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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
184

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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
        • Universitätsklinikum 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 Citta 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Humanitas Mirasole SpA

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 25, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2025

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 23, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2023

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 3, 2023

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 3, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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