OTO-313 in Subjects With Unilateral Subjective Tinnitus

NCT04829214 | Completed Phase 2 Results FDA Drug

• 1 other identifier: OTO-313-201
• Study Type: interventional
• Target: 153
• Locations: 4 countries
• Sites: 48

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.

Conditions

Subjective Tinnitus

Keywords

intratympanic injection; IT injection; gacyclidine; tinnitus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change From Baseline in Daily Tinnitus Loudness at Week 8

  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

  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

  Week 8 reported here

Other Outcomes (1)

• Otoscopic Examinations - Presence of Perforation in the Treated Ear at Week 16 (Final Visit)

  After dosing (Baseline) up to end of study (16 Weeks)

Study Arms (2)

OTO-313

EXPERIMENTAL

Drug: OTO-313

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

OTO-313 DRUG

Single intratympanic injection

OTO-313

Placebo DRUG

Single intratympanic injection

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Otonomy, Inc.: lead

Study Sites (48)

Central California Clinical Research

Fresno, California, 93720, United States

Location

Breathe Clear Institute

Torrance, California, 90503, United States

Location

University of Colorado, Department of Otolaryngology

Aurora, Colorado, 80045, United States

Location

Colorado ENT & Allergy

Colorado Springs, Colorado, 80923, United States

Location

ENT and Allergy Associates of FL

Boynton Beach, Florida, 33426, United States

Location

ENT and Allergy Associates of Florida, LLC

Delray Beach, Florida, 33484, United States

Location

Research Centers of America

Hollywood, Florida, 33024, United States

Location

ENT and Allergy Associates of Florida, LLC

Plantation, Florida, 33324, United States

Location

ENT and Allergy Associates of Florida, LLC

Port Saint Lucie, Florida, 34952, United States

Location

Ear Research Foundation

Sarasota, Florida, 34239, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

ChicagoENT

Chicago, Illinois, 60657, United States

Location

Kentuckian Ear, Nose & Throat

Louisville, Kentucky, 40205, United States

Location

Advanced ENT and Allergy, PLLC

Louisville, Kentucky, 40220, United States

Location

Tandem Clinical Research

Marrero, Louisiana, 70072, United States

Location

Center for Specialized Medicine, Department of Otolaryngology-Head and Neck Surgery

St Louis, Missouri, 63104, United States

Location

Dartmouth-Hitchcock Medical Center/Mary Hitchcock Memorial Hospital

Lebanon, New Hampshire, 03756, United States

Location

Dent Neurosciences Research Center

Amherst, New York, 14226, United States

Location

Charlotte Eye Ear Nose & Throat Associates, P.A.

Matthews, North Carolina, 28105, United States

Location

Piedmont Ear, Nose & Throat Associates, PA

Winston-Salem, North Carolina, 27103, United States

Location

UC Health Otolaryngology-Head and Neck Surgery

Cincinnati, Ohio, 45267, United States

Location

Department of Otolaryngology-Head and Neck Surgery, Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Carolina Ear, Nose & Throat Clinic/CENTRI Inc.

Orangeburg, South Carolina, 29118, United States

Location

Spartanburg/Greer ENT & Allergy

Spartanburg, South Carolina, 29303, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232-8605, United States

Location

Fort Worth ENT

Fort Worth, Texas, 76109, United States

Location

ENT Associates of Texas

McKinney, Texas, 75070, United States

Location

Alamo ENT Associates

San Antonio, Texas, 45227, United States

Location

Chrysalis Clinical Research

St. George, Utah, 84790, United States

Location

Eastern Virginia Medical School Department of Otolatyngology

Norfolk, Virginia, 23507, United States

Location

Advanced Otolaryngology, P.C. DBA Richmond ENT

Richmond, Virginia, 23235, United States

Location

HNO Praxis - Marianne Grohe

Cologne, 51061, Germany

Location

Universitätsklinikum Carl Gustav Carus Dresden

Dresden, 01307, Germany

Location

HNO - Praxis Göttingen

Göttingen, 37073, Germany

Location

HNO Praxis am Necker

Heidelberg, 69120, Germany

Location

HNO-Gemeinschaftspraxis

Heidelberg, 69126, Germany

Location

Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital

Jena, 07747, Germany

Location

Universitätsklinikum Mannheim Klinik für Otorhinolaryngologie, Kopf- und Halschirurgie

Mannheim, 68167, Germany

Location

Klinikum der Universitaet Muenchen

München, 81377, Germany

Location

Centrum Medyczne Kwiatowa

Bydgoszcz, 85-047, Poland

Location

Centrum Medyczne ZDROWA

Krakow, 31-216, Poland

Location

Centrum Medyczne PROMED

Krakow, 31-411, Poland

Location

MT Medic Specjalistyczna Pralctyka Lekarska Tomasz Stapiński

Krosno, 38-400, Poland

Location

University Hospitals Birmingham NHS Foundation Trust

Birmingham, B15 2TH, United Kingdom

Location

NHS Tayside

Dundee, DD1 9SY, United Kingdom

Location

University Hospitals of Leicester NHS Trust

Leicester, LE1 5WW, United Kingdom

Location

Norfolk and Norwich University Hospitals NHS Trust

Norwich, NR47UY, United Kingdom

Location

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, S10 2JF, United Kingdom

Location

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Medical Information
• Organization: Otonomy, Inc.

medinfo@otonomy.com

+1 844-686-4636

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled, multicenter

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: April 2, 2021
• Study Start: March 22, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: January 6, 2023
• Results First Posted: January 6, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (5); PL (4); DE (8); US (31)