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RECRUITING
NCT05730283
PHASE2

Prevention of Ototoxicity in NTM Patients Treated With IV Amikacin

Sponsor: Kevin Winthrop

View on ClinicalTrials.gov

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.

Official title: 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 Pulmonary Non-Tuberculous Mycobacterium Disease

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

105

Start Date

2025-06-02

Completion Date

2028-02-29

Last Updated

2026-03-09

Healthy Volunteers

No

Interventions

DRUG

ORC-13661

High-dose intervention (30mg daily)

DRUG

ORC-13661

Low-dose intervention (12mg daily)

DRUG

Placebo

Placebo intervention

Locations (5)

National Jewish Health

Denver, Colorado, United States

Mayo Clinic

Rochester, Minnesota, 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