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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2022-09-05

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.

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Detailed Description

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Conditions

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Sensorineural Hearing Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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OTO-413

Group Type EXPERIMENTAL

OTO-413

Intervention Type DRUG

Single intratympanic injection of Brain-Derived Neurotrophic Factor (BDNF)

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Single intratympanic injection of placebo

Interventions

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OTO-413

Single intratympanic injection of Brain-Derived Neurotrophic Factor (BDNF)

Intervention Type DRUG

Placebo

Single intratympanic injection of placebo

Intervention Type DRUG

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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No