OTO-413 in Subjects With Speech-in-Noise Hearing Impairment

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety, tolerability, and exploratory efficacy of OTO-413 administered as an intratympanic injection for the treatment of speech-in-noise hearing impairment.

Official Title
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A Randomized, Double-blind, Placebo-controlled Phase 1/2 Study of OTO-413 Given as a Single Intratympanic Injection in Subjects With Speech-in-noise Hearing Impairment

Conditions
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Sensorineural Hearing Loss

Intervention / Treatment
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* Drug: OTO-413
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has audiometrically-defined normal hearing or up to moderately severe hearing impairment. Subject has self-reported difficulty hearing in noisy environments for at least 6 months prior to Screening. Subject exhibited a speech-in-noise hearing deficit in at least one ear. Exclusion Criteria: Subject is pregnant or lactating. Subject has the following hearing disorders or any other hearing disorders that may impact the efficacy assessments or safety of the subject in the opinion of the Investigator: Meniere's disease, congenital hearing loss, or genetic sensorineural hearing loss. Subject has a cochlear implant or consistently uses a hearing aid. Subject has worked at least 5 years as a professional musician or has had at least 15 years of formal musical training. Subject self-reports bothersome, subjective tinnitus and is consistently aware of their tinnitus throughout much of the waking day.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OTO-413<br> | Drug: OTO-413<br>* Single intratympanic injection of Brain-Derived Neurotrophic Factor (BDNF)<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Single intratympanic injection of placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Emergent Adverse Events (Safety) | An adverse event (AE) is any unfavorable and unintended diagnosis, symptom, sign, syndrome or disease which occurs during the study, having been absent at baseline, or if present at baseline, appears to worsen. | Reported or observed during or after dosing (Day 1) up to the end of study (Day 85 - 12 weeks after dosing) | 
| Otoscopic Examinations (Safety) | Clinically significant change form Baseline | After dosing (Day 1) up to end of study (Day 85 - 12 weeks after dosing) | 
| Audiometry (Safety) | Clinically significant change from Baseline | After dosing (Day 1) up to end of study (Day 85 - 12 weeks after dosing) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hearing loss, speech-in-noise, synaptopathy, hearing impairment, hidden hearing loss