NCT05105958Not yet recruitingPhase 2
Tideglusib for the Treatment of Amyotrophic Lateral Sclerosis
Tideglusib for the Treatment of Amyotrophic Lateral Sclerosis (TIDALS): a Randomized Placebo-controlled Phase II Trial
Source: ClinicalTrials.gov · Last updated 28 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 98 (estimated)
- First submitted
- 4 Oct 2021
- Start date
- 1 Dec 2025
- Primary completion date
- 1 Dec 2025
- Lead sponsor
- University of Zurich
- Diseases
- ALS (motor neurone disease)
- NCT number
- NCT05105958
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 98
- From 1 Dec 2025 to the primary completion date, 1 Dec 2025
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous participation in another clinical study within the preceding 12 weeks
- Presence of any concomitant life-threatening disease or impairment likely to interfere with functional assessment
Other illness
- Any medical condition known to have an association with motor neuron dysfunction which might confound or obscure the diagnosis of ALS
- Evidence of a major psychiatric disorder or clinically evident dementia precluding evaluation of symptoms
- Cardiovascular disorder/arrhythmia
Lab values
- 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
Other
- Proven SOD1- or FUS - mutation
- Tracheostomy or assisted ventilation of any type during the preceding three months
- Pregnancy or breast-feeding females
- Alcoholism
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Bern Coordinator of this site? Confirm its status | Bern | Switzerland | Unknown status |
| University Hospital Geneva Coordinator of this site? Confirm its status | Geneva | Switzerland | Unknown status |
| University Hospital Lausanne Coordinator of this site? Confirm its status | Lausanne | Switzerland | Unknown status |
| Kantonsspital St. Gallen Coordinator of this site? Confirm its status | Sankt Gallen | Switzerland | Unknown status |
| University Hospital Zurich Coordinator of this site? Confirm its status | Zurich | Switzerland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.