Open Label Extension of TUDCA-ALS Study

Amyotrophic Lateral Sclerosis Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05753852
• Other study ID #: H2020/755094/2017/OLE
• Status: Recruiting
• Phase: Phase 3
• Start date: October 25, 2021
• Est. completion date: March 31, 2025

Study information

• Verified date: February 2023
• Source: Humanitas Mirasole SpA
• Contact: Alberto Albanese, MD
• Phone: +39-0282246418
• Email: alberto.albanese[@]humanitas.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 184
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease

Intervention

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

Locations

Country	Name	City	State
Belgium	Katholieke Universiteit Leuven	Leuven
France	Centre Hospitalier Universitaire de Bordeaux	Bordeaux
France	Centre Hospitalier Universitaire Limoges	Limoges
France	Centre Hospitalier Universitaire de Montpellier	Montpellier
France	Centre Hospitalier Regional Universitaire de Tours	Tours
Germany	Charité - Universitätsmedizin Berlin	Berlin
Germany	Universitätsklinikum Carl Gustav Carus Dresden	Dresden
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Universitätsklinikum Jena	Jena
Germany	Universität Ulm	Ulm
Ireland	Trinity College Dublin	Dublin
Italy	IRCCS Istituto Auxologico Italiano	Milano
Italy	NEuroMuscular Omnicentre. Fondazione Serena Onlus	Milano
Italy	AOU Università degli Studi della Campania "Luigi Vanvitelli"	Napoli
Italy	IRCCS Istituto Clinico Humanitas	Rozzano
Italy	Azienda Ospedaliera Santa Maria di Terni	Terni
Italy	AOU Città della Salute e della Scienza di Torino	Torino
Netherlands	Universitair Medisch Centrum Utrecht	Utrecht
United Kingdom	The Walton Centre NHS Foundation Trust	Liverpool
United Kingdom	Plymouth Hospitals NHS Trust	Plymouth
United Kingdom	Salford Royal NHS Foundation Trust	Salford
United Kingdom	University of Sheffield	Sheffield
United Kingdom	Royal Stoke University Hospital	Stoke

Sponsors (10)

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

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Ireland,  Italy,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).	18 months
Secondary	Change in disease progression and functional impairment	Change in disease progression and functional impairment as measured by ALSFRS-R.	18 months