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NCT Number: NCT05105958

Tideglusib for the Treatment of Amyotrophic Lateral Sclerosis

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.

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Key information

Conditions

Amyotrophic Lateral Sclerosis Central Nervous System Diseases Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital Bern, Bern, Switzerland

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tideglusib

Drug

1000 mg/day per os

Primary outcomes

  1. Increase in Alanine Aminotransferase

    Time frame: 14 weeks

    Increase in Alanine Aminotransferase < 3x of Upper Limit of Normal

Secondary outcomes

  1. Most common side effect

    Time frame: 14 weeks

    Occurence of diarrhea in less then 18 % of patients

Other outcomes

  1. Exploratory outcome: clinical efficacy

    Time frame: 14 weeks

    Difference of decline in points on the Revised ALS Functional Rating Scale between the two study arms

  2. Exploratory outcome: vital capacity

    Time frame: 14 weeks

    slow vital capacity in %

Study contacts

Contact information is provided by the study sponsor or research team.

Annemarie Hübers

CONTACT

[email protected]

0795531171

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

  • Cantonal Hospital of St. Gallen
  • University Hospital, Geneva
  • University of Bern
  • University of Lausanne Hospitals

Registry information

Official study title

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

Acronym: TIDALS

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Nov 3, 2021
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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