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

Sensorineural Hearing Loss Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04129775
• Other study ID #: 413-201901
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: October 1, 2019
• Est. completion date: September 5, 2022

Study information

• Verified date: October 2022
• Source: Otonomy, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: September 5, 2022
• Est. primary completion date: September 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Sensorineural
• Sensorineural Hearing Loss

Intervention

Drug:
• OTO-413
Single intratympanic injection of Brain-Derived Neurotrophic Factor (BDNF)
• Placebo
Single intratympanic injection of placebo

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Otonomy, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	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)
Primary	Otoscopic Examinations (Safety)	Clinically significant change form Baseline	After dosing (Day 1) up to end of study (Day 85 - 12 weeks after dosing)
Primary	Audiometry (Safety)	Clinically significant change from Baseline	After dosing (Day 1) up to end of study (Day 85 - 12 weeks after dosing)