Phase 2
N=153
OTO-313 in Subjects With Unilateral Subjective Tinnitus
Subjective Tinnitus
Bottom Line
View on ClinicalTrials.gov: NCT04829214 ↗Enrolled (actual)
153
Serious AEs
1.3%
Results posted
Jan 2023
Primary outcome: Primary: Percentage of Tinnitus Functional Index (TFI) Responders at Weeks 4 and at Week 8 — 20; 27 Participants — p==0.385
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- OTO-313 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Otonomy, Inc.
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Tinnitus Functional Index (TFI) Responders at Weeks 4 and at Week 8 |
20; 27 | =0.385 |
| SECONDARY Change From Baseline in Daily Tinnitus Loudness at Week 8 |
-0.67; -0.90 | — |
| SECONDARY Change From Baseline in Daily Tinnitus Annoyance at Week 8 |
-0.73; -1.11 | — |
| SECONDARY Patient Global Impression of Change at Week 8 |
0.32; 0.36 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04829214). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.