Phase 1 Hearing Loss Trial, Recruiting (NCT05241262)

Phase 1 Hearing Loss Trial, Recruiting NCT05241262 Sponsor: Michio Hirano, MD Condition: Hearing Loss

Printed from Voxsanity (voxsanity.com.au) — NCT05241262 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.

Back to Hearing Loss

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

You are between 18 and 80 years old
A brain scan (using a special type of MRI) has shown that your brain has low levels of a natural antioxidant called glutathione
You carry, or are suspected to carry, a specific genetic change in your mitochondrial DNA called m.3243A>G (genetic testing must confirm this before the study treatment begins)

Who may not be able to join:

Your brain glutathione levels are shown to be normal on the special MRI scan
You are currently pregnant or breastfeeding
You are considered medically unstable, as judged by the lead doctor running the trial
You have an allergy to NAC (N-acetylcysteine) or other medicines that contain sulfur
You are unable to follow the study plan and attend all required appointments or complete all required steps

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.

Last synced 14 July 2026

Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Michio Hirano, MD, Columbia University

Phone: 212-342-5767

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Voxsanity

Clinical trials and treatments, explained plainly · voxsanity.com.au

Date:

To: My Doctor

Re: Clinical trial enquiry

I am writing to enquire about the following clinical trial which may be relevant to my care:

Trial: NCT05241262

Sponsor: Michio Hirano, MD

Phase: Phase 1

Status: Recruiting

Condition: Hearing Loss

Trial contact: 212-342-5767

More information: https://clinicaltrials.gov/study/NCT05241262

Eligibility summary (AI generated)

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

You are between 18 and 80 years old
A brain scan (using a special type of MRI) has shown that your brain has low levels of a natural antioxidant called glutathione
You carry, or are suspected to carry, a specific genetic change in your mitochondrial DNA called m.3243A>G (genetic testing must confirm this before the study treatment begins)

Who may not be able to join:

Your brain glutathione levels are shown to be normal on the special MRI scan
You are currently pregnant or breastfeeding
You are considered medically unstable, as judged by the lead doctor running the trial
You have an allergy to NAC (N-acetylcysteine) or other medicines that contain sulfur
You are unable to follow the study plan and attend all required appointments or complete all required steps

Important: Always verify eligibility with the trial site directly before applying.

Access in Australia: A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.

This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 14 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.

Trial details

Status

Recruiting

Phase

Phase 1

Sponsor

Michio Hirano, MD

Registry

ClinicalTrials.gov

Start date

6 July 2023

Est. completion

1 March 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Maximum tolerated dose (MTD) of NAC

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 14 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov