Safety and Efficacy of TUDCA as add-on Treatment in Patients Affected by ALS
NCT ID: NCT03800524
Last Updated: 2023-07-10
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
337 participants
INTERVENTIONAL
2019-02-22
2023-12-31
Brief Summary
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Detailed Description
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TUDCA will be administered orally at the dose of 1 g twice daily (2 g daily) for 18 months. Patients will be taking also riluzole at the dose of 50 mg twice daily (100 mg daily).
Patient randomization will take place after a screening (lead-in) period of 12 weeks (3 months) with 3 assessments at 6-week intervals. Clinical assessments during the trial phase will be performed every three months. This will allow measuring the progression rate before and after starting treatment (either active or placebo).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Tauroursodeoxycholic acid (TUDCA)
* 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
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
Reference therapy
* Placebo capsules identical to active compound
* Doses: 4 capsules (1 g) twice daily 10-15 minutes after a meal
* Mode of administration: orally
* Duration: 18 months
Placebo
* Placebo 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
Placebo
* Placebo 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
* Disease duration ≤ 18 months at screening visit (month -3)
* Able to perform reproducible pulmonary function tests at screening visit (month -3)
* Forced vital capacity or slow vital capacity ≥70% of normal at screening visit (month -3)
* Stable on riluzole treatment for 3 months in the lead-in period
* Signed informed consent at screening visit (month -3)
Exclusion Criteria
* Other causes of neuromuscular weakness
* Presence of other neurodegenerative diseases
* Significant cognitive impairment, clinical dementia or psychiatric illness
* Severe cardiac or pulmonary disease
* Other diseases precluding functional assessments
* Other life-threatening diseases
* Any use of non-invasive ventilation (e.g. continuous positive airway pressure, non-invasive bi-level positive airway pressure or non-invasive volume ventilation) for any portion of the day, or mechanical ventilation via tracheostomy, or on any form of oxygen supplementation
* Gastrointestinal disorder that is likely to impair absorption of study drug from the gastrointestinal tract
* Has taken any investigational study drug within 30 days or five half-lives of the prior agent, whichever is longer, prior to dosing
* Any clinically significant laboratory abnormality
* Other concurrent investigational medications
* Active peptic ulcer
* Previous surgery or infections of small intestine
* Patients unable to easily swallow the treatment pills
* Acute inflammation of the gallbladder or bile ducts
* Occurrence of frequent biliary colic, biliary infections, severe pancreatic abnormalities
* Bile duct obstruction, calcified X-ray opaque gallstones and reduced mobility of the gallbladder
* Subjects who weigh 88 lbs (40 kg) or less
* Aspartate aminotransferase or alanine aminotransferase concentrations more than 3 times the upper limit of normal
* Creatinine clearance 50 ml/min or less
* Any clinically significant neurological, haematological, autoimmune, endocrine, cardiovascular, neoplastic, renal, gastrointestinal, or other disorder that, in the Investigator's opinion, could interfere with the subject's participation in the study, place the subject at increased risk, or confound interpretation of study results
* 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
80 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
European Commission
OTHER
Humanitas Mirasole SpA
OTHER
Responsible Party
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Principal Investigators
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Alberto Albanese, MD
Role: STUDY_CHAIR
Humanitas Mirasole SpA
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
Alfried Krupp Krankenhaus Rüttenscheid
Essen, , 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
Lancashire Teaching Hospitals NHS Foundation Trust
Preston, , 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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References
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Albanese A, Ludolph AC, McDermott CJ, Corcia P, Van Damme P, Van den Berg LH, Hardiman O, Rinaldi G, Vanacore N, Dickie B; TUDCA-ALS Study Group. Tauroursodeoxycholic acid in patients with amyotrophic lateral sclerosis: The TUDCA-ALS trial protocol. Front Neurol. 2022 Sep 27;13:1009113. doi: 10.3389/fneur.2022.1009113. eCollection 2022.
Lombardo FL, Spila Alegiani S, Mayer F, Cipriani M, Lo Giudice M, Ludolph AC, McDermott CJ, Corcia P, Van Damme P, Van den Berg LH, Hardiman O, Nicolini G, Vanacore N, Dickie B, Albanese A, Puopolo M; TUDCA-ALS Study Group. 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. Trials. 2023 Dec 5;24(1):792. doi: 10.1186/s13063-023-07638-w.
Related Links
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TUDCA-ALS Consortium website
Other Identifiers
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2018-002722-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
755094
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
H2020/755094/2017/IT-01
Identifier Type: -
Identifier Source: org_study_id
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