Back to resultsOTO-413 in Subjects With Speech-in-Noise Hearing Impairment
Primary Purpose
Sensorineural Hearing Loss
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
OTO-413
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Sensorineural Hearing Loss focused on measuring hearing loss, speech-in-noise, synaptopathy, hearing impairment, hidden hearing loss
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.
Sites / Locations
- Colorado Otolaryngology Associates LLC dba Colorado ENT & Allergy
- Research Centers of America
- South Florida ENT Associates or Research Centers of America
- University of South Florida
- Advanced ENT and Allergy, PLLC
- Piedmont Ear, Nose & Throat Associates
- JBR Clinical Research
- Eastern Virginia Medical School, Department of Otolaryngology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
OTO-413
Placebo
Arm Description
Outcomes
Primary Outcome Measures
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.
Otoscopic Examinations (Safety)
Clinically significant change form Baseline
Audiometry (Safety)
Clinically significant change from Baseline
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04129775
Brief Title
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
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
September 5, 2022 (Actual)
Study Completion Date
September 5, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otonomy, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sensorineural Hearing Loss
Keywords
hearing loss, speech-in-noise, synaptopathy, hearing impairment, hidden hearing loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OTO-413
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
OTO-413
Intervention Description
Single intratympanic injection of Brain-Derived Neurotrophic Factor (BDNF)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Single intratympanic injection of placebo
Primary Outcome Measure Information:
Title
Treatment Emergent Adverse Events (Safety)
Description
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.
Time Frame
Reported or observed during or after dosing (Day 1) up to the end of study (Day 85 - 12 weeks after dosing)
Title
Otoscopic Examinations (Safety)
Description
Clinically significant change form Baseline
Time Frame
After dosing (Day 1) up to end of study (Day 85 - 12 weeks after dosing)
Title
Audiometry (Safety)
Description
Clinically significant change from Baseline
Time Frame
After dosing (Day 1) up to end of study (Day 85 - 12 weeks after dosing)
Other Pre-specified Outcome Measures:
Title
Speech-in-noise Hearing Tests
Description
Ability to hear over noise
Time Frame
Screening, Baseline, 2 weeks (dependent on dose group), 4 weeks, 8 weeks and 12 weeks after dosing
Title
Electrophysiological Endpoint (dependent on dose group)
Description
Electrophysiological test of auditory brainstem response to auditory stimuli
Time Frame
At Screening, 4 weeks, 8 weeks and 12 weeks after dosing
Title
Patient Global Impression of Change
Description
Change in overall hearing status, ranging from very much worse (-3) to very much improved (+3)
Time Frame
At 2 weeks (dependent on dose group), 4 weeks, 8 weeks and 12 weeks after dosing
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Colorado Otolaryngology Associates LLC dba Colorado ENT & Allergy
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80923
Country
United States
Facility Name
Research Centers of America
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
South Florida ENT Associates or Research Centers of America
City
Miami
State/Province
Florida
ZIP/Postal Code
33156
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Advanced ENT and Allergy, PLLC
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40220
Country
United States
Facility Name
Piedmont Ear, Nose & Throat Associates
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
JBR Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Eastern Virginia Medical School, Department of Otolaryngology
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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OTO-413 in Subjects With Speech-in-Noise Hearing Impairment
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