OTO-313 in Subjects With Unilateral Subjective Tinnitus

Completed · Phase 2 · Has a placebo group

Conditions studied: Subjective Tinnitus

In brief

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.

Key facts

Study ID

NCT04829214

Run by

Otonomy, Inc.

People needed

153

Starts

2021-03-22

Expected to finish

2022-06-30

Last updated by the study team

2023-01-06

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Central California Clinical Research — Fresno, California, United States
• Breathe Clear Institute — Torrance, California, United States
• University of Colorado, Department of Otolaryngology — Aurora, Colorado, United States
• Colorado ENT & Allergy — Colorado Springs, Colorado, United States
• ENT and Allergy Associates of FL — Boynton Beach, Florida, United States
• ENT and Allergy Associates of Florida, LLC — Delray Beach, Florida, United States
• Research Centers of America — Hollywood, Florida, United States
• ENT and Allergy Associates of Florida, LLC — Plantation, Florida, United States
• ENT and Allergy Associates of Florida, LLC — Port Saint Lucie, Florida, United States
• Ear Research Foundation — Sarasota, Florida, United States
• Rush University Medical Center — Chicago, Illinois, United States
• ChicagoENT — Chicago, Illinois, United States
• Kentuckian Ear, Nose & Throat — Louisville, Kentucky, United States
• Advanced ENT and Allergy, PLLC — Louisville, Kentucky, United States
• Tandem Clinical Research — Marrero, Louisiana, United States
• Center for Specialized Medicine, Department of Otolaryngology-Head and Neck Surgery — St Louis, Missouri, United States
• Dartmouth-Hitchcock Medical Center/Mary Hitchcock Memorial Hospital — Lebanon, New Hampshire, United States
• Dent Neurosciences Research Center — Amherst, New York, United States
• Charlotte Eye Ear Nose & Throat Associates, P.A. — Matthews, North Carolina, United States
• Piedmont Ear, Nose & Throat Associates, PA — Winston-Salem, North Carolina, United States
• UC Health Otolaryngology-Head and Neck Surgery — Cincinnati, Ohio, United States
• Department of Otolaryngology-Head and Neck Surgery, Medical University of South Carolina — Charleston, South Carolina, United States
• Carolina Ear, Nose & Throat Clinic/CENTRI Inc. — Orangeburg, South Carolina, United States
• Spartanburg/Greer ENT & Allergy — Spartanburg, South Carolina, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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