Safety and efficacy of tauroursodeoxycholic acid (TUDCA) as add-on treatment in patients affected by amyotrophic lateral sclerosis (ALS)

Informations projet

TUDCA-ALS

N° de convention de subvention: 755094

DOI

10.3030/755094

Projet clôturé

Date de signature de la CE 15 Novembre 2017

Date de début 1 Janvier 2018

Date de fin 31 Decembre 2023

Financé au titre de

• SOCIETAL CHALLENGES - Health, demographic change and well-being

Coût total

€ 5 596 928,00

Contribution de l’UE

€ 5 596 928,00

Coordonné par

HUMANITAS MIRASOLE SPA
Italy

CORDIS fournit des liens vers les livrables publics et les publications des projets HORIZON.

Les liens vers les livrables et les publications des projets du 7e PC, ainsi que les liens vers certains types de résultats spécifiques tels que les jeux de données et les logiciels, sont récupérés dynamiquement sur OpenAIRE .

Livrables

Open Research Data Pilot (1)

Report on status of posting results in the study registry

Report on status of posting results in the study registry. The report will include the status of the result posting as well as the timelines when final posting of results is scheduled at end of funding period (Month 72)

Documents, reports (4)

Dissemination and exploitation plan

Dissemination and Exploitation Plan. The document will describe the dissemination and exploitation strategies and action plan (Month 3

Statistical analysis of primary and secondary outcome variables

Statistical analysis of primary and secondary outcome variables. (Month 72) This report will include the statistical analysis on primary and secondaty outcome variables

Demographic and clinical description of the study population

This report will include study population data on demographic and clinical aspects

Statistical analysis of biomarker and correlation with clinical outcomes

Statistical analysis of biomarker and correlation with clinical outcomes. (Month 66) This report will include data on statistical analysis of biomarkers and related correlation to clinical outcomes.

Websites, patent fillings, videos etc. (1)

Project website

Project website. The report will include the characteristics of the website, the activities involved for its creation and print screens of the website pages (Month 6

Publications

Peer reviewed articles (6)

Review of disease-modifying drug trials in amyotrophic lateral sclerosis

Auteurs: Paolo Tornese; Stefania Lalli; Antoniangela Cocco; Alberto Albanese
Publié dans: Journal of Neurology Neurosurgery and Psychiatry, Numéro 3, 2022, Page(s) 521-529, ISSN 0022-3050
Éditeur: BMJ Publishing Group
DOI: 10.1136/jnnp-2021-328470

Tauro-Urso-Deoxycholic Acid Trials in Amyotrophic Lateral Sclerosis: What is Achieved and What to Expect

Auteurs: Maria Lo Giudice, Antoniangela Cocco, Giorgio Reggiardo, Stefania Lalli, Alberto Albanese
Publié dans: Clinical Drug Investigation, 2023, ISSN 1179-1918
Éditeur: Springer
DOI: 10.1007/s40261-023-01324-0

Tauroursodeoxycholic acid: a potential therapeutic tool in neurodegenerative diseases

Auteurs: Kareem Khalaf; Paolo Tornese; Antoniangela Cocco; Alberto Albanese
Publié dans: Translational Neurodegeneration, Numéro 3, 2022, Page(s) 33, ISSN 2047-9158
Éditeur: Springer Nature
DOI: 10.1186/s40035-022-00307-z

A randomized double-blind clinical trial on safety and efficacy of tauroursodeoxycholic acid (TUDCA) as add-on treatment in patients affected by amyotrophic lateral sclerosis (ALS): the statistical analysis plan of TUDCA-ALS trial

Auteurs: Flavia L Lombardo, Stefania Spila Alegiani, Flavia Mayer, Marta Cipriani, Maria Lo Giudice, Albert Christian Ludolph, Christopher J McDermott, Philippe Corcia, Philip Van Damme, Leonard H Van den Berg, Orla Hardiman, Gabriele Nicolini, Nicola Vanacore, Brian Dickie, Alberto Albanese, Maria Puopolo; TUDCA-ALS Study Group (Paolo Tornese, Antoniangela Cocco, Michela Matteoli, Eliana Lauranzano, Maria
Publié dans: Trials, 2023, ISSN 1745-6215
Éditeur: BioMed Central
DOI: 10.1186/s13063-023-07638-w

Cox regression and survival analysis from the tauro-urso-deoxycholic trial in amyotrophic lateral sclerosis

Auteurs: Giorgio Reggiardo; Maria Lo Giudice; Stefania Lalli; Gilberto Rinaldi; Alberto Albanese
Publié dans: Frontiers in Neurology, Numéro 5, 2023, ISSN 1664-2295
Éditeur: Frontiers Research Foundation
DOI: 10.3389/fneur.2023.1163855

Tauroursodeoxycholic acid in patients with amyotrophic lateral sclerosis: The TUDCA-ALS trial protocol

Auteurs: Alberto Albanese, Albert Christian Ludolph, Christopher J McDermott, Philippe Corcia, Philip Van Damme, Leonard H Van den Berg, Orla Hardiman, Gilberto Rinaldi, Nicola Vanacore, Brian Dickie, TUDCA-ALS Study Group (Tornese Paolo, Cocco Antoniangela, Lo Giudice Maria, Matteoli Michela, Lauranzano Eliana, Malosio Maria Luisa, Adriana Elia Chiara, Lombardo Flavia, Mayer Flavia, Puopolo Maria, Alegian
Publié dans: Frontiers in Neurology, Numéro 16642295, 2022, ISSN 1664-2295
Éditeur: Frontiers Research Foundation
DOI: 10.3389/fneur.2022.1009113