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Opicapone versus pl...
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Chaudhuri, K. RayKing's College Hospital
(author)
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
- Article/chapterEnglish2022
Publisher, publication year, extent ...
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2022-03-12
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Springer Science and Business Media LLC,2022
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LIBRIS-ID:oai:lup.lub.lu.se:d8b9b86e-3ad5-4b06-b26f-324999dcd748
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https://lup.lub.lu.se/record/d8b9b86e-3ad5-4b06-b26f-324999dcd748URI
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https://doi.org/10.1186/s12883-022-02602-8DOI
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Language:English
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Summary in:English
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Subject category:art swepub-publicationtype
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Background: 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). Methods: 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 Disease Rating Scale (MDS-UPDRS) Parts III and IV, Clinical and Patient’s Global Impressions of Change, and change in functional status via Hauser’s diary. Safety assessments include the incidence of treatment-emergent adverse events. The study will be conducted in approximately 140 patients from 50 clinical sites in Germany, Italy, Portugal, Spain and the United Kingdom. Recruitment started in February 2021 and the last patient is expected to complete the study by late 2022. Discussion: The OCEAN trial will help determine whether the use of adjunctive OPC 50 mg treatment can improve fluctuation-associated pain in PD patients with end-of-dose motor fluctuations. The robust design of OCEAN will address the current lack of reliable evidence for dopaminergic-based therapy in the treatment of PD-associated pain. Trial registration: EudraCT number 2020–001175-32; registered on 2020-08-07.
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Odin, PerLund University,Lunds universitet,Neurologi, Lund,Sektion IV,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Restorative Parkinson Unit,Forskargrupper vid Lunds universitet,Neurology, Lund,Section IV,Department of Clinical Sciences, Lund,Faculty of Medicine,Lund University Research Groups(Swepub:lu)med-poi
(author)
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Ferreira, Joaquim J.Portuguese National Programme for Respiratory Diseases (PNDR)
(author)
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Antonini, AngeloUniversity of Padova
(author)
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Rascol, OlivierToulouse University Hospital
(author)
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Kurtis, Mónica M.Ruber Internacional Hospital
(author)
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Storch, AlexanderUniversitätsmedizin Rostock
(author)
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Bannister, KirstyKing's College London
(author)
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Soares-da-Silva, PatrícioFundação Bial,University of Porto
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Costa, RaquelFundação Bial
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Magalhães, DiogoFundação Bial
(author)
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Rocha, José FranciscoFundação Bial
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King's College HospitalNeurologi, Lund
(creator_code:org_t)
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In:BMC Neurology: Springer Science and Business Media LLC22:11471-2377
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