Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:16 PM
Study NCT ID:
NCT05105958
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-28
First Post:
2021-10-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Tideglusib for the Treatment of Amyotrophic Lateral Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000690', 'term': 'Amyotrophic Lateral Sclerosis'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D016472', 'term': 'Motor Neuron Disease'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D057177', 'term': 'TDP-43 Proteinopathies'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C520571', 'term': 'tideglusib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double-blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 98}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-24', 'studyFirstSubmitDate': '2021-10-04', 'studyFirstSubmitQcDate': '2021-10-24', 'lastUpdatePostDateStruct': {'date': '2025-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Exploratory outcome: clinical efficacy', 'timeFrame': '14 weeks', 'description': 'Difference of decline in points on the Revised ALS Functional Rating Scale between the two study arms'}, {'measure': 'Exploratory outcome: vital capacity', 'timeFrame': '14 weeks', 'description': 'slow vital capacity in %'}], 'primaryOutcomes': [{'measure': 'Increase in Alanine Aminotransferase', 'timeFrame': '14 weeks', 'description': 'Increase in Alanine Aminotransferase \\< 3x of Upper Limit of Normal'}], 'secondaryOutcomes': [{'measure': 'Most common side effect', 'timeFrame': '14 weeks', 'description': 'Occurence of diarrhea in less then 18 % of patients'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Amyotrophic Lateral Sclerosis']}, 'descriptionModule': {'briefSummary': '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.\n\nNo 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Possible, probable (clinically or laboratory supported) or definite ALS according to the revised version of the El Escorial criteria\n* Disease duration \\< 18 months\n* Vital capacity of more than 60% of normal (defined as slow vital capacity, best of three measurements)\n* Age more than 18 years\n* On a stable dose of riluzole for at least four weeks or not taking riluzole\n* On a stable dose of edaravone for at least four weeks or not taking edaravone\n* Capable of thoroughly understanding all information given and giving full informed consent according to GCP\n\nExclusion Criteria:\n\n* Previous participation in another clinical study within the preceding 12 weeks\n* Proven SOD1- or FUS - mutation\n* Tracheostomy or assisted ventilation of any type during the preceding three months\n* Pregnancy or breast-feeding females\n* Any medical condition known to have an association with motor neuron dysfunction which might confound or obscure the diagnosis of ALS\n* Presence of any concomitant life-threatening disease or impairment likely to interfere with functional assessment\n* Evidence of a major psychiatric disorder or clinically evident dementia precluding evaluation of symptoms\n* Alcoholism\n* Cardiovascular disorder/arrhythmia\n* Impaired kidney function, defined as creatinine levels of 2.5 x upper limit of normal (ULN)\n* Impaired liver function, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) of 3 x ULN\n* 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'}, 'identificationModule': {'nctId': 'NCT05105958', 'acronym': 'TIDALS', 'briefTitle': 'Tideglusib for the Treatment of Amyotrophic Lateral Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Tideglusib for the Treatment of Amyotrophic Lateral Sclerosis (TIDALS): a Randomized Placebo-controlled Phase II Trial', 'orgStudyIdInfo': {'id': 'TIDALS_01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tideglusib', 'description': 'Patients receive 1000 mg Tideglusib once daily per os', 'interventionNames': ['Drug: Tideglusib']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Patients receive placebo matching Tideglusib 100 mg once daily per os', 'interventionNames': ['Drug: Tideglusib']}], 'interventions': [{'name': 'Tideglusib', 'type': 'DRUG', 'description': '1000 mg/day per os', 'armGroupLabels': ['Placebo', 'Tideglusib']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bern', 'country': 'Switzerland', 'contacts': [{'name': 'Olivier Scheidegger', 'role': 'CONTACT'}], 'facility': 'University Hospital Bern', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}, {'zip': '1205', 'city': 'Geneva', 'country': 'Switzerland', 'contacts': [{'name': 'Annemarie Hübers', 'role': 'CONTACT', 'email': 'annemarie.hubers@hcuge.ch', 'phone': '0795531171'}], 'facility': 'University Hospital Geneva', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}, {'city': 'Lausanne', 'country': 'Switzerland', 'contacts': [{'name': 'David Benninger', 'role': 'CONTACT'}], 'facility': 'University Hospital Lausanne', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}, {'city': 'Sankt Gallen', 'country': 'Switzerland', 'contacts': [{'name': 'Markus Weber', 'role': 'CONTACT'}], 'facility': 'Kantonsspital St. Gallen', 'geoPoint': {'lat': 47.42391, 'lon': 9.37477}}, {'city': 'Zurich', 'country': 'Switzerland', 'contacts': [{'name': 'Hans Jung', 'role': 'CONTACT'}], 'facility': 'University Hospital Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'centralContacts': [{'name': 'Annemarie Hübers', 'role': 'CONTACT', 'email': 'annemarie.hubers@hcuge.ch', 'phone': '0795531171'}], 'overallOfficials': [{'name': 'Annemarie Hübers', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Geneva'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Lausanne Hospitals', 'class': 'OTHER'}, {'name': 'University of Bern', 'class': 'OTHER'}, {'name': 'Cantonal Hospital of St. Gallen', 'class': 'OTHER'}, {'name': 'University Hospital, Geneva', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}