NCT05753852

Brief Summary

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

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
184

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2021

Typical duration for phase_3

Geographic Reach
7 countries

23 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 25, 2021

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

February 23, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 3, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

March 3, 2023

Status Verified

February 1, 2023

Enrollment Period

3.4 years

First QC Date

February 23, 2023

Last Update Submit

February 23, 2023

Conditions

Amyotrophic Lateral Sclerosis

Keywords

Bile acidsDeoxycholic Acid

Outcome Measures

Primary Outcomes (1)

  • 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

    18 months

Secondary Outcomes (2)

  • Survival time

    18 months

  • Change in disease progression and functional impairment

    18 months

Study Arms (1)

Active treatment

EXPERIMENTAL
Drug: Tauroursodeoxycholic Acid

Interventions

Tauroursodeoxycholic AcidDRUG

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

Also known as: TUDCA,Tudcabil, Taurolite
Active treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

Katholieke Universiteit Leuven

Leuven, Belgium

ACTIVE NOT RECRUITING

Centre Hospitalier Universitaire de Bordeaux

Bordeaux, France

RECRUITING

Centre Hospitalier Universitaire Limoges

Limoges, France

RECRUITING

Centre Hospitalier Universitaire de Montpellier

Montpellier, France

RECRUITING

Centre Hospitalier Regional Universitaire de Tours

Tours, France

RECRUITING

Charité - Universitätsmedizin Berlin

Berlin, Germany

RECRUITING

Universitätsklinikum Carl Gustav Carus Dresden

Dresden, Germany

RECRUITING

Medizinische Hochschule Hannover

Hanover, Germany

ACTIVE NOT RECRUITING

Universitätsklinikum Jena

Jena, Germany

RECRUITING

Universität Ulm

Ulm, Germany

ACTIVE NOT RECRUITING

Trinity College Dublin

Dublin, Ireland

ACTIVE NOT RECRUITING

IRCCS Istituto Auxologico Italiano

Milan, Italy

RECRUITING

NEuroMuscular Omnicentre. Fondazione Serena Onlus

Milan, Italy

RECRUITING

AOU Università degli Studi della Campania "Luigi Vanvitelli"

Napoli, Italy

RECRUITING

IRCCS Istituto Clinico Humanitas

Rozzano, Italy

ACTIVE NOT RECRUITING

Azienda Ospedaliera Santa Maria di Terni

Terni, Italy

RECRUITING

AOU Città della Salute e della Scienza di Torino

Torino, Italy

ACTIVE NOT RECRUITING

Universitair Medisch Centrum Utrecht

Utrecht, Netherlands

ACTIVE NOT RECRUITING

The Walton Centre NHS Foundation Trust

Liverpool, United Kingdom

ACTIVE NOT RECRUITING

Plymouth Hospitals NHS Trust

Plymouth, United Kingdom

WITHDRAWN

Salford Royal NHS Foundation Trust

Salford, United Kingdom

WITHDRAWN

University of Sheffield

Sheffield, United Kingdom

RECRUITING

Royal Stoke University Hospital

Stoke, United Kingdom

RECRUITING

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

ursodoxicoltaurine

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

Alberto Albanese, MD

CONTACT

+39-0282246418alberto.albanese@humanitas.it

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2023

First Posted

March 3, 2023

Study Start

October 25, 2021

Primary Completion

March 31, 2025

Study Completion

March 31, 2025

Last Updated

March 3, 2023

Record last verified: 2023-02

Locations

GB(5)FR(4)NL(1)DE(5)IT(6)BE(1)IE(1)