Study Purpose:
This study will provide extended access to patients and assess longer-term outcomes on patients who have completed the TUDCA-ALS study.Study Status:
Recruiting
Disease:
Amyotrophic Lateral Sclerosis
Study Type:
Interventional
Type of Intervention:
Drug
Intervention Name:
Tauroursodeoxycholic Acid
Placebo:
No
Phase:
Phase 3
Study Chair(s)/Principal Investigator(s):
N/A
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Alberto Albanese, MD / email hidden; JavaScript is required / +39-0282246418
Full Study Summary:
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 Sponsor:
Humanitas Mirasole SpA
Estimated Enrollment:
184
Estimated Study Start Date:
10 / 25 / 2021
Estimated Study Completion Date:
03 / 31 / 2025
Posting Last Modified Date:
03 / 03 / 2023
Date Study Added to neals.org:
03 / 03 / 2023
Minimum Age:
18 Years
Maximum Age:
N/A
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
Katholieke Universiteit Leuven | Active, not recruiting
Leuven
Belgium
Centre Hospitalier Universitaire Limoges | Recruiting
Principal Investigator : Philippe Couratier, MD
Limoges
France
Centre Hospitalier Universitaire de Montpellier | Recruiting
Principal Investigator : Florence Esselin, MD
Montpellier
France
Centre Hospitalier Regional Universitaire de Tours | Recruiting
Principal Investigator : Philippe Corcia, MD
Tours
France
Centre Hospitalier Universitaire de Bordeaux | Recruiting
Principal Investigator : Gwendal Lemasson, MD
Bordeaux
France
Charité - Universitätsmedizin Berlin | Recruiting
Principal Investigator : Thomas Meyer, MD
Berlin
Germany
Universitätsklinikum Carl Gustav Carus Dresden | Recruiting
Principal Investigator : Robert Untucht, MD
Dresden
Germany
Medizinische Hochschule Hannover | Active, not recruiting
Hannover
Germany
Universitätsklinikum Jena | Recruiting
Principal Investigator : Annekathrin Rödiger, MD
Jena
Germany
Universität Ulm | Active, not recruiting
Ulm
Germany
Trinity College Dublin | Active, not recruiting
Dublin
Ireland
Azienda Ospedaliera Santa Maria di Terni | Recruiting
Principal Investigator : Carlo Colosimo, MD
Terni
Italy
AOU Città della Salute e della Scienza di Torino | Active, not recruiting
Torino
Italy
IRCCS Istituto Auxologico Italiano | Recruiting
Principal Investigator : Vincenzo Silani, MD
Milano
Italy
IRCCS Istituto Clinico Humanitas | Active, not recruiting
Rozzano
Italy
AOU Università degli Studi della Campania "Luigi Vanvitelli" | Recruiting
Principal Investigator : Gioacchino Tedeschi, MD
Napoli
Italy
NEuroMuscular Omnicentre. Fondazione Serena Onlus | Recruiting
Principal Investigator : Valeria Sansone, MD
Milano
Italy
Universitair Medisch Centrum Utrecht | Active, not recruiting
Utrecht
Netherlands
The Walton Centre NHS Foundation Trust | Active, not recruiting
Liverpool
United Kingdom
Plymouth Hospitals NHS Trust | Withdrawn
Plymouth
United Kingdom
Salford Royal NHS Foundation Trust | Withdrawn
Salford
United Kingdom
University of Sheffield | Recruiting
Principal Investigator : Christopher J McDermott, MD
Sheffield
United Kingdom
Royal Stoke University Hospital | Recruiting
Principal Investigator : Thomas Lambert, MD
Stoke
United Kingdom