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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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 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.

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

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
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surname: n.a.
function: n.a.
email: n.a.
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 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 IT (ROZZANO (MI)) coordinator 1˙526˙994.00
2    THE UNIVERSITY OF SHEFFIELD UK (SHEFFIELD) participant 731˙906.00
3    UNIVERSITAIR MEDISCH CENTRUM UTRECHT NL (UTRECHT) participant 689˙197.00
4    UNIVERSITAET ULM DE (ULM) participant 647˙125.00
5    BRUSCHETTINI SRL IT (GENOVA) participant 516˙868.00
6    CENTRE HOSPITALIER REGIONAL UNIVERSITAIRE DE TOURS FR (TOURS CEDEX 9) participant 490˙906.00
7    KATHOLIEKE UNIVERSITEIT LEUVEN 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 IE (DUBLIN) participant 351˙086.00
9    ISTITUTO SUPERIORE DI SANITA IT (ROMA) participant 239˙375.00
10    MOTOR NEURONE DISEASE ASSOCIATION 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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