OTO-313 in Subjects With Unilateral Subjective Tinnitus

Subjective Tinnitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04829214
• Other study ID #: OTO-313-201
• Status: Completed
• Phase: Phase 2
• Start date: March 22, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: December 2022
• Source: Otonomy, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Subjective Tinnitus
• Tinnitus

Intervention

Drug:
• OTO-313
Single intratympanic injection
• Placebo
Single intratympanic injection

Locations

Country	Name	City	State
Germany	Universitätsklinikum Carl Gustav Carus Dresden	Dresden
Germany	HNO - Praxis Göttingen	Göttingen
Germany	HNO Praxis am Necker	Heidelberg
Germany	HNO-Gemeinschaftspraxis	Heidelberg
Germany	Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital	Jena
Germany	HNO Praxis - Marianne Grohe	Köln
Germany	Universitätsklinikum Mannheim Klinik für Otorhinolaryngologie, Kopf- und Halschirurgie	Mannheim
Germany	Klinikum der Universitaet Muenchen	Muenchen
Poland	Centrum Medyczne Kwiatowa	Bydgoszcz
Poland	Centrum Medyczne PROMED	Kraków
Poland	Centrum Medyczne ZDROWA	Kraków
Poland	MT Medic Specjalistyczna Pralctyka Lekarska Tomasz Stapinski	Krosno
United Kingdom	University Hospitals Birmingham NHS Foundation Trust	Birmingham
United Kingdom	NHS Tayside	Dundee
United Kingdom	University Hospitals of Leicester NHS Trust	Leicester
United Kingdom	Norfolk and Norwich University Hospitals NHS Trust	Norwich
United Kingdom	Sheffield Teaching Hospitals NHS Foundation Trust	Sheffield
United States	Dent Neurosciences Research Center	Amherst	New York
United States	University of Colorado, Department of Otolaryngology	Aurora	Colorado
United States	ENT and Allergy Associates of FL	Boynton Beach	Florida
United States	Department of Otolaryngology-Head and Neck Surgery, Medical University of South Carolina	Charleston	South Carolina
United States	ChicagoENT	Chicago	Illinois
United States	Rush University Medical Center	Chicago	Illinois
United States	UC Health Otolaryngology-Head and Neck Surgery	Cincinnati	Ohio
United States	Colorado ENT & Allergy	Colorado Springs	Colorado
United States	ENT and Allergy Associates of Florida, LLC	Delray Beach	Florida
United States	Fort Worth ENT	Fort Worth	Texas
United States	Central California Clinical Research	Fresno	California
United States	Research Centers of America	Hollywood	Florida
United States	Dartmouth-Hitchcock Medical Center/Mary Hitchcock Memorial Hospital	Lebanon	New Hampshire
United States	Advanced ENT and Allergy, PLLC	Louisville	Kentucky
United States	Kentuckian Ear, Nose & Throat	Louisville	Kentucky
United States	Tandem Clinical Research	Marrero	Louisiana
United States	Charlotte Eye Ear Nose & Throat Associates, P.A.	Matthews	North Carolina
United States	ENT Associates of Texas	McKinney	Texas
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Eastern Virginia Medical School Department of Otolatyngology	Norfolk	Virginia
United States	Carolina Ear, Nose & Throat Clinic/CENTRI Inc.	Orangeburg	South Carolina
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	Advanced Otolaryngology, P.C. DBA Richmond ENT	Richmond	Virginia
United States	Chrysalis Clinical Research	Saint George	Utah
United States	Center for Specialized Medicine, Department of Otolaryngology-Head and Neck Surgery	Saint Louis	Missouri
United States	Alamo ENT Associates	San Antonio	Texas
United States	Ear Research Foundation	Sarasota	Florida
United States	Spartanburg/Greer ENT & Allergy	Spartanburg	South Carolina
United States	Breathe Clear Institute	Torrance	California
United States	Piedmont Ear, Nose & Throat Associates, PA	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Otonomy, Inc.

Countries where clinical trial is conducted

United States,  Germany,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Primary	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	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.
Secondary	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
Secondary	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