Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-26 @ 3:15 AM
Study NCT ID:
NCT05945160
Status:
WITHDRAWN
Last Update Posted:
2023-10-18
First Post:
2023-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vestibular Function Using Mitochondrial Antioxidant Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015837', 'term': 'Vestibular Diseases'}], 'ancestors': [{'id': 'D007759', 'term': 'Labyrinth Diseases'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008063', 'term': 'Thioctic Acid'}, {'id': 'C024989', 'term': 'coenzyme Q10'}], 'ancestors': [{'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two arm non-blinded controlled clinical trial. Subjects will be randomized 1: 1 either into the investigational antioxidant arm or the standard of care, no study drug arm.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Funding was terminated, the study will not enroll any subjects', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2024-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-16', 'studyFirstSubmitDate': '2023-07-05', 'studyFirstSubmitQcDate': '2023-07-05', 'lastUpdatePostDateStruct': {'date': '2023-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Slow Harmonic Acceleration', 'timeFrame': 'Baseline to 12 months', 'description': 'Change in vestibular function using the slow harmonic acceleration rotating chair test to measure change, phase and time constant. The sinusoidal harmonic acceleration (SHA) test is a diagnostic procedure used to evaluate the vestibular system, which is responsible for maintaining balance. In the sinusoidal harmonic acceleration test, a person sits in a rotational chair that moves smoothly in controlled, rhythmic oscillations. These movements stimulate the vestibular system and induce eye movements that reflect dynamic vestibular function. Abnormal findings on the SHA test may suggest unilateral or bilateral vestibular dysfunction and provide insights into the status of central compensation for vestibular issues.'}], 'secondaryOutcomes': [{'measure': 'Step Velocity Test', 'timeFrame': 'Baseline to 12 months', 'description': 'Step velocity test involves sudden chair rotations and abrupt stops in both directions, which generate compensatory eye movements predominantly in response to the stimulated side. Abnormal findings during this test can suggest problems with the vestibular system, providing additional information about the affected side.'}, {'measure': 'Number of falls', 'timeFrame': 'Baseline to 12 months', 'description': 'A count of number of falls experienced'}, {'measure': 'Tolerance of supplements', 'timeFrame': 'Baseline to 12 months', 'description': 'Number of adverse events experienced'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Alpha lipoic acid', 'CoQ10'], 'conditions': ['Vestibular Function Disorder']}, 'descriptionModule': {'briefSummary': 'To determine if supplementation with known mitochondrial antioxidants (alpha lipoic acid (ALA) and CoQ-10) will stabilize or improve vestibular function in older adults.', 'detailedDescription': 'The subjects will be divided into two groups, half will be given daily supplementation with ALA and CoQ-10. The second group will only receive standard of care treatment, with no study drug intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Community dwelling non-gender specific aged 65-90 years of age\n2. For female subjects, confirm that they are post-menopausal\n3. Diagnosed with vestibular dysfunction\n4. Able to provide informed consent\n5. Prepared to adhere to study drug regimen and attend all study visits\n\nExclusion Criteria:\n\n1. Unable to provide informed consent\n2. Allergy/sensitivity to the study drugs or any of their ingredients\n3. Unable to adhere to study drug regimen or to attend study visits.\n4. Current or past participation within a specified timeframe in another clinical trial, as warranted by the administration of this intervention.\n5. Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.\n6. Anticoagulant drugs: Anisindione (Miradon), dicumarol and warfarin (Coumadin and Jantoven)\n7. Participants who are currently undergoing treatment with Insulin, Levothyroxine or chemotherapy drugs.\n8. Participants who are undergoing treatment with theophylline.'}, 'identificationModule': {'nctId': 'NCT05945160', 'briefTitle': 'Vestibular Function Using Mitochondrial Antioxidant Therapy', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center at San Antonio'}, 'officialTitle': 'A Randomized Controlled Study Using Alpha Lipoic Acid and CoQ-10 to Determine if Vestibular Function Can be Improved or Maintained Over the Course of One Year', 'orgStudyIdInfo': {'id': 'HSC20230134H'}, 'secondaryIdInfos': [{'id': '5P30AG044271', 'link': 'https://reporter.nih.gov/quickSearch/5P30AG044271', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nutritional Supplements Group', 'description': 'Alpha Lipoic Acid will be administered as two 300 mg capsules taken once daily CoQ-10 will be administered as two 200mg capsules daily.', 'interventionNames': ['Drug: Alpha Lipoic Acid 300mg', 'Drug: Coenzyme Q10 200mg']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of Care Group', 'description': 'Standard of care treatment for vestibular function.'}], 'interventions': [{'name': 'Alpha Lipoic Acid 300mg', 'type': 'DRUG', 'otherNames': ['ALA'], 'description': 'A naturally occuring mitochondrial antioxidant', 'armGroupLabels': ['Nutritional Supplements Group']}, {'name': 'Coenzyme Q10 200mg', 'type': 'DRUG', 'otherNames': ['CoQ10'], 'description': 'A naturally occuring mitochondrial antioxidant', 'armGroupLabels': ['Nutritional Supplements Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Health Science Center at San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Brian Perry, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas Health Science Center San Antonio'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'At study completion when the PI publishes in a peer review journal.', 'ipdSharing': 'YES', 'description': 'All collected deidentified IPD that underlie results in a publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center at San Antonio', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}