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ORC-13661 for Preventing Ototoxicity

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 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.

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.

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
940 Previous Clinical Trials
7,396,889 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
~70 spots leftby Jan 2027
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