Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04129775 · ClinicalTrials.gov registry record · Phase 1
OTO-413 in Subjects With Speech-in-Noise Hearing Impairment
A Phase 1 study of Sensorineural Hearing Loss, sponsored by Otonomy.
- Completed
- Registry status
- Phase 1
- Development phase
- 110
- Enrollment target
- 8
- Study locations
NCT04129775: Completed Phase 1 study of Sensorineural Hearing Loss, sponsored by Otonomy.
NCT04129775 is a Phase 1 study of Sensorineural Hearing Loss that has completed, run by Otonomy. The registered enrollment target is 110 participants, below the 122-participant average among 13 other Sensorineural Hearing Loss trials with a reported enrollment target (10% lower). The trial reports 8 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04129775, a Phase 1 study of Sensorineural Hearing Loss, has completed, sponsored by Otonomy.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 110 participants
- Enrollment target
- 8
- Study locations
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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG OTO-413
Study Locations (8)
Florida
- Research Centers of America - Hollywood
- South Florida ENT Associates or Research Centers of America - Miami
- University of South Florida - Tampa
Colorado
- Colorado Otolaryngology Associates LLC dba Colorado ENT & Allergy - Colorado Springs
Kentucky
- Advanced ENT and Allergy, PLLC - Louisville
North Carolina
- Piedmont Ear, Nose & Throat Associates - Winston-Salem
Utah
- JBR Clinical Research - Salt Lake City
Virginia
- Eastern Virginia Medical School, Department of Otolaryngology - Norfolk
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2019-10-01 |
| Est. Completion | 2022-09-05 |
| Phase | Phase 1 |
What the finished NCT04129775 record still lists
NCT04129775 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, below the 122-participant average among 13 other Sensorineural Hearing Loss trials with a reported enrollment target (10% lower).
The record links to 1 condition, with Sensorineural Hearing Loss appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04129775 lists 8 locations in 6 states (Florida, Colorado, Kentucky).
Frequently Asked Questions
What is clinical trial NCT04129775 about?
NCT04129775 is a clinical study titled "OTO-413 in Subjects With Speech-in-Noise Hearing Impairment". 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.
What is the current status of trial NCT04129775?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 110 participants. The study started on 2019-10-01. Estimated completion is 2022-09-05.
What conditions does trial NCT04129775 study?
This clinical trial studies the following conditions: Sensorineural Hearing Loss.
What interventions are being tested in trial NCT04129775?
The interventions under investigation include: Placebo (DRUG), OTO-413 (DRUG).
Who is sponsoring clinical trial NCT04129775?
This trial is sponsored by Otonomy, which has 20 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04129775 being conducted?
This trial has 8 study locations across Colorado, Florida, Kentucky, North Carolina, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Sensorineural Hearing Loss
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04129775's enrollment target sits among peer trials
110 3rd of 13 higher than 11 of 13 other Sensorineural Hearing Loss trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sensorineural Hearing Loss trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Perceptual Adaptation Following Cochlear Implantation (Aim 3a)
RECRUITING · NA
-
Quantification of Visually Evoked Cortical Potentials in Individuals With Hearing Loss
RECRUITING
-
Effects of Clear Speech on Listening Effort and Memory in Sentence Processing
RECRUITING · NA
-
Long-term Follow-up of a Cochlear Implant With Dexamethasone Eluting Electrode Array
RECRUITING
-
Long-Term Outcomes of Children With Congenital CMV in New York State
RECRUITING
-
Social Influences on Sensorimotor Integration of Speech Production and Perception During Early Vocal Learning
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01530373 · 110 participants · Phase 2
Solifenacin Compared to Clonidine for Reducing Hot Flashes Among Breast Cancer Patients
- NCT02379377 · 110 participants · Phase 1
18F-FSPG PET in Imaging Patients With Liver Cancer Before Undergoing Surgery or Transplant
- NCT02411773 · 110 participants · Phase 1
Sympatholysis in Chronic Kidney Disease
- NCT03190941 · 110 participants · Phase 1
Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*11:01 Patients
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI