Clinical trial NCT04129775: OTO-413 in Subjects With Speech-in-Noise Hearing Impairment
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Sensorineural Hearing Loss
Keywords: hearing loss
speech-in-noise
synaptopathy
hearing impairment
hidden hearing loss
Lead sponsor: Otonomy, Inc.
Sponsor class: INDUSTRY
First posted: 2019-10-17
Enrollment: 110
Sex: ALL
Minimum age (years): 21
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Treatment Emergent Adverse Events (Safety)
timeFrame: Reported or observed during or after dosing (Day 1) up to the end of study (Day 85 - 12 weeks after dosing)
measure: Otoscopic Examinations (Safety)
timeFrame: After dosing (Day 1) up to end of study (Day 85 - 12 weeks after dosing)
measure: Audiometry (Safety)
timeFrame: After dosing (Day 1) up to end of study (Day 85 - 12 weeks after dosing)
Secondary outcomes:
Other outcomes:
measure: Speech-in-noise Hearing Tests
timeFrame: Screening, Baseline, 2 weeks (dependent on dose group), 4 weeks, 8 weeks and 12 weeks after dosing
measure: Electrophysiological Endpoint (dependent on dose group)
timeFrame: At Screening, 4 weeks, 8 weeks and 12 weeks after dosing
measure: Patient Global Impression of Change
timeFrame: At 2 weeks (dependent on dose group), 4 weeks, 8 weeks and 12 weeks after dosing
Locations:
city: Colorado Springs
country: United States
facility: Colorado Otolaryngology Associates LLC dba Colorado ENT & Allergy
state: Colorado
city: Hollywood
country: United States
facility: Research Centers of America
state: Florida
city: Miami
country: United States
facility: South Florida ENT Associates or Research Centers of America
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Louisville
country: United States
facility: Advanced ENT and Allergy, PLLC
state: Kentucky
city: Winston-Salem
country: United States
facility: Piedmont Ear, Nose & Throat Associates
state: North Carolina
city: Salt Lake City
country: United States
facility: JBR Clinical Research
state: Utah
city: Norfolk
country: United States
facility: Eastern Virginia Medical School, Department of Otolaryngology
state: Virginia
Study officials:
References: