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

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

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.

Study Overview

• Status: Completed
• Conditions: Sensorineural Hearing Loss
• Intervention / Treatment: Drug: OTO-413; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Colorado Springs, Colorado, United States, 80923
      • Colorado Otolaryngology Associates LLC dba Colorado ENT & Allergy
  • Florida
    • Hollywood, Florida, United States, 33024
      • Research Centers of America
    • Miami, Florida, United States, 33156
      • South Florida ENT Associates or Research Centers of America
    • Tampa, Florida, United States, 33612
      • University of South Florida
  • Kentucky
    • Louisville, Kentucky, United States, 40220
      • Advanced ENT and Allergy, PLLC
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Piedmont Ear, Nose & Throat Associates
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • JBR Clinical Research
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Eastern Virginia Medical School, Department of Otolaryngology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Speech-in-noise Hearing Tests	Ability to hear over noise	Screening, Baseline, 2 weeks (dependent on dose group), 4 weeks, 8 weeks and 12 weeks after dosing
Electrophysiological Endpoint (dependent on dose group)	Electrophysiological test of auditory brainstem response to auditory stimuli	At Screening, 4 weeks, 8 weeks and 12 weeks after dosing
Patient Global Impression of Change	Change in overall hearing status, ranging from very much worse (-3) to very much improved (+3)	At 2 weeks (dependent on dose group), 4 weeks, 8 weeks and 12 weeks after dosing

Collaborators and Investigators

• Sponsor: Otonomy, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): September 5, 2022
• Study Completion (Actual): September 5, 2022

Study Registration Dates

• First Submitted: October 14, 2019
• First Submitted That Met QC Criteria: October 14, 2019
• First Posted (Actual): October 17, 2019

Study Record Updates

• Last Update Posted (Actual): October 27, 2022
• Last Update Submitted That Met QC Criteria: October 25, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: synaptopathy; hearing loss; speech-in-noise; hearing impairment; hidden hearing loss
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness; Hearing Loss, Sensorineural
• Other Study ID Numbers: 413-201901

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No