Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
184 participants
INTERVENTIONAL
2021-10-25
2025-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Active treatment
Tauroursodeoxycholic Acid
Tauroursodeoxycholic acid (TUDCA) 250 mg capsules Doses: 4 capsules (1 g) twice daily 10-15 minutes after a meal Mode of administration: orally Duration: 18 months
Interventions
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Tauroursodeoxycholic Acid
Tauroursodeoxycholic acid (TUDCA) 250 mg capsules Doses: 4 capsules (1 g) twice daily 10-15 minutes after a meal Mode of administration: orally Duration: 18 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Signed informed consent for participation in the TUDCA-ALS Extension sub-study
Exclusion Criteria
* Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive TUDCA or that the subject is unable or unlikely to comply with the dosing schedule or study evaluations
* The patient of reproductive potential is sexually active and is not willing to use highly effective contraception during the study and up to 90 days after the day of last dose
* The patient is pregnant or breast feeding
18 Years
ALL
No
Sponsors
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University of Ulm
OTHER
University of Sheffield
OTHER
University Hospital, Tours
OTHER
KU Leuven
OTHER
UMC Utrecht
OTHER
University of Dublin, Trinity College
OTHER
Bruschettini S.r.l.
UNKNOWN
Istituto Superiore di Sanità
OTHER
Motor Neurone Disease Association
UNKNOWN
Humanitas Mirasole SpA
OTHER
Responsible Party
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Locations
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Katholieke Universiteit Leuven
Leuven, , Belgium
Centre Hospitalier Universitaire de Bordeaux
Bordeaux, , France
Centre Hospitalier Universitaire Limoges
Limoges, , France
Centre Hospitalier Universitaire de Montpellier
Montpellier, , France
Centre Hospitalier Regional Universitaire de Tours
Tours, , France
Charité - Universitätsmedizin Berlin
Berlin, , Germany
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Universitätsklinikum Jena
Jena, , Germany
Universität Ulm
Ulm, , Germany
Trinity College Dublin
Dublin, , Ireland
IRCCS Istituto Auxologico Italiano
Milan, , Italy
NEuroMuscular Omnicentre. Fondazione Serena Onlus
Milan, , Italy
AOU Università degli Studi della Campania "Luigi Vanvitelli"
Napoli, , Italy
IRCCS Istituto Clinico Humanitas
Rozzano, , Italy
Azienda Ospedaliera Santa Maria di Terni
Terni, , Italy
AOU Città della Salute e della Scienza di Torino
Torino, , Italy
Universitair Medisch Centrum Utrecht
Utrecht, , Netherlands
The Walton Centre NHS Foundation Trust
Liverpool, , United Kingdom
Plymouth Hospitals NHS Trust
Plymouth, , United Kingdom
Salford Royal NHS Foundation Trust
Salford, , United Kingdom
University of Sheffield
Sheffield, , United Kingdom
Royal Stoke University Hospital
Stoke, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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H2020/755094/2017/OLE
Identifier Type: -
Identifier Source: org_study_id
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