Tideglusib for the Treatment of Amyotrophic Lateral Sclerosis

Amyotrophic Lateral Sclerosis Clinical Trial

— TIDALS  

Official title:

Tideglusib for the Treatment of Amyotrophic Lateral Sclerosis (TIDALS): a Randomized Placebo-controlled Phase II Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05105958
• Other study ID #: TIDALS_01
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: December 1, 2025
• Est. completion date: March 1, 2026

Study information

• Verified date: June 2023
• Source: University Hospital, Geneva
• Contact: Annemarie Hübers
• Phone: 0795531171
• Email: annemarie.hubers[@]hcuge.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Amyotrophic lateral sclerosis (ALS) is a severe neurodegenerative condition, mainly characterized by progressive weakness and wasting of the limbs, the respiratory and bulbar muscles. Respiratory insufficiency leads to a fatal outcome after a mean diseases duration of only three to five years. The disease is characterized by pathological accumulations of a protein called TDP-43, which can be found large cortical and sub-cortical areas of post-mortem ALS brains. No causal treatment for this condition is known to date, and there is a large unmet need to develop new strategies in order to halt or slow down its progression. The aim of this study is to test the safety and tolerability of Tideglusib, a treatment that is already in clinical trials for other neuromuscular conditions, in patients with ALS. It is assumed that this drug may have a significant therapeutic benefit in this population due to his mode of action: In the ALS mouse model, Tideglusib decreases significantly the amount of accumulated TDP-43 proteins within the cells.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 98
• Est. completion date: March 1, 2026
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Possible, probable (clinically or laboratory supported) or definite ALS according to the revised version of the El Escorial criteria
• Disease duration < 18 months
• Vital capacity of more than 60% of normal (defined as slow vital capacity, best of three measurements)
• Age more than 18 years
• On a stable dose of riluzole for at least four weeks or not taking riluzole
• On a stable dose of edaravone for at least four weeks or not taking edaravone
• Capable of thoroughly understanding all information given and giving full informed consent according to GCP

Exclusion Criteria:

• Previous participation in another clinical study within the preceding 12 weeks
• Proven SOD1- or FUS - mutation
• Tracheostomy or assisted ventilation of any type during the preceding three months
• Pregnancy or breast-feeding females
• Any medical condition known to have an association with motor neuron dysfunction which might confound or obscure the diagnosis of ALS
• Presence of any concomitant life-threatening disease or impairment likely to interfere with functional assessment
• Evidence of a major psychiatric disorder or clinically evident dementia precluding evaluation of symptoms
• Alcoholism
• Cardiovascular disorder/arrhythmia
• Impaired kidney function, defined as creatinine levels of 2.5 x upper limit of normal (ULN)
• Impaired liver function, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) of 3 x ULN
• Liable to be not cooperative or comply with trial requirements as assessed by the investigator, or unable to be reached in the case of emergency

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

Drug:
• Tideglusib
1000 mg/day per os

Locations

Country	Name	City	State
Switzerland	University Hospital Bern	Bern
Switzerland	University Hospital Geneva	Genève
Switzerland	University Hospital Lausanne	Lausanne
Switzerland	Kantonsspital St. Gallen	Saint-Gall
Switzerland	University Hospital Zurich	Zürich

Sponsors (5)

Lead Sponsor	Collaborator
University Hospital, Geneva	Cantonal Hospital of St. Gallen, University of Bern, University of Lausanne Hospitals, University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory outcome: clinical efficacy	Difference of decline in points on the Revised ALS Functional Rating Scale between the two study arms	14 weeks
Other	Exploratory outcome: vital capacity	slow vital capacity in %	14 weeks
Primary	Increase in Alanine Aminotransferase	Increase in Alanine Aminotransferase < 3x of Upper Limit of Normal	14 weeks
Secondary	Most common side effect	Occurence of diarrhea in less then 18 % of patients	14 weeks