%0 Journal Article
%T Oxycodone or Higher Dose of Levodopa for the Treatment of Parkinsonian Central Pain: OXYDOPA Trial.
%A Brefel-Courbon C
%A Harroch E
%A Marques A
%A Devos D
%A Thalamas C
%A Rousseau V
%A Ory-Magne F
%A Fabbri M
%A Maltête D
%A Rouaud T
%A Drapier S
%A Tir M
%A Thobois S
%A Salhi H
%A Corvol JC
%A Castelnovo G
%A Lagha-Boukbiza O
%A Fluchère F
%A Frismand S
%A Ansquer S
%A Sommet A
%A Rascol O
%J Mov Disord
%V 0
%N 0
%D 2024 Jun 8
%M 38850081
%F 9.698
%R 10.1002/mds.29878
%X <B>BACKGROUND: </B>Among the different types of pain related to Parkinson's disease (PD), parkinsonian central pain (PCP) is the most disabling.<BR><B>OBJECTIVE: </B>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.<BR><B>METHODS: </B>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.<BR><B>RESULTS: </B>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%).<BR><B>CONCLUSIONS: </B>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.