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Tideglusib for the Treatment of Amyotrophic Lateral Sclerosis

NCT05105958 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2025-01-28

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Tideglusib

1000 mg/day per os

Sponsors & Collaborators

  • University of Lausanne Hospitals

    collaborator OTHER

  • University of Bern

    collaborator OTHER

  • Cantonal Hospital of St. Gallen

    collaborator OTHER

  • University Hospital, Geneva

    collaborator OTHER

  • University of Zurich

    lead OTHER

Principal Investigators

  • Annemarie Hübers · University Hospital, Geneva

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-01
Primary Completion
2025-12-01
Completion
2026-03-01

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05105958 on ClinicalTrials.gov