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ORC-13661 for Preventing Ototoxicity

Q: How many venues is this clinical investigation being conducted in?

<p>Mayo Clinic in Rochester, <a href="https://www.withpower.com/clinical-trials/oregon">Oregon</a> Health &#x26; Science University in Portland and Medical University of <a href="https://www.withpower.com/clinical-trials/south-carolina">South carolina</a> in Charleston are 3 sites actively recruiting patients for this trial. Additionally, there are 5 other participant-seeking medical centres as part of the study.</p>

Phase 2

Waitlist Available

Led By Kevin L Winthrop, MD, MPH

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.

Awards & highlights

Study Summary

This trial is testing a drug to prevent hearing loss caused by IV amikacin. Patients will take the study drug or placebo for 90 days, and clinical data will be gathered to compare the results.

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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mitigation or Prevention of Ototoxicity

Secondary outcome measures

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Oricula TherapeuticsUNKNOWN

Kevin WinthropLead Sponsor

3 Previous Clinical Trials

684 Total Patients Enrolled

Medical University of South CarolinaOTHER

932 Previous Clinical Trials

7,394,155 Total Patients Enrolled

1 Trials studying Ototoxicity

80 Patients Enrolled for Ototoxicity

Media Library

Low Dose ORC-13661 Clinical Trial Eligibility Overview. Trial Name: NCT05730283 — Phase 2

Ototoxicity Research Study Groups: Low Dose ORC-13661, High Dose ORC-13661, Placebo

Ototoxicity Clinical Trial 2023: Low Dose ORC-13661 Highlights & Side Effects. Trial Name: NCT05730283 — Phase 2

Low Dose ORC-13661 2023 Treatment Timeline for Medical Study. Trial Name: NCT05730283 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this study permit participants of 45 years or older to enroll?

"This clinical trial's inclusion criteria stipulates that suitable candidates must be in-between 18 and 80 years of age. Moreover, we have identified 1 study for minors and 13 trials catering to the elderly population."

Answered by AI

Are there any adverse effects associated with ORC-13661 in large doses?

"Given the Phase 2 status of High Dose ORC-13661, our team at Power has assigned a safety rating of two out of three as there is existing evidence to support its safety yet none for efficacy."

Answered by AI

How many venues is this clinical investigation being conducted in?

"Mayo Clinic in Rochester, Oregon Health & Science University in Portland and Medical University of South carolina in Charleston are 3 sites actively recruiting patients for this trial. Additionally, there are 5 other participant-seeking medical centres as part of the study."

Answered by AI

Is this research available for enrollment at the moment?

"At this moment in time, clinicaltrials.gov specifies that the trial is not recruiting any volunteers. Originally released on August 1st 2023 and last updated February 7th 2023, no new applicants are being accepted for this specific medical study; however, there are 13 other trials actively seeking candidates."

Answered by AI

What are the qualifications for participation in this trial?

"This clinical trial is admitting 105 individuals aged between 18 and 80 who have ototoxicity due to drug usage. Most significantly, these applicants must meet the following criteria: Signing a recent informed consent form demonstrating their willingness to comply with study procedures for its entirety; Having unimpaired judgement when it comes to giving consent without needing legal assistance; Being able of taking oral medication on an everyday basis and adhere to the daily dosing regimen assigned by researchers; For females of reproductive potential agreeing in writing or practicing true abstinence from the moment they signed until one month after discontinuation of treatment depending on preferred lifestyle choice; Male participants being required to practice effective"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Prevention of Ototoxicity in NTM Patients Treated With IV Amikacin

Kevin Winthrop 2024. "Prevention of Ototoxicity in NTM Patients Treated With IV Amikacin". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05730283.

All > Toxicity > Hearing Loss