What side effects are associated with this type of intervention?

Common treatments for ototoxicity, particularly those aimed at preventing amikacin-induced hearing loss, include antioxidants and protective agents like ORC-13661. Known side effects of these treatments can vary. Antioxidants may cause gastrointestinal discomfort, headaches, and allergic reactions. Protective agents like ORC-13661 are still under study, but potential side effects could include mild to moderate gastrointestinal issues, dizziness, and fatigue. It is important to discuss these potential side effects with a healthcare provider to weigh the benefits and risks.

What prior FDA approvals exist?

There are no specific FDA-approved drugs mentioned in the provided context for the treatment of ototoxicity, particularly for preventing amikacin-induced hearing loss. The context does discuss a clinical trial for ORC-13661, which aims to prevent hearing loss in patients undergoing IV amikacin therapy, but it does not mention any prior FDA approvals for similar treatments.

What other types of research exist?

Promising alternatives to ORC-13661 for preventing amikacin-induced ototoxicity include the use of topical treatments containing amitriptyline, ketamine, and baclofen, which have shown some efficacy in improving symptoms of neuropathy. Additionally, further research into the use of glutamine for neuropathy prevention may provide insights into its potential application for ototoxicity prevention.

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ORC-13661 for Preventing Ototoxicity

Phase 2

Waitlist Available

Led By Edwin Rubel, PhD

Research Sponsored by Kevin Winthrop

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 28 (±5) days after study treatment discontinuation or 28 days after 90 days of study treatment, whichever comes first.

Summary

This trial is testing a drug called ORC-13661 to see if it can prevent hearing loss in older patients with a lung infection who are being treated with amikacin. The drug aims to protect the inner ear from damage caused by amikacin. Researchers will compare different doses of ORC-13661 to determine its effectiveness. ORC-13661 is a new drug derived from PROTO-1, which was first identified as protective in initial studies.

Who is the study for?

Adults aged 18-80 with NTM infection requiring IV amikacin treatment, who can take oral medication and follow the study's procedures. They must not have had amikacin in the last 6 months or known resistance to it. Participants need effective contraception if of reproductive potential and cannot be pregnant, lactating, or under correctional supervision.

What is being tested?

The trial is testing ORC-13661's ability to prevent hearing loss from IV amikacin therapy in NTM patients. It compares two different doses of ORC-13661 against a placebo over at least 30 days. Researchers will monitor participants' hearing and overall health during this period.

What are the potential side effects?

While specific side effects for ORC-13661 are not listed, common side effects for medications like it may include gastrointestinal issues, headaches, dizziness, or allergic reactions. The trial aims to see if it prevents ototoxicity (hearing damage) caused by amikacin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 28 (±5) days after study treatment discontinuation or 28 days after 90 days of study treatment, whichever comes first.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 28 (±5) days after study treatment discontinuation or 28 days after 90 days of study treatment, whichever comes first.

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 28 (±5) days after study treatment discontinuation or 28 days after 90 days of study treatment, whichever comes first. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mitigation or Prevention of Ototoxicity

Secondary study objectives

Mitigation or Prevention of hearing impairment with regards to perceived auditory and balance effects

Mitigation or Prevention of hearing impairment with regards to speech perceptions

Mitigation or Prevention of hearing impairment with regards to speech, spatial and quality of hearing

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Low Dose ORC-13661Experimental Treatment1 Intervention

This arm is a daily treatment regimen of study drug (ORC-13661) with a loading dose of 60mg capsules followed by a daily dose of 12mg capsules. Treatment regimen will run concurrently with treatment with IV amikacin. Study drug treatment will continue until treatment with IV amikacin ends or 90 days, whichever is earlier.

Group II: High Dose ORC-13661Experimental Treatment1 Intervention

This arm is a daily treatment regimen of study drug (ORC-13661) with a loading dose of 150mg followed by a daily dose of 30mg. Treatment regimen will run concurrently with treatment with IV amikacin. Study drug treatment will continue until treatment with IV amikacin ends or 90 days, whichever is earlier.

Group III: PlaceboPlacebo Group1 Intervention

This arm is a daily treatment regimen of a placebo with a loading dose and a daily dose of placebo capsules to match the treatment arms. Placebo regimen will run concurrently with treatment with IV amikacin. Placebo regimen will continue until treatment with IV amikacin ends or 90 days, whichever is earlier.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for ototoxicity, such as ORC-13661, aim to prevent or mitigate hearing loss induced by medications like amikacin. These treatments often work by protecting cochlear hair cells from damage. Mechanisms include antioxidant properties that neutralize free radicals, anti-inflammatory effects that reduce cellular stress, and inhibition of apoptotic pathways to prevent cell death. For ototoxicity patients, these mechanisms are crucial as they help preserve hearing function and prevent irreversible damage, thereby maintaining quality of life and communication abilities.

Effects of BDNF and NT-3 on hair cell survival in guinea pig cochlea damaged by kanamycin treatment.