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UNKNOWNPhase 3NCT05753852

Open Label Extension of TUDCA-ALS Study

This study will provide extended access to patients and assess longer-term outcomes on patients who have completed the TUDCA-ALS study.

Lead sponsor: Humanitas Mirasole SpA•23 locations•View source on ClinicalTrials.gov

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Contacts

Alberto Albanese, MD

CONTACT

+39-0282246418 alberto.albanese@humanitas.it

Sponsors

Lead Sponsor

Humanitas Mirasole SpA

Collaborators

University of Ulm
University of Sheffield
University Hospital, Tours
KU Leuven
UMC Utrecht
University of Dublin, Trinity College
Bruschettini S.r.l.
Istituto Superiore di Sanità
Motor Neurone Disease Association

The TUDCA-ALS Open label extension study is designed to investigate long term safety, tolerability and efficacy of tauroursodeoxycholic acid in patients with ALS who completed the TUDCA-ALS study

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Completion of the visit M18 (Month 18) of the TUDCA-ALS clinical trial.
•Signed informed consent for participation in the TUDCA-ALS Extension sub-study

Exclusion Criteria

•Treatment with edaravone or other unaccepted concomitant therapy
•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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: March 3, 2023Terms

Trial snapshot

StatusUNKNOWN

PhasePHASE3

Enrollment184

Start dateOct 2021

Last updatedMar 3, 2023

Condition

Amyotrophic Lateral Sclerosis

Locations shown

Katholieke Universiteit Leuven

Leuven

Centre Hospitalier Universitaire de Bordeaux

Bordeaux

Centre Hospitalier Universitaire Limoges

Limoges

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 3, 2023Data synced to Clareo: July 13, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions