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

Primary Purpose

Amyotrophic Lateral Sclerosis

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tauroursodeoxycholic Acid
Sponsored by
Humanitas Mirasole SpA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amyotrophic Lateral Sclerosis focused on measuring Bile acids, Deoxycholic Acid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Katholieke Universiteit Leuven
  • Centre Hospitalier Universitaire de BordeauxRecruiting
  • Centre Hospitalier Universitaire LimogesRecruiting
  • Centre Hospitalier Universitaire de MontpellierRecruiting
  • Centre Hospitalier Regional Universitaire de ToursRecruiting
  • Charité - Universitätsmedizin BerlinRecruiting
  • Universitätsklinikum Carl Gustav Carus DresdenRecruiting
  • Medizinische Hochschule Hannover
  • Universitätsklinikum JenaRecruiting
  • Universität Ulm
  • Trinity College Dublin
  • IRCCS Istituto Auxologico ItalianoRecruiting
  • NEuroMuscular Omnicentre. Fondazione Serena OnlusRecruiting
  • AOU Università degli Studi della Campania "Luigi Vanvitelli"Recruiting
  • IRCCS Istituto Clinico Humanitas
  • Azienda Ospedaliera Santa Maria di TerniRecruiting
  • AOU Città della Salute e della Scienza di Torino
  • Universitair Medisch Centrum Utrecht
  • The Walton Centre NHS Foundation Trust
  • Plymouth Hospitals NHS Trust
  • Salford Royal NHS Foundation Trust
  • University of SheffieldRecruiting
  • Royal Stoke University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Active treatment

Arm Description

Outcomes

Primary Outcome Measures

Long-term safety and tolerability of TUDCA during the open-label phase
Long-term safety and tolerability assessed through adverse reaction, concomitant treatment, and routine biochemistry analyses

Secondary Outcome Measures

Survival time
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).
Change in disease progression and functional impairment
Change in disease progression and functional impairment as measured by ALSFRS-R.

Full Information

First Posted
February 23, 2023
Last Updated
February 23, 2023
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
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1. Study Identification

Unique Protocol Identification Number
NCT05753852
Brief Title
Open Label Extension of TUDCA-ALS Study
Acronym
TUDCA-ALS OLE
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 25, 2021 (Actual)
Primary Completion Date
March 31, 2025 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the 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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis
Keywords
Bile acids, Deoxycholic Acid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
184 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active treatment
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Tauroursodeoxycholic Acid
Other Intervention Name(s)
TUDCA,Tudcabil, Taurolite
Intervention Description
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
Primary Outcome Measure Information:
Title
Long-term safety and tolerability of TUDCA during the open-label phase
Description
Long-term safety and tolerability assessed through adverse reaction, concomitant treatment, and routine biochemistry analyses
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Survival time
Description
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).
Time Frame
18 months
Title
Change in disease progression and functional impairment
Description
Change in disease progression and functional impairment as measured by ALSFRS-R.
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alberto Albanese, MD
Phone
+39-0282246418
Email
alberto.albanese@humanitas.it
Facility Information:
Facility Name
Katholieke Universiteit Leuven
City
Leuven
Country
Belgium
Individual Site Status
Active, not recruiting
Facility Name
Centre Hospitalier Universitaire de Bordeaux
City
Bordeaux
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gwendal Lemasson, MD
Facility Name
Centre Hospitalier Universitaire Limoges
City
Limoges
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe Couratier, MD
Facility Name
Centre Hospitalier Universitaire de Montpellier
City
Montpellier
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Florence Esselin, MD
Facility Name
Centre Hospitalier Regional Universitaire de Tours
City
Tours
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe Corcia, MD
Facility Name
Charité - Universitätsmedizin Berlin
City
Berlin
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Meyer, MD
Facility Name
Universitätsklinikum Carl Gustav Carus Dresden
City
Dresden
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Untucht, MD
Facility Name
Medizinische Hochschule Hannover
City
Hannover
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Universitätsklinikum Jena
City
Jena
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annekathrin Rödiger, MD
Facility Name
Universität Ulm
City
Ulm
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Trinity College Dublin
City
Dublin
Country
Ireland
Individual Site Status
Active, not recruiting
Facility Name
IRCCS Istituto Auxologico Italiano
City
Milano
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincenzo Silani, MD
Facility Name
NEuroMuscular Omnicentre. Fondazione Serena Onlus
City
Milano
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valeria Sansone, MD
Facility Name
AOU Università degli Studi della Campania "Luigi Vanvitelli"
City
Napoli
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gioacchino Tedeschi, MD
Facility Name
IRCCS Istituto Clinico Humanitas
City
Rozzano
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Azienda Ospedaliera Santa Maria di Terni
City
Terni
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlo Colosimo, MD
Facility Name
AOU Città della Salute e della Scienza di Torino
City
Torino
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Universitair Medisch Centrum Utrecht
City
Utrecht
Country
Netherlands
Individual Site Status
Active, not recruiting
Facility Name
The Walton Centre NHS Foundation Trust
City
Liverpool
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Plymouth Hospitals NHS Trust
City
Plymouth
Country
United Kingdom
Individual Site Status
Withdrawn
Facility Name
Salford Royal NHS Foundation Trust
City
Salford
Country
United Kingdom
Individual Site Status
Withdrawn
Facility Name
University of Sheffield
City
Sheffield
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher J McDermott, MD
Facility Name
Royal Stoke University Hospital
City
Stoke
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Lambert, MD

12. IPD Sharing Statement

Learn more about this trial

Open Label Extension of TUDCA-ALS Study

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