Open Label Extension of TUDCA-ALS Study (TUDCA-ALS OLE)

February 23, 2023 updated by: Humanitas Mirasole SpA

Open Label Extension Study to Investigate Long Term Safety, Tolerability and Efficacy of Tauroursodeoxycholic Acid in Patients With ALS Who Completed the 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Anticipated)

184

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Leuven, Belgium
        • Active, not recruiting
        • Katholieke Universiteit Leuven
  • France
      • Bordeaux, France
        • Recruiting
        • Centre Hospitalier Universitaire de Bordeaux
        • Principal Investigator:
          • Gwendal Lemasson, MD
      • Limoges, France
        • Recruiting
        • Centre Hospitalier Universitaire Limoges
        • Principal Investigator:
          • Philippe Couratier, MD
      • Montpellier, France
        • Recruiting
        • Centre Hospitalier Universitaire de Montpellier
        • Principal Investigator:
          • Florence Esselin, MD
      • Tours, France
        • Recruiting
        • Centre Hospitalier Régional Universitaire de Tours
        • Principal Investigator:
          • Philippe Corcia, MD
  • Germany
      • Berlin, Germany
        • Recruiting
        • Charité - Universitätsmedizin Berlin
        • Principal Investigator:
          • Thomas Meyer, MD
      • Dresden, Germany
        • Recruiting
        • Universitatsklinikum Carl Gustav Carus Dresden
        • Principal Investigator:
          • Robert Untucht, MD
      • Hannover, Germany
        • Active, not recruiting
        • Medizinische Hochschule Hannover
      • Jena, Germany
        • Recruiting
        • Universitatsklinikum Jena
        • Principal Investigator:
          • Annekathrin Rödiger, MD
      • Ulm, Germany
        • Active, not recruiting
        • Universität Ulm
  • Ireland
      • Dublin, Ireland
        • Active, not recruiting
        • Trinity College Dublin
  • Italy
      • Milano, Italy
        • Recruiting
        • IRCCS Istituto Auxologico Italiano
        • Principal Investigator:
          • Vincenzo Silani, MD
      • Milano, Italy
        • Recruiting
        • NEuroMuscular Omnicentre. Fondazione Serena Onlus
      • Napoli, Italy
        • Recruiting
        • AOU Università degli Studi della Campania "Luigi Vanvitelli"
        • Principal Investigator:
          • Gioacchino Tedeschi, MD
      • Rozzano, Italy
        • Active, not recruiting
        • IRCCS Istituto Clinico Humanitas
      • Terni, Italy
        • Recruiting
        • Azienda Ospedaliera Santa Maria di Terni
        • Principal Investigator:
          • Carlo Colosimo, MD
      • Torino, Italy
        • Active, not recruiting
        • AOU Città della salute e della scienza di Torino
  • Netherlands
      • Utrecht, Netherlands
        • Active, not recruiting
        • Universitair Medisch Centrum Utrecht
  • United Kingdom
      • Liverpool, United Kingdom
        • Active, not recruiting
        • The Walton Centre NHS Foundation Trust
      • Plymouth, United Kingdom
        • Withdrawn
        • Plymouth Hospitals NHS Trust
      • Salford, United Kingdom
        • Withdrawn
        • Salford Royal NHS Foundation Trust
      • Sheffield, United Kingdom
        • Recruiting
        • University of Sheffield
        • Principal Investigator:
          • Christopher J McDermott, MD
      • Stoke, United Kingdom
        • Recruiting
        • Royal Stoke University Hospital
        • Principal Investigator:
          • Thomas Lambert, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active treatment
Drug: 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 Names:
  • TUDCA,Tudcabil, Taurolite

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long-term safety and tolerability of TUDCA during the open-label phase
Time Frame: 18 months
Long-term safety and tolerability assessed through adverse reaction, concomitant treatment, and routine biochemistry analyses
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival time
Time Frame: 18 months
Survival time measured by death or respiratory insufficiency (defined as tracheostomy or the use of non-invasive ventilation for ≥22 h per day for ≥10 consecutive days).
18 months
Change in disease progression and functional impairment
Time Frame: 18 months
Change in disease progression and functional impairment as measured by ALSFRS-R.
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Humanitas Mirasole SpA

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2021

Primary Completion (Anticipated)

March 31, 2025

Study Completion (Anticipated)

March 31, 2025

Study Registration Dates

First Submitted

February 23, 2023

First Submitted That Met QC Criteria

February 23, 2023

First Posted (Estimate)

March 3, 2023

Study Record Updates

Last Update Posted (Estimate)

March 3, 2023

Last Update Submitted That Met QC Criteria

February 23, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H2020/755094/2017/OLE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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