Sensorineural Hearing LossPhase 1/2NCT04129775
OTO-413 in Subjects With Speech-in-Noise Hearing Impairment
A Phase 1/2 study testing OTO-413 in people with Sensorineural Hearing Loss, run by Otonomy, Inc. at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 64 years
- Conditions the study is for
- Sensorineural Hearing Loss
- What is being tested?
- OTO-413
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 8 sitesUnited States
- Study dates
- 1 Oct 2019to 5 Sep 2022
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Colorado Otolaryngology Associates LLC dba Colorado ENT & Allergy
Colorado Springs, Colorado, 80923
Research Centers of America
Hollywood, Florida, 33024
Advanced ENT and Allergy, PLLC
Louisville, Kentucky, 40220
South Florida ENT Associates or Research Centers of America
Miami, Florida, 33156
Eastern Virginia Medical School, Department of Otolaryngology
Norfolk, Virginia, 23507
JBR Clinical Research
Salt Lake City, Utah, 84107
University of South Florida
Tampa, Florida, 33612
Piedmont Ear, Nose & Throat Associates
Winston-Salem, North Carolina, 27103
About this study
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
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
- Being tested
- OTO-413, Placebo
- Keywords
- hearing loss, speech-in-noise, synaptopathy, hearing impairment, hidden hearing loss
- Medical subject headings
- Hearing Loss, Sensorineural, Hearing Loss, Hearing Loss, Hidden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OTO-413Drug
Single intratympanic injection of Brain-Derived Neurotrophic Factor (BDNF)
PlaceboDrug
Single intratympanic injection of placebo
| Study group | Role | What they receive |
|---|---|---|
| OTO-413 | Experimental | Not described Receives: Drug: OTO-413 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Emergent Adverse Events (Safety)
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.
Measured: Reported or observed during or after dosing (Day 1) up to the end of study (Day 85 - 12 weeks after dosing)
Otoscopic Examinations (Safety)
Clinically significant change form Baseline
Measured: After dosing (Day 1) up to end of study (Day 85 - 12 weeks after dosing)
Audiometry (Safety)
Clinically significant change from Baseline
Measured: After dosing (Day 1) up to end of study (Day 85 - 12 weeks after dosing)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2019
- Study start1 Oct 2019
- Primary completion5 Sep 2022
- Study completion5 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sensorineural Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otonomy, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04129775
- Sponsor's protocol ID
- 413-201901
- Status last verified
- Oct 2022
- First submitted
- 14 Oct 2019
- Last updated
- 27 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Foster AC, Anderson JJ, Moore DR, Fuentes MO, Wang Y, Volsky PG, Boyev KP, Sanchez VA. Single Intratympanic Injection of Proprietary Brain-Derived Neurotrophic Factor (OTO-413) in Subjects with Speech-in-Noise Hearing Impairment: a Randomized, Dose Escalating, Double-Blind, Placebo-Controlled Phase 1/2 Study. J Assoc Res Otolaryngol. 2026 Jul 21. doi: 10.1007/s10162-026-01061-z. Online ahead of print.
PubMed 42479273
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04129775
- Acronym / sponsor ID
- 413-201901
- Conditions
- Sensorineural Hearing Loss
- Keywords
- hearing loss, speech-in-noise, synaptopathy, hearing impairment, hidden hearing loss
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Otonomy, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 5 Sep 2022 (actual)
- Study completion
- 5 Sep 2022 (actual)
- First posted
- 17 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OTO-413 | Experimental | Drug: OTO-413 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 21 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OTO-413Single intratympanic injection of Brain-Derived Neurotrophic Factor (BDNF) | Drug | OTO-413 |
| PlaceboSingle intratympanic injection of placebo | Drug | Placebo |
Primary outcome
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.
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
Audiometry (Safety)
Time frame: After dosing (Day 1) up to end of study (Day 85 - 12 weeks after dosing)
Clinically significant change from Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
- Derived from this study: PubMed 42479273Foster AC, Anderson JJ, Moore DR, Fuentes MO, Wang Y, Volsky PG, Boyev KP, Sanchez VA. Single Intratympanic Injection of Proprietary Brain-Derived Neurotrophic Factor (OTO-413) in Subjects with Speech-in-Noise Hearing Impairment: a Randomized, Dose Escalating, Double-Blind, Placebo-Controlled Phase 1/2 Study. J Assoc Res Otolaryngol. 2026 Jul 21. doi: 10.1007/s10162-026-01061-z. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing OTO-413 in people with Sensorineural Hearing Loss, run by Otonomy, Inc. at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04129775, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2022.