Vestibular Function Using Mitochondrial Antioxidant Therapy

NCT05945160 | Withdrawn Early Phase 1 DMC FDA Drug

• 2 other identifiers: HSC20230134H5P30AG044271
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

To determine if supplementation with known mitochondrial antioxidants (alpha lipoic acid (ALA) and CoQ-10) will stabilize or improve vestibular function in older adults.

Conditions

Vestibular Function Disorder

Keywords

Alpha lipoic acid; CoQ10

Outcome Measures

Primary Outcomes (1)

• Slow Harmonic Acceleration

  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.

  Baseline to 12 months

Secondary Outcomes (3)

• Step Velocity Test

  Baseline to 12 months

• Number of falls

  Baseline to 12 months

• Tolerance of supplements

  Baseline to 12 months

Study Arms (2)

Nutritional Supplements Group

EXPERIMENTAL

Alpha Lipoic Acid will be administered as two 300 mg capsules taken once daily CoQ-10 will be administered as two 200mg capsules daily.

Drug: Alpha Lipoic Acid 300mg; Drug: Coenzyme Q10 200mg

Standard of Care Group

NO INTERVENTION

Standard of care treatment for vestibular function.

Interventions

Alpha Lipoic Acid 300mg DRUG

A naturally occuring mitochondrial antioxidant

Also known as: ALA

Nutritional Supplements Group

Coenzyme Q10 200mg DRUG

A naturally occuring mitochondrial antioxidant

Also known as: CoQ10

Nutritional Supplements Group

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Community dwelling non-gender specific aged 65-90 years of age
• For female subjects, confirm that they are post-menopausal
• Diagnosed with vestibular dysfunction
• Able to provide informed consent
• Prepared to adhere to study drug regimen and attend all study visits

You may not qualify if:

• Unable to provide informed consent
• Allergy/sensitivity to the study drugs or any of their ingredients
• Unable to adhere to study drug regimen or to attend study visits.
• Current or past participation within a specified timeframe in another clinical trial, as warranted by the administration of this intervention.
• Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
• Anticoagulant drugs: Anisindione (Miradon), dicumarol and warfarin (Coumadin and Jantoven)
• Participants who are currently undergoing treatment with Insulin, Levothyroxine or chemotherapy drugs.
• Participants who are undergoing treatment with theophylline.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Vestibular Diseases

Interventions

Thioctic Acid; coenzyme Q10

Condition Hierarchy (Ancestors)

Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Carboxylic Acids; Organic Chemicals; Thiophenes; Sulfur Compounds; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids

Study Officials

• Brian Perry, MD

  University of Texas Health Science Center San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 5, 2023
• First Posted: July 14, 2023
• Study Start: January 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 18, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: At study completion when the PI publishes in a peer review journal.

Locations

US (1)