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

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.

Study Overview

• Status: Completed
• Conditions: Subjective Tinnitus
• Intervention / Treatment: Drug: OTO-313; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 153
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Single intratympanic injection
Experimental: OTO-313	Drug: OTO-313; Single intratympanic injection

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Otoscopic Examinations - Presence of Perforation in the Treated Ear at Week 16 (Final Visit)	Ear examinations were done at every visit. One of the important safety endpoints is an observation of a perforation in the ear drum that did not heal properly after the injection. Reported here are the Week 16 (final visit) results.	After dosing (Baseline) up to end of study (16 Weeks)

Collaborators and Investigators

• Sponsor: Otonomy, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2021
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: March 29, 2021
• First Submitted That Met QC Criteria: March 31, 2021
• First Posted (Actual): April 2, 2021

Study Record Updates

• Last Update Posted (Estimate): January 6, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: tinnitus; intratympanic injection; IT injection; gacyclidine
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Tinnitus
• Other Study ID Numbers: OTO-313-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No