Open Label Extension of TUDCA-ALS Study

Last updated: February 23, 2023
Sponsor: Humanitas Mirasole SpA
Overall Status: Active - Recruiting

Phase

3

Condition

Amyotrophic Lateral Sclerosis (Als)

Myasthenia Gravis (Chronic Weakness)

Treatment

N/A

Clinical Study ID

NCT05753852
H2020/755094/2017/OLE
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Treatment with edaravone or other unaccepted concomitant therapy
  • Consideration by the investigator, for any reason, that the subject is an unsuitablecandidate to receive TUDCA or that the subject is unable or unlikely to comply withthe dosing schedule or study evaluations
  • The patient of reproductive potential is sexually active and is not willing to usehighly effective contraception during the study and up to 90 days after the day oflast dose
  • The patient is pregnant or breast feeding

Study Design

Total Participants: 184
Study Start date:
October 25, 2021
Estimated Completion Date:
March 31, 2025

Study Description

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

Connect with a study center

  • Katholieke Universiteit Leuven

    Leuven,
    Belgium

    Site Not Available

  • Centre Hospitalier Universitaire de Bordeaux

    Bordeaux,
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire Limoges

    Limoges,
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Montpellier

    Montpellier,
    France

    Active - Recruiting

  • Centre Hospitalier Regional Universitaire de Tours

    Tours,
    France

    Active - Recruiting

  • Charité - Universitätsmedizin Berlin

    Berlin,
    Germany

    Active - Recruiting

  • Universitätsklinikum Carl Gustav Carus Dresden

    Dresden,
    Germany

    Active - Recruiting

  • Medizinische Hochschule Hannover

    Hannover,
    Germany

    Site Not Available

  • Universitätsklinikum Jena

    Jena,
    Germany

    Active - Recruiting

  • Universität Ulm

    Ulm,
    Germany

    Site Not Available

  • Trinity College Dublin

    Dublin,
    Ireland

    Site Not Available

  • IRCCS Istituto Auxologico Italiano

    Milano,
    Italy

    Active - Recruiting

  • NEuroMuscular Omnicentre. Fondazione Serena Onlus

    Milano,
    Italy

    Active - Recruiting

  • AOU Università degli Studi della Campania "Luigi Vanvitelli"

    Napoli,
    Italy

    Active - Recruiting

  • IRCCS Istituto Clinico Humanitas

    Rozzano,
    Italy

    Site Not Available

  • Azienda Ospedaliera Santa Maria di Terni

    Terni,
    Italy

    Active - Recruiting

  • AOU Città della Salute e della Scienza di Torino

    Torino,
    Italy

    Site Not Available

  • Universitair Medisch Centrum Utrecht

    Utrecht,
    Netherlands

    Site Not Available

  • The Walton Centre NHS Foundation Trust

    Liverpool,
    United Kingdom

    Site Not Available

  • Plymouth Hospitals NHS Trust

    Plymouth,
    United Kingdom

    Site Not Available

  • Salford Royal NHS Foundation Trust

    Salford,
    United Kingdom

    Site Not Available

  • University of Sheffield

    Sheffield,
    United Kingdom

    Active - Recruiting

  • Royal Stoke University Hospital

    Stoke,
    United Kingdom

    Active - Recruiting

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