Trials / Completed
CompletedNCT04129775
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
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 110 (actual)
- Sponsor
- Otonomy, Inc. · Industry
- Sex
- All
- Age
- 21 Years – 64 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | OTO-413 | Single intratympanic injection of Brain-Derived Neurotrophic Factor (BDNF) |
| DRUG | Placebo | Single intratympanic injection of placebo |
Timeline
- Start date
- 2019-10-01
- Primary completion
- 2022-09-05
- Completion
- 2022-09-05
- First posted
- 2019-10-17
- Last updated
- 2022-10-27
Locations
8 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04129775. Inclusion in this directory is not an endorsement.