2 research outputs found
Oxycodone or Higher Dose of Levodopa for the Treatment of Parkinsonian Central Pain: OXYDOPA Trial
International audienceBackground: 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 oxycodoneâ prolongedârelease (PR) and higher dose of levodopa/benserazide) compared with placebo in patients with PCP.Methods: OXYDOPA was a randomized, doubleâblind, doubleâdummy, placeboâcontrolled, multicenter parallelâgroup trial run at 15 centers within the French NSâPark network. PD patients with PCP (â„30 on the Visual Analogue Scale [VAS]) were randomly assigned to receive oxycodoneâPR (up to 40âmg/day), levodopa/benserazide (up to 200âmg/day) or matching placebo three times a day (tid) for 8âweeks at a stable dose, in addâon 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 weekâ10 based on modified intentionâtoâtreat analyses.Results: Between May 2016 and August 2020, 66 patients were randomized to oxycodoneâPR (nâ=â23), levodopa/benserazide (nâ=â20) or placebo (nâ=â23). The mean change in pain intensity was â17â±â18.5 on oxycodoneâPR, â8.3â±â11.1 on levodopa/benserazide, and â14.3â±â18.9 in the placebo groups. The absolute difference versus placebo was â1.54 (97.5% confidence interval [CI], â17.0 to 13.90; P =â0.8) on oxycodoneâPR and +7.79 (97.5% CI, â4.99 to 20.58; P =â0.2) on levodopa/benserazide. Similar proportions of patients in each group experienced allâcause adverse events. Those leading to study discontinuation were most frequently observed with oxycodoneâPR (39%) than levodopa/benserazide (5%) or placebo (15%).Conclusions: The present trial failed to demonstrate the superiority of oxycodoneâPR or a higher dose of levodopa in patients with PCP, while oxycodoneâPR was poorly tolerated. © 2024 The Author(s). Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society
Symptoms assessment and decision to treat patients with advanced Parkinsonâs disease based on wearables data
International audienceBody-worn sensors (BWS) could provide valuable information in the management of Parkinsonâs disease and support therapeutic decisions based on objective monitoring. To study this pivotal step and better understand how relevant information is extracted from BWS results and translated into treatment adaptation, eight neurologists examined eight virtual cases composed of basic patient profiles and their BWS monitoring results. Sixty-four interpretations of monitoring results and the subsequent therapeutic decisions were collected. Relationship between interrater agreements in the BWS reading and the severity of symptoms were analyzed via correlation studies. Logistic regression was used to identify associations between the BWS parameters and suggested treatment modifications. Interrater agreements were high and significantly associated with the BWS scores. Summarized BWS scores reflecting bradykinesia, dyskinesia, and tremor predicted the direction of treatment modifications. Our results suggest that monitoring information is robustly linked to treatment adaptation and pave the way to loop systems able to automatically propose treatment modifications from BWS recordings information