Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OTO-413 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OTO-413 | Drug | Single intratympanic injection of Brain-Derived Neurotrophic Factor (BDNF) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | After dosing (Day 1) up to end of study (Day 85 - 12 weeks after dosing) |
| Audiometry (Safety) | Clinically significant change from Baseline | After dosing (Day 1) up to end of study (Day 85 - 12 weeks after dosing) |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Speech-in-noise Hearing Tests | Ability to hear over noise | Screening, Baseline, 2 weeks (dependent on dose group), 4 weeks, 8 weeks and 12 weeks after dosing |
| Electrophysiological Endpoint (dependent on dose group) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colorado Otolaryngology Associates LLC dba Colorado ENT & Allergy | Colorado Springs | Colorado | 80923 | United States | ||
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| D034381 | Hearing Loss |
| D000097942 | Hearing Loss, Hidden |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
Single intratympanic injection of placebo |
|
Electrophysiological test of auditory brainstem response to auditory stimuli
| At Screening, 4 weeks, 8 weeks and 12 weeks after dosing |
| Patient Global Impression of Change | Change in overall hearing status, ranging from very much worse (-3) to very much improved (+3) | At 2 weeks (dependent on dose group), 4 weeks, 8 weeks and 12 weeks after dosing |
| Research Centers of America |
| Hollywood |
| Florida |
| 33024 |
| United States |
| South Florida ENT Associates or Research Centers of America | Miami | Florida | 33156 | United States |
| University of South Florida | Tampa | Florida | 33612 | United States |
| Advanced ENT and Allergy, PLLC | Louisville | Kentucky | 40220 | United States |
| Piedmont Ear, Nose & Throat Associates | Winston-Salem | North Carolina | 27103 | United States |
| JBR Clinical Research | Salt Lake City | Utah | 84107 | United States |
| Eastern Virginia Medical School, Department of Otolaryngology | Norfolk | Virginia | 23507 | United States |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |