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Tideglusib for the Treatment of Amyotrophic Lateral Sclerosis (TIDALS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05105958
Recruitment Status : Not yet recruiting
First Posted : November 3, 2021
Last Update Posted : November 3, 2021
Sponsor:
Collaborators:
University of Lausanne Hospitals
University of Zurich
University of Bern
Cantonal Hospital of St. Gallen
Information provided by (Responsible Party):
Annemarie Hübers, University Hospital, Geneva

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Drug: Tideglusib Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-blind
Primary Purpose: Treatment
Official Title: Tideglusib for the Treatment of Amyotrophic Lateral Sclerosis (TIDALS): a Randomized Placebo-controlled Phase II Trial
Estimated Study Start Date : December 1, 2021
Estimated Primary Completion Date : December 1, 2023
Estimated Study Completion Date : March 1, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Tideglusib
Patients receive 1000 mg Tideglusib once daily per os
 Drug: Tideglusib
1000 mg/day per os
Placebo Comparator: Placebo
Patients receive placebo matching Tideglusib 100 mg once daily per os
 Drug: Tideglusib
1000 mg/day per os


Outcome Measures
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Primary Outcome Measures :
  1. Increase in Alanine Aminotransferase [ Time Frame: 14 weeks ]
    Increase in Alanine Aminotransferase < 3x of Upper Limit of Normal


Secondary Outcome Measures :
  1. Most common side effect [ Time Frame: 14 weeks ]
    Occurence of diarrhea in less then 18 % of patients


Other Outcome Measures:
  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 %


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05105958


Contacts
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Contact: Annemarie Hübers 0795531171 annemarie.hubers@hcuge.ch

Locations
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Switzerland
University Hospital Bern
Bern, Switzerland
Contact: Olivier Scheidegger         
University Hospital Geneva
Genève, Switzerland, 1205
Contact: Annemarie Hübers    0795531171    annemarie.hubers@hcuge.ch   
University Hospital Lausanne
Lausanne, Switzerland
Contact: David Benninger         
Kantonsspital St. Gallen
Saint-Gall, Switzerland
Contact: Markus Weber         
University Hospital Zurich
Zürich, Switzerland
Contact: Hans Jung         
Sponsors and Collaborators
University Hospital, Geneva
University of Lausanne Hospitals
University of Zurich
University of Bern
Cantonal Hospital of St. Gallen
Investigators
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Principal Investigator: Annemarie Hübers University Hospital, Geneva
More Information
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Responsible Party: Annemarie Hübers, Principal Investigator, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT05105958    
Other Study ID Numbers: TIDALS_01
First Posted: November 3, 2021    Key Record Dates
Last Update Posted: November 3, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
 Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases