OTO-313 in Subjects With Unilateral Subjective Tinnitus

Study Overview
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Brief Summary
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The purpose of this study is to determine the efficacy of OTO-313 in subjects with unilateral tinnitus and to determine the safety and tolerability of OTO-313 in subjects with unilateral tinnitus.

Official Title
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A Randomized, Double-blind, Placebo-controlled Phase 2 Study of OTO-313 Given as a Single Intratympanic Injection in Subjects With Unilateral Subjective Tinnitus

Conditions
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Subjective Tinnitus

Intervention / Treatment
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* Drug: OTO-313
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has early-onset subjective unilateral tinnitus that is persistent (consistently aware of their tinnitus throughout much of the waking day). Subject is able to use the diary to complete their daily tinnitus ratings. Subject's tinnitus is likely of cochlear origin, e.g., associated with sensorineural hearing loss; acute hearing loss from noise trauma, barotrauma, or traumatic cochlear injury (acute acoustic trauma, blast trauma, middle ear surgery, inner ear barotrauma); age related hearing loss; resolved otitis media; ototoxic drug exposure. Subject is willing to comply with the protocol and attend all study visits. Exclusion Criteria: Subject has pulsatile tinnitus, temporomandibular joint disease (TMJ) associated with tinnitus perception, tinnitus resulting from traumatic head or neck injury, or tinnitus resulting from a tumor or stroke. Subject is pregnant, lactating, or undergoing fertility treatment. Subject has other clinically significant illness, medical condition or medical history at Screening or Baseline that, in the Investigator's opinion, would likely reduce the safety of study participation or compliance with study procedures.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, double-blind, placebo-controlled, multicenter
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OTO-313<br> | Drug: OTO-313<br>* Single intratympanic injection<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Single intratympanic injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Tinnitus Functional Index (TFI) Responders at Weeks 4 and at Week 8 | The TFI is a validated, 25-item questionnaire; index score from 0 to 100; higher scores indicate a greater problem with tinnitus. A responder is considered as any subject with at least a 13-point improvement from Baseline on the (TFI). This responder analysis required both Week 4 and Week 8 to have a 13-point improvement from Baseline. | Week 4 and Week 8 (both had to meet criterion for the subject to be considered a responder) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Daily Tinnitus Loudness at Week 8 | Numerical rating scale (NRS) from 0 (No Tinnitus) to 10 (Extremely Loud Tinnitus) collected every day. Post-baseline weekly NRS scores will be calculated as the average score of all recorded diary entries within each study week. | The average is calculated for the Baseline and for each study week. Reported here is the change from Baseline to Week 8. | 
| Change From Baseline in Daily Tinnitus Annoyance at Week 8 | Numerical rating scale from 0 (Not Annoying) to 10 (Extremely Annoying) collected every day. Post-baseline weekly NRS scores will be calculated as the average score of all recorded diary entries within each study week. | The average is calculated for the Baseline and for each study week. Reported here is the change from Baseline to Week 8 | 
| Patient Global Impression of Change at Week 8 | Change in overall tinnitus status as perceived by the subject as assessed at the Week 8 visit. Subjects were asked, Since the beginning of the clinical study, how would you rate your tinnitus? and had the choice to answer from very much worse (-3) to very much improved (3). The mean change from baseline at Week 8 is reported here. | Week 8 reported here | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intratympanic injection, IT injection, gacyclidine, tinnitus