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dc.contributor.authorAlbanese, A
dc.contributor.authorLudolph, AC
dc.contributor.authorMcDermott, CJ
dc.contributor.authorCorcia, P
dc.contributor.authorVan Damme, P
dc.contributor.authorVan den Berg, LH
dc.contributor.authorHardiman, O
dc.contributor.authorRinaldi, G
dc.contributor.authorVanacore, N
dc.contributor.authorDickie, B
dc.date.accessioned2022-10-31T12:02:20Z
dc.date.issued2022-09-27
dc.identifier.issn1664-2295
dc.identifier.issn1664-2295
dc.identifier.other1009113
dc.identifier.urihttp://hdl.handle.net/10026.1/19786
dc.description.abstract

<jats:sec><jats:title>Background</jats:title><jats:p>Amyotrophic lateral sclerosis (ALS) is a chronic neurodegenerative rare disease that affects motor neurons in the brain, brainstem, and spinal cord, resulting in progressive weakness and atrophy of voluntary skeletal muscles. Although much has been achieved in understanding the disease pathogenesis, treatment options are limited, and in Europe, riluzole is the only approved drug. Recently, some other drugs showed minor effects.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>The TUDCA-ALS trial is a phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial. The study aims to enroll 320 patients in 25 centers across seven countries in Europe. Enrolled patients are randomized to one of two treatment arms: TUDCA or identical placebo by oral route. The study measures disease progression during the treatment period and compares it to natural progression during a no-treatment run-in phase. Clinical data and specific biomarkers are measured during the trial. The study is coordinated by a consortium composed of leading European ALS centers.</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>This trial is aimed to determine whether TUDCA has a disease-modifying activity in ALS. Demonstration of TUDCA efficacy, combined with the validation of new biomarkers, could advance ALS patient care.</jats:p></jats:sec><jats:sec><jats:title>Clinical trial registration</jats:title><jats:p><jats:ext-link>ClinicalTrials.gov</jats:ext-link>, identifier: NCT03800524.</jats:p></jats:sec>

dc.format.extent1009113-
dc.format.mediumElectronic-eCollection
dc.languageeng
dc.language.isoeng
dc.publisherFrontiers Media
dc.subjectamyotrophic lateral sclerosis
dc.subjectbile acids
dc.subjectclinical trial
dc.subjectphase III
dc.subjecttherapy
dc.titleTauroursodeoxycholic acid in patients with amyotrophic lateral sclerosis: The TUDCA-ALS trial protocol
dc.typejournal-article
dc.typeJournal Article
plymouth.author-urlhttps://www.ncbi.nlm.nih.gov/pubmed/36237618
plymouth.volume13
plymouth.publisher-urlhttp://dx.doi.org/10.3389/fneur.2022.1009113
plymouth.publication-statusPublished online
plymouth.journalFrontiers in Neurology
dc.identifier.doi10.3389/fneur.2022.1009113
plymouth.organisational-group/Plymouth
plymouth.organisational-group/Plymouth/Faculty of Health
plymouth.organisational-group/Plymouth/Faculty of Health/Peninsula Medical School
plymouth.organisational-group/Plymouth/REF 2021 Researchers by UoA
plymouth.organisational-group/Plymouth/REF 2021 Researchers by UoA/UoA01 Clinical Medicine
plymouth.organisational-group/Plymouth/Research Groups
plymouth.organisational-group/Plymouth/Research Groups/Institute of Translational and Stratified Medicine (ITSMED)
plymouth.organisational-group/Plymouth/Research Groups/Institute of Translational and Stratified Medicine (ITSMED)/CBR
plymouth.organisational-group/Plymouth/Users by role
plymouth.organisational-group/Plymouth/Users by role/Academics
plymouth.organisational-group/Plymouth/Users by role/Researchers in ResearchFish submission
dc.publisher.placeSwitzerland
dcterms.dateAccepted2022-09-05
dc.rights.embargodate2022-11-1
dc.identifier.eissn1664-2295
dc.rights.embargoperiodNot known
rioxxterms.versionofrecord10.3389/fneur.2022.1009113
rioxxterms.licenseref.urihttp://www.rioxx.net/licenses/all-rights-reserved
rioxxterms.licenseref.startdate2022
rioxxterms.typeJournal Article/Review


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