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

NCT04129775 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2022-10-27

No results posted yet for this study

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.

Conditions

  • Sensorineural Hearing Loss

Interventions

DRUG

OTO-413

Single intratympanic injection of Brain-Derived Neurotrophic Factor (BDNF)

DRUG

Placebo

Single intratympanic injection of placebo

Sponsors & Collaborators

  • Otonomy, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-01
Primary Completion
2022-09-05
Completion
2022-09-05
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04129775 on ClinicalTrials.gov