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

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ClinicalTrials.gov Identifier: NCT04129775
Recruitment Status : Recruiting
First Posted : October 17, 2019
Last Update Posted : October 18, 2019
Sponsor:
Information provided by (Responsible Party):
Otonomy, Inc.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 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
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


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




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: At 2 weeks, 4 weeks, 8 weeks and 12 weeks after dosing ]
    Ability to hear over noise

  2. Electrophysiological Endpoint [ Time Frame: At 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 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)



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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 mild 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.

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, Utah
JBR Clinical Research Recruiting
Salt Lake City, Utah, United States, 84107
Contact: Todd Bertoch, MD    801-261-2000      
Sponsors and Collaborators
Otonomy, Inc.

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Responsible Party: Otonomy, Inc.
ClinicalTrials.gov Identifier: NCT04129775     History of Changes
Other Study ID Numbers: 413-201901
First Posted: October 17, 2019    Key Record Dates
Last Update Posted: October 18, 2019
Last Verified: October 2019
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
Signs and Symptoms