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Clinical trial

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

ID
Name
413-201901
Description
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 arms
Trial start
2019-10-01
Estimated PCD
2022-09-05
Trial end
2022-09-05
Status
Completed
Phase
Early phase I
Treatment
OTO-413
Single intratympanic injection of Brain-Derived Neurotrophic Factor (BDNF)
Arms:
OTO-413
Placebo
Single intratympanic injection of placebo
Arms:
Placebo
Size
110
Primary endpoint
Treatment Emergent Adverse Events (Safety)
Reported or observed during or after dosing (Day 1) up to the end of study (Day 85 - 12 weeks after dosing)
Otoscopic Examinations (Safety)
After dosing (Day 1) up to end of study (Day 85 - 12 weeks after dosing)
Audiometry (Safety)
After dosing (Day 1) up to end of study (Day 85 - 12 weeks after dosing)
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 110, 'type': 'ACTUAL'}}
Updated at
2022-10-27

1 organization

2 products

1 indication

Product
OTO-413
Indication
Hearing Loss, Sensorineural
Organization
Otonomy
Product
Placebo