Amyotrophic Lateral SclerosisPhase 2TIDALSNCT05105958
Tideglusib for the Treatment of Amyotrophic Lateral Sclerosis
A Phase 2 study testing Tideglusib in people with Amyotrophic Lateral Sclerosis, run by University of Zurich at 5 sites in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- Tideglusib
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 5 sitesSwitzerland
- Study dates
- 1 Dec 2025to 1 Mar 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Switzerland5 sites
University Hospital Bern
Bern
Olivier Scheidegger
University Hospital Geneva
Geneva, 1205
Annemarie Hübers, 0795531171, annemarie.hubers@hcuge.ch
University Hospital Lausanne
Lausanne
David Benninger
Kantonsspital St. Gallen
Sankt Gallen
Markus Weber
University Hospital Zurich
Zurich
Hans Jung
About this study
Official title: Tideglusib for the Treatment of Amyotrophic Lateral Sclerosis (TIDALS): a Randomized Placebo-controlled Phase II Trial
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
- Amyotrophic Lateral Sclerosis
- Being tested
- Tideglusib
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TideglusibDrug
1000 mg/day per os
| Study group | Role | What they receive |
|---|---|---|
| Tideglusib | Experimental | Patients receive 1000 mg Tideglusib once daily per os Receives: Drug: Tideglusib |
| Placebo | Placebo comparator | Patients receive placebo matching Tideglusib 100 mg once daily per os Receives: Drug: Tideglusib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in Alanine Aminotransferase
Increase in Alanine Aminotransferase < 3x of Upper Limit of Normal
Measured: 14 weeks
Secondary outcomes (1)
Most common side effect
Occurence of diarrhea in less then 18 % of patients
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start1 Dec 2025 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lausanne Hospitals, University of Bern, Cantonal Hospital of St. Gallen, University Hospital, Geneva
- Responsible party
- Sponsor
- Investigators
- Annemarie Hübers, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05105958
- Sponsor's protocol ID
- TIDALS_01
- Acronym
- TIDALS
- Status last verified
- Jan 2025
- First submitted
- 4 Oct 2021
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tideglusib for the Treatment of Amyotrophic Lateral Sclerosis (TIDALS): a Randomized Placebo-controlled Phase II Trial
- ClinicalTrials.gov ID
- NCT05105958
- Acronym / sponsor ID
- TIDALS / TIDALS_01
- Conditions
- Amyotrophic Lateral Sclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- University of Lausanne Hospitals, University of Bern, Cantonal Hospital of St. Gallen, University Hospital, Geneva
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 3 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tideglusib | Experimental | Drug: TideglusibPatients receive 1000 mg Tideglusib once daily per os |
| Placebo | Placebo comparator | Drug: TideglusibPatients receive placebo matching Tideglusib 100 mg once daily per os |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tideglusib1000 mg/day per os | Drug | Placebo, Tideglusib |
Primary outcome
Increase in Alanine Aminotransferase
Time frame: 14 weeks
Increase in Alanine Aminotransferase < 3x of Upper Limit of Normal
1 secondary outcome
Most common side effect
Time frame: 14 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Annemarie Hübers principal investigator
University Hospital, Geneva
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tideglusib in people with Amyotrophic Lateral Sclerosis, run by University of Zurich at 5 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Annemarie Hübers (0795531171, annemarie.hubers@hcuge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase in Alanine Aminotransferase (time frame: 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025.