RecruitingPhase 2NCT05730283

Prevention of Ototoxicity in NTM Patients Treated With IV Amikacin

Phase 2 Study of the Efficacy and Safety of ORC-13661 for the Prevention of Drug-Induced Hearing Loss in Patients Receiving Intravenous Amikacin Therapy for Non-Tuberculous Mycobacterium Disease


Sponsor

Kevin Winthrop

Enrollment

105 participants

Start Date

Jun 2, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to test the effectiveness of the study drug, ORC-13361, in preventing hearing loss in patients with NTM infection who are undergoing treatment with IV amikacin therapy. The main question this study aims to answer is: * Is ORC-13661 effective for preventing or lessening hearing loss induced by amikacin treatment? * Is ORC-13661 effective for preventing or lessening other measures of hearing impairment? Participants will be asked to take a study drug while they are being treated with IV amikacin. Participants will take study drug for 90 days or until the end of their amikacin treatment, whichever comes first. During this time, researchers will gather clinical data on the participants' health. Researchers will compare three groups - two groups taking different doses of the study drug and one group taking a placebo drug - to see if dose of drug has any effect on preventing hearing loss. A placebo is a look-alike substance that contains no active drug.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called ORC-13661, a drug called ORC-13661, and others for people with ototoxicity, drug-induced. The study is currently recruiting participants at 8 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGORC-13661

High-dose intervention (30mg daily)

DRUGORC-13661

Low-dose intervention (12mg daily)

DRUGPlacebo

Placebo intervention


Locations(8)

University of California, San Francisco

San Francisco, California, United States

National Jewish Health

Denver, Colorado, United States

Johns Hopkins University

Baltimore, Maryland, United States

Mayo Clinic

Rochester, Minnesota, United States

Northwell Health

Manhasset, New York, United States

Oregon Health & Science University

Portland, Oregon, United States

Medical University of South Carolina

Charleston, South Carolina, United States

University of Texas Health Science Center

Tyler, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT05730283


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