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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04129775
Recruitment Status : Completed
First Posted : October 17, 2019
Last Update Posted : October 27, 2022
Sponsor:
Information provided by (Responsible Party):
Otonomy, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Sensorineural Hearing Loss Drug: OTO-413 Drug: Placebo Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : October 1, 2019
Actual Primary Completion Date : September 5, 2022
Actual Study Completion Date : September 5, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: OTO-413 Drug: OTO-413
Single intratympanic injection of Brain-Derived Neurotrophic Factor (BDNF)
Placebo Comparator: Placebo Drug: Placebo
Single intratympanic injection of placebo


Outcome Measures
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Primary Outcome Measures :
  1. Treatment Emergent Adverse Events (Safety) [ Time Frame: Reported or observed during or after dosing (Day 1) up to the end of study (Day 85 - 12 weeks after dosing) ]
    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.

  2. Otoscopic Examinations (Safety) [ Time Frame: After dosing (Day 1) up to end of study (Day 85 - 12 weeks after dosing) ]
    Clinically significant change form Baseline

  3. Audiometry (Safety) [ Time Frame: After dosing (Day 1) up to end of study (Day 85 - 12 weeks after dosing) ]
    Clinically significant change from Baseline


Other Outcome Measures:
  1. Speech-in-noise Hearing Tests [ Time Frame: Screening, Baseline, 2 weeks (dependent on dose group), 4 weeks, 8 weeks and 12 weeks after dosing ]
    Ability to hear over noise

  2. Electrophysiological Endpoint (dependent on dose group) [ Time Frame: At Screening, 4 weeks, 8 weeks and 12 weeks after dosing ]
    Electrophysiological test of auditory brainstem response to auditory stimuli

  3. Patient Global Impression of Change [ Time Frame: At 2 weeks (dependent on dose group), 4 weeks, 8 weeks and 12 weeks after dosing ]
    Change in overall hearing status, ranging from very much worse (-3) to very much improved (+3)


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04129775


Locations
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United States, Colorado
Colorado Otolaryngology Associates LLC dba Colorado ENT & Allergy
Colorado Springs, Colorado, United States, 80923
United States, Florida
Research Centers of America
Hollywood, Florida, United States, 33024
South Florida ENT Associates or Research Centers of America
Miami, Florida, United States, 33156
University of South Florida
Tampa, Florida, United States, 33612
United States, Kentucky
Advanced ENT and Allergy, PLLC
Louisville, Kentucky, United States, 40220
United States, North Carolina
Piedmont Ear, Nose & Throat Associates
Winston-Salem, North Carolina, United States, 27103
United States, Utah
JBR Clinical Research
Salt Lake City, Utah, United States, 84107
United States, Virginia
Eastern Virginia Medical School, Department of Otolaryngology
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Otonomy, Inc.
More Information
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Responsible Party: Otonomy, Inc.
ClinicalTrials.gov Identifier: NCT04129775    
Other Study ID Numbers: 413-201901
First Posted: October 17, 2019    Key Record Dates
Last Update Posted: October 27, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Otonomy, Inc.:
hearing loss
speech-in-noise
synaptopathy
hearing impairment
hidden hearing loss
Additional relevant MeSH terms:
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Hearing Loss
Deafness
Hearing Loss, Sensorineural
Hearing Disorders
Ear Diseases
 Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases