OTO-313 in Subjects With Unilateral Subjective Tinnitus

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

Sponsors

Lead Sponsor: Otonomy, Inc.

Source Otonomy, Inc.
Brief 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.

Overall Status Completed
Start Date 2021-03-22
Completion Date 2022-06-30
Primary Completion Date 2022-06-30
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Change from Baseline in Tinnitus Functional Index (TFI) Week 4, Week 8
Secondary Outcome
Measure Time Frame
Daily Tinnitus Loudness Start of Lead-in (2 weeks before Baseline) to end of study (Week 16)
Daily Tinnitus Annoyance Start of Lead-in (2 weeks before Baseline) to end of study (Week 16)
Patient Global Impression of Change Week 4, Week 8, Week 12, Week 16
Enrollment 153
Condition
Intervention

Intervention Type: Drug

Intervention Name: OTO-313

Description: Single intratympanic injection

Arm Group Label: OTO-313

Intervention Type: Drug

Intervention Name: Placebo

Description: Single intratympanic injection

Arm Group Label: Placebo

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.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

75 Years

Healthy Volunteers:

No

Overall Contact Contact information is only displayed when the study is recruiting subjects.
Location
Facility:
Central California Clinical Research | Fresno, California, 93720, United States
Breathe Clear Institute | Torrance, California, 90503, United States
University of Colorado, Department of Otolaryngology | Aurora, Colorado, 80045, United States
Colorado ENT & Allergy | Colorado Springs, Colorado, 80923, United States
ENT and Allergy Associates of FL | Boynton Beach, Florida, 33426, United States
ENT and Allergy Associates of Florida, LLC | Delray Beach, Florida, 33484, United States
Research Centers of America | Hollywood, Florida, 33024, United States
ENT and Allergy Associates of Florida, LLC | Plantation, Florida, 33324, United States
ENT and Allergy Associates of Florida, LLC | Port Saint Lucie, Florida, 34952, United States
Ear Research Foundation | Sarasota, Florida, 34239, United States
Rush University Medical Center | Chicago, Illinois, 60612, United States
ChicagoENT | Chicago, Illinois, 60657, United States
Kentuckian Ear, Nose & Throat | Louisville, Kentucky, 40205, United States
Advanced ENT and Allergy, PLLC | Louisville, Kentucky, 40220, United States
Tandem Clinical Research | Marrero, Louisiana, 70072, United States
Center for Specialized Medicine, Department of Otolaryngology-Head and Neck Surgery | Saint Louis, Missouri, 63104, United States
Dartmouth-Hitchcock Medical Center/Mary Hitchcock Memorial Hospital | Lebanon, New Hampshire, 03756, United States
Dent Neurosciences Research Center | Amherst, New York, 14226, United States
Charlotte Eye Ear Nose & Throat Associates, P.A. | Matthews, North Carolina, 28105, United States
Piedmont Ear, Nose & Throat Associates, PA | Winston-Salem, North Carolina, 27103, United States
UC Health Otolaryngology-Head and Neck Surgery | Cincinnati, Ohio, 45267, United States
Department of Otolaryngology-Head and Neck Surgery, Medical University of South Carolina | Charleston, South Carolina, 29425, United States
Carolina Ear, Nose & Throat Clinic/CENTRI Inc. | Orangeburg, South Carolina, 29118, United States
Spartanburg/Greer ENT & Allergy | Spartanburg, South Carolina, 29303, United States
Vanderbilt University Medical Center | Nashville, Tennessee, 37232-8605, United States
Fort Worth ENT | Fort Worth, Texas, 76109, United States
ENT Associates of Texas | McKinney, Texas, 75070, United States
Alamo ENT Associates | San Antonio, Texas, 45227, United States
Chrysalis Clinical Research | Saint George, Utah, 84790, United States
Eastern Virginia Medical School Department of Otolatyngology | Norfolk, Virginia, 23507, United States
Advanced Otolaryngology, P.C. DBA Richmond ENT | Richmond, Virginia, 23235, United States
Universitätsklinikum Carl Gustav Carus Dresden | Dresden, 01307, Germany
HNO - Praxis Göttingen | Göttingen, 37073, Germany
HNO Praxis am Necker | Heidelberg, 69120, Germany
HNO-Gemeinschaftspraxis | Heidelberg, 69126, Germany
Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital | Jena, 07747, Germany
HNO Praxis - Marianne Grohe | Köln, 51061, Germany
Universitätsklinikum Mannheim Klinik für Otorhinolaryngologie, Kopf- und Halschirurgie | Mannheim, 68167, Germany
Klinikum der Universitaet Muenchen | Muenchen, 81377, Germany
Centrum Medyczne Kwiatowa | Bydgoszcz, 85-047, Poland
Centrum Medyczne ZDROWA | Kraków, 31-216, Poland
Centrum Medyczne PROMED | Kraków, 31-411, Poland
MT Medic Specjalistyczna Pralctyka Lekarska Tomasz Stapiński | Krosno, 38-400, Poland
University Hospitals Birmingham NHS Foundation Trust | Birmingham, B15 2TH, United Kingdom
NHS Tayside | Dundee, DD1 9SY, United Kingdom
University Hospitals of Leicester NHS Trust | Leicester, LE1 5WW, United Kingdom
Norfolk and Norwich University Hospitals NHS Trust | Norwich, NR47UY, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust | Sheffield, S10 2JF, United Kingdom
Location Countries

Germany

Poland

United Kingdom

United States

Verification Date

2022-06-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: OTO-313

Type: Experimental

Label: Placebo

Type: Placebo Comparator

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: Randomized, double-blind, placebo-controlled, multicenter

Primary Purpose: Treatment

Masking: Triple (Participant, Investigator, Outcomes Assessor)

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