Tauroursodeoxycholic acid in patients with amyotrophic lateral sclerosis: The TUDCA-ALS trial protocol
dc.contributor.author | Albanese, A | |
dc.contributor.author | Ludolph, AC | |
dc.contributor.author | McDermott, CJ | |
dc.contributor.author | Corcia, P | |
dc.contributor.author | Van Damme, P | |
dc.contributor.author | Van den Berg, LH | |
dc.contributor.author | Hardiman, O | |
dc.contributor.author | Rinaldi, G | |
dc.contributor.author | Vanacore, N | |
dc.contributor.author | Dickie, B | |
dc.date.accessioned | 2022-10-31T12:02:20Z | |
dc.date.issued | 2022-09-27 | |
dc.identifier.issn | 1664-2295 | |
dc.identifier.issn | 1664-2295 | |
dc.identifier.other | 1009113 | |
dc.identifier.uri | http://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.extent | 1009113- | |
dc.format.medium | Electronic-eCollection | |
dc.language | eng | |
dc.language.iso | eng | |
dc.publisher | Frontiers Media | |
dc.subject | amyotrophic lateral sclerosis | |
dc.subject | bile acids | |
dc.subject | clinical trial | |
dc.subject | phase III | |
dc.subject | therapy | |
dc.title | Tauroursodeoxycholic acid in patients with amyotrophic lateral sclerosis: The TUDCA-ALS trial protocol | |
dc.type | journal-article | |
dc.type | Journal Article | |
plymouth.author-url | https://www.ncbi.nlm.nih.gov/pubmed/36237618 | |
plymouth.volume | 13 | |
plymouth.publication-status | Published online | |
plymouth.journal | Frontiers in Neurology | |
dc.identifier.doi | 10.3389/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.place | Switzerland | |
dcterms.dateAccepted | 2022-09-05 | |
dc.rights.embargodate | 2022-11-1 | |
dc.identifier.eissn | 1664-2295 | |
dc.rights.embargoperiod | Not known | |
rioxxterms.versionofrecord | 10.3389/fneur.2022.1009113 | |
rioxxterms.licenseref.uri | http://www.rioxx.net/licenses/all-rights-reserved | |
rioxxterms.licenseref.startdate | 2022 | |
rioxxterms.type | Journal Article/Review |