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Completed

NCT Number: NCT04129775

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

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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Key information

Conditions

Sensorineural Hearing Loss Ear Diseases Hearing Disorders Hearing Loss Hearing Loss, Hidden Hearing Loss, Sensorineural Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

21 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Colorado Otolaryngology Associates LLC dba Colorado ENT & Allergy, Colorado Springs, Colorado, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

OTO-413

Drug

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

Placebo

Drug

Single intratympanic injection of placebo

Primary outcomes

  1. Treatment Emergent Adverse Events (Safety)

    Time frame: Reported or observed during or after dosing (Day 1) up to the end of study (Day 85 - 12 weeks after dosing)

    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.

  2. Otoscopic Examinations (Safety)

    Time frame: After dosing (Day 1) up to end of study (Day 85 - 12 weeks after dosing)

    Clinically significant change form Baseline

  3. Audiometry (Safety)

    Time frame: After dosing (Day 1) up to end of study (Day 85 - 12 weeks after dosing)

    Clinically significant change from Baseline

Other outcomes

  1. Speech-in-noise Hearing Tests

    Time frame: Screening, Baseline, 2 weeks (dependent on dose group), 4 weeks, 8 weeks and 12 weeks after dosing

    Ability to hear over noise

  2. Electrophysiological Endpoint (dependent on dose group)

    Time frame: At Screening, 4 weeks, 8 weeks and 12 weeks after dosing

    Electrophysiological test of auditory brainstem response to auditory stimuli

  3. Patient Global Impression of Change

    Time frame: At 2 weeks (dependent on dose group), 4 weeks, 8 weeks and 12 weeks after dosing

    Change in overall hearing status, ranging from very much worse (-3) to very much improved (+3)

Sponsors and collaborators

Lead sponsor

Otonomy, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Oct 17, 2019
Registry last updated
Oct 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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