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LIBRIS Formathandbok  (Information om MARC21)
FältnamnIndikatorerMetadata
00005470naa a2200529 4500
001oai:lup.lub.lu.se:d8b9b86e-3ad5-4b06-b26f-324999dcd748
003SwePub
008220608s2022 | |||||||||||000 ||eng|
0247 a https://lup.lub.lu.se/record/d8b9b86e-3ad5-4b06-b26f-324999dcd7482 URI
0247 a https://doi.org/10.1186/s12883-022-02602-82 DOI
040 a (SwePub)lu
041 a engb eng
042 9 SwePub
072 7a art2 swepub-publicationtype
072 7a ref2 swepub-contenttype
1001 a Chaudhuri, K. Rayu King's College Hospital4 aut
2451 0a 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
264 c 2022-03-12
264 1b Springer Science and Business Media LLC,c 2022
520 a 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.
650 7a MEDICIN OCH HÄLSOVETENSKAPx Medicinska och farmaceutiska grundvetenskaperx Farmakologi och toxikologi0 (SwePub)301022 hsv//swe
650 7a MEDICAL AND HEALTH SCIENCESx Basic Medicinex Pharmacology and Toxicology0 (SwePub)301022 hsv//eng
653 a Dopamine
653 a King’s Parkinson’s disease Pain Scale
653 a Levodopa
653 a Motor fluctuations
653 a Non-motor fluctuations
653 a Non-motor symptoms
653 a Opicapone
653 a Pain
653 a Parkinson’s disease
7001 a Odin, Peru Lund 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 Groups4 aut0 (Swepub:lu)med-poi
7001 a Ferreira, Joaquim J.u Portuguese National Programme for Respiratory Diseases (PNDR)4 aut
7001 a Antonini, Angelou University of Padova4 aut
7001 a Rascol, Olivieru Toulouse University Hospital4 aut
7001 a Kurtis, Mónica M.u Ruber Internacional Hospital4 aut
7001 a Storch, Alexanderu Universitätsmedizin Rostock4 aut
7001 a Bannister, Kirstyu King's College London4 aut
7001 a Soares-da-Silva, Patríciou Fundação Bial,University of Porto4 aut
7001 a Costa, Raquelu Fundação Bial4 aut
7001 a Magalhães, Diogou Fundação Bial4 aut
7001 a Rocha, José Franciscou Fundação Bial4 aut
7102 a King's College Hospitalb Neurologi, Lund4 org
7730 t BMC Neurologyd : Springer Science and Business Media LLCg 22:1q 22:1x 1471-2377
8564 u http://dx.doi.org/10.1186/s12883-022-02602-8x freey FULLTEXT
8564 8u https://lup.lub.lu.se/record/d8b9b86e-3ad5-4b06-b26f-324999dcd748
8564 8u https://doi.org/10.1186/s12883-022-02602-8

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