Poitiers University Hospital

Résumé

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.

Domaines

Neurosciences

Dates et versions

hal-04606320 , version 1 (10-06-2024)

Identifiants

Citer

Christine Brefel-Courbon, Estelle Harroch, Ana Marques, David Devos, Claire Thalamas, et al.. Oxycodone or Higher Dose of Levodopa for the Treatment of Parkinsonian Central Pain: OXYDOPA Trial. Movement Disorders, 2024, Online ahead of print. ⟨10.1002/mds.29878⟩. ⟨hal-04606320⟩
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