Tideglusib for the Treatment of Amyotrophic Lateral Sclerosis

Sponsor
University of Zurich
Study ID
NCT05105958
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tideglusib — DRUG
    1000 mg/day per os

Study Details

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.

Key Dates

First listed
Nov 3, 2021
Start date
Dec 1, 2025
Status verified
Jan 2025
Primary completion
Dec 1, 2025
Completion
Mar 1, 2026

Study Design

Enrollment
98 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tideglusib
    Patients receive 1000 mg Tideglusib once daily per os
  • Placebo Comparator: Placebo
    Patients receive placebo matching Tideglusib 100 mg once daily per os

Primary Outcome Measure

Increase in Alanine Aminotransferase [ Time Frame: 14 weeks ]

Central Contacts

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