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
1 other identifier
interventional
110
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2019
Typical duration for phase_1
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2019
CompletedFirst Submitted
Initial submission to the registry
October 14, 2019
CompletedFirst Posted
Study publicly available on registry
October 17, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 5, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 5, 2022
CompletedOctober 27, 2022
October 1, 2022
2.9 years
October 14, 2019
October 25, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (3)
Speech-in-noise Hearing Tests
Screening, Baseline, 2 weeks (dependent on dose group), 4 weeks, 8 weeks and 12 weeks after dosing
Electrophysiological Endpoint (dependent on dose group)
At Screening, 4 weeks, 8 weeks and 12 weeks after dosing
Patient Global Impression of Change
At 2 weeks (dependent on dose group), 4 weeks, 8 weeks and 12 weeks after dosing
Study Arms (2)
OTO-413
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Otonomy, Inc.lead
Study Sites (8)
Colorado Otolaryngology Associates LLC dba Colorado ENT & Allergy
Colorado Springs, Colorado, 80923, United States
Research Centers of America
Hollywood, Florida, 33024, United States
South Florida ENT Associates or Research Centers of America
Miami, Florida, 33156, United States
University of South Florida
Tampa, Florida, 33612, United States
Advanced ENT and Allergy, PLLC
Louisville, Kentucky, 40220, United States
Piedmont Ear, Nose & Throat Associates
Winston-Salem, North Carolina, 27103, United States
JBR Clinical Research
Salt Lake City, Utah, 84107, United States
Eastern Virginia Medical School, Department of Otolaryngology
Norfolk, Virginia, 23507, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 14, 2019
First Posted
October 17, 2019
Study Start
October 1, 2019
Primary Completion
September 5, 2022
Study Completion
September 5, 2022
Last Updated
October 27, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share