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TUDCA-ALS SIGNED

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

Total Cost €

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EC-Contrib. €

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Partnership

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Outcomes and
results

TUDCA-ALS project word cloud

Explore the words cloud of the TUDCA-ALS project. It provides you a very rough idea of what is the project "TUDCA-ALS" about.

force tauroursodeoxycholic brainstem forced efforts administration sporadic proof life neurodegenerative therapy perform neurons rare neurofilament die secondary levels obtain therapeutic revised muscles positively functional 5d prove vital safety diagnosis csf invasive expert motor latter correlated mmp trial primary population function iib riluzole survival lateral mrc treatments international muscle treatment disorder ing atrophy deterioration tracheostomy grounded amyotrophic successful performed cord measured alsaq time als clinical patient biomarkers capacity biomarker combining cooperation expression corresponding ventilation eq skeletal questionnaire benefits serum tudca efficacy respiratory quality acid rating endpoints ambition sclerosis randomized modestly patients death progressive voluntary majority cognitive brain spinal weakness data involvement prevalence endpoint

Project "TUDCA-ALS" data sheet

The following table provides information about the project.

Coordinator	HUMANITAS MIRASOLE SPA Organization address address: VIA MANZONI 56 city: ROZZANO (MI) postcode: 20100 website: www.humanitas.it contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.
Coordinator Country	Italy [IT]
Project website	http://www.tudca.eu/
Total cost	5˙596˙928 €
EC max contribution	5˙596˙928 € (100%)
Programme	1. H2020-EU.3.1.3. (Treating and managing disease)
Code Call	H2020-SC1-2017-Two-Stage-RTD
Funding Scheme	RIA
Starting year	2018
Duration (year-month-day)	from 2018-01-01 to 2021-12-31

Partnership

Take a look of project's partnership.

#	participants	country	role	EC contrib. [€]
1	HUMANITAS MIRASOLE SPA HUMANITAS MIRASOLE SPA Organization address address: VIA MANZONI 56 city: ROZZANO (MI) postcode: 20100 website: www.humanitas.it contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	IT (ROZZANO (MI))	coordinator	1˙526˙994.00
2	THE UNIVERSITY OF SHEFFIELD THE UNIVERSITY OF SHEFFIELD Organization address address: FIRTH COURT WESTERN BANK city: SHEFFIELD postcode: S10 2TN website: www.shef.ac.uk contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	UK (SHEFFIELD)	participant	731˙906.00
3	UNIVERSITAIR MEDISCH CENTRUM UTRECHT UNIVERSITAIR MEDISCH CENTRUM UTRECHT Organization address address: HEIDELBERGLAAN 100 city: UTRECHT postcode: 3584 CX website: www.umcutrecht.nl contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	NL (UTRECHT)	participant	689˙197.00
4	UNIVERSITAET ULM UNIVERSITAET ULM Organization address address: HELMHOLTZSTRASSE 16 city: ULM postcode: 89081 website: www.uni-ulm.de contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	DE (ULM)	participant	647˙125.00
5	BRUSCHETTINI SRL BRUSCHETTINI SRL Organization address address: VIA ISONZO 6 city: GENOVA postcode: 16147 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	IT (GENOVA)	participant	516˙868.00
6	CENTRE HOSPITALIER REGIONAL UNIVERSITAIRE DE TOURS CENTRE HOSPITALIER REGIONAL UNIVERSITAIRE DE TOURS Organization address address: BOULEVARD TONELLE 2 city: TOURS CEDEX 9 postcode: 37044 website: www.chu-tours.fr contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	FR (TOURS CEDEX 9)	participant	490˙906.00
7	KATHOLIEKE UNIVERSITEIT LEUVEN KATHOLIEKE UNIVERSITEIT LEUVEN Organization address address: OUDE MARKT 13 city: LEUVEN postcode: 3000 website: www.kuleuven.be contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	BE (LEUVEN)	participant	352˙281.00
8	THE PROVOST, FELLOWS, FOUNDATION SCHOLARS & THE OTHER MEMBERS OF BOARD OF THE COLLEGE OF THE HOLY & UNDIVIDED TRINITY OF QUEEN ELIZABETH NEAR DUBLIN THE PROVOST, FELLOWS, FOUNDATION SCHOLARS & THE OTHER MEMBERS OF BOARD OF THE COLLEGE OF THE HOLY & UNDIVIDED TRINITY OF QUEEN ELIZABETH NEAR DUBLIN Organization address address: College Green city: DUBLIN postcode: 2 website: www.tcd.ie contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	IE (DUBLIN)	participant	351˙086.00
9	ISTITUTO SUPERIORE DI SANITA ISTITUTO SUPERIORE DI SANITA Organization address address: Viale Regina Elena 299 city: ROMA postcode: 161 website: http://www.iss.it contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	IT (ROMA)	participant	239˙375.00
10	MOTOR NEURONE DISEASE ASSOCIATION MOTOR NEURONE DISEASE ASSOCIATION Organization address address: 10 15 NOTRE DAME MEWS city: NORTHAMPTON postcode: NN1 2BG website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	UK (NORTHAMPTON)	participant	51˙187.00

Map

Project objective

TUDCA-ALS will focus on amyotrophic lateral sclerosis (ALS) a rare neurodegenerative disorder, that affects motor neurons in the brain, brainstem and spinal cord, resulting in progressive weakness and atrophy of voluntary skeletal muscles. ALS has an estimated prevalence of 5.40 cases per 100.000 population corresponding at about 40.000 patients at European level. Treatments are modestly effective at best, and the majority of patients die within 3-5 years of diagnosis, often from respiratory failure. TUDCA-ALS is based on the results of a successful proof-of-concept trial and has the ambition to develop a novel therapy in patients with ALS, based on administration of tauroursodeoxycholic acid (TUDCA) in addition to riluzole. TUDCA-ALS aims to perform a state-of-art randomized control trial on safety and efficacy of TUDCA in patients with sporadic ALS, without cognitive involvement and to exploit the project results into a novel therapeutic treatment for ALS. The trial primary endpoint is deterioration of function measured with the ALS Functional Rating Scale Revised. The secondary endpoints are: (1) Survival time to invasive ventilation (tracheostomy) or death; (2) changes in quality of life parameters measured by the ALSAQ-40 questionnaire; (3) functional changes measured by Forced Vital Capacity, and the EQ-5D scale. Muscle force will be assessed by the MRC scale and a correlated analysis of function and survival will be performed. Two biomarkers will be measured: neurofilament levels in the CSF and serum and MMP-9 expression in serum. The latter is a possible biomarker of TUDCA efficacy. TUDCA-ALS is grounded on promising phase IIb clinical data and is expected to impact positively on the international research efforts on ALS. TUDCA-ALS aims to obtain concrete benefits for patients with ALS. If the trial will prove successful, the consortium will support the development of this treatment at European level by combining expert knowledge and patient cooperation.

Deliverables

List of deliverables.
Dissemination and exploitation plan	Documents, reports	2020-02-13 12:58:06
Project website	Websites, patent fillings, videos etc.	2020-02-13 12:58:06

Take a look to the deliverables list in detail: detailed list of TUDCA-ALS deliverables.

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The information about "TUDCA-ALS" are provided by the European Opendata Portal: CORDIS opendata.

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