BibTex format
@article{Chaudhuri:2022:10.1186/s12883-022-02602-8,
author = {Chaudhuri, KR and Odin, P and Ferreira, JJ and Antonini, A and Rascol, O and Kurtis, MM and Storch, A and Bannister, K and Soares-da-Silva, P and Costa, R and Magalhães, D and Rocha, JF},
doi = {10.1186/s12883-022-02602-8},
journal = {BMC Neurology},
title = {Opicapone versus placebo in the treatment of Parkinson’s disease patients with end-of-dose motor fluctuation-associated pain: rationale and design of the randomised, double-blind OCEAN (OpiCapone Effect on motor fluctuations and pAiN) trial},
url = {http://dx.doi.org/10.1186/s12883-022-02602-8},
volume = {22},
year = {2022}
}
RIS format (EndNote, RefMan)
TY - JOUR
AB - <jats:title>Abstract</jats:title><jats:sec> <jats:title>Background</jats:title> <jats:p>Optimisation of dopaminergic therapy may alleviate fluctuation-related pain in Parkinson’s disease (PD). Opicapone (OPC) is a third-generation, once-daily catechol-O-methyltransferase inhibitor shown to be generally well tolerated and efficacious in reducing OFF-time in two pivotal trials in patients with PD and end-of-dose motor fluctuations. The OpiCapone Effect on motor fluctuations and pAiN (OCEAN) trial aims to investigate the efficacy of OPC 50 mg in PD patients with end-of-dose motor fluctuations and associated pain, when administered as adjunctive therapy to existing treatment with levodopa/dopa decarboxylase inhibitor (DDCi).</jats:p> </jats:sec><jats:sec> <jats:title>Methods</jats:title> <jats:p>OCEAN is a Phase IV, international, multicentre, randomised, double-blind, placebo-controlled, parallel-group, interventional trial in PD patients with end-of-dose motor fluctuations and associated pain. It consists of a 1-week screening period, 24-week double-blind treatment period and 2-week follow-up period. Eligible patients will be randomised 1:1 to OPC 50 mg or placebo once daily while continuing current treatment with levodopa/DDCi and other chronic, stable anti-PD and/or analgesic treatments. The primary efficacy endpoint is change from baseline in Domain 3 (fluctuation-related pain) of the King’s Parkinson’s disease Pain Scale (KPPS). The key secondary efficacy endpoint is change from baseline in Domain B (anxiety) of the Movement Disorder Society-sponsored Non-Motor rating Scale (MDS-NMS). Additional secondary efficacy assessments include other domains and total scores of the KPPS and MDS-NMS, the Parkinson’s Disease Questionnaire (PDQ-8), the MDS-sponsored Unified Parkinson’s Diseas
AU - Chaudhuri,KR
AU - Odin,P
AU - Ferreira,JJ
AU - Antonini,A
AU - Rascol,O
AU - Kurtis,MM
AU - Storch,A
AU - Bannister,K
AU - Soares-da-Silva,P
AU - Costa,R
AU - Magalhães,D
AU - Rocha,JF
DO - 10.1186/s12883-022-02602-8
PY - 2022///
TI - Opicapone versus placebo in the treatment of Parkinson’s disease patients with end-of-dose motor fluctuation-associated pain: rationale and design of the randomised, double-blind OCEAN (OpiCapone Effect on motor fluctuations and pAiN) trial
T2 - BMC Neurology
UR - http://dx.doi.org/10.1186/s12883-022-02602-8
UR - https://doi.org/10.1186/s12883-022-02602-8
VL - 22
ER -