OTO-313 in Subjects With Subjective Tinnitus

Tinnitus, Subjective Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled Phase 1/2 Study of OTO-313 Given as a Single Intratympanic Injection in Subjects With Subjective Tinnitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03918109
• Other study ID #: 313-201901
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: April 4, 2019
• Est. completion date: May 29, 2020

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 evaluate the safety, tolerability, plasma pharmacokinetics (PK), and exploratory efficacy of OTO-313 administered as an intratympanic injection for the treatment of subjective tinnitus.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: May 29, 2020
• Est. primary completion date: May 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Subject has subjective unilateral tinnitus and is consistently aware of their tinnitus throughout much of the waking day.

• Subject is able to use the electronic 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, tinnitus resulting from traumatic head or neck injury, or tinnitus resulting from a tumor or stroke.

• Subject is pregnant or lactating.

• Subject has other clinically significant illness, medical condition or medical history at Screening or Baseline (Day 1) that, in the Investigator's opinion, would likely reduce the safety of study participation or compliance with study procedures.

Related Conditions & MeSH terms

• Tinnitus
• Tinnitus, Subjective

Intervention

Drug:
• OTO-313
single intratympanic injection of gacyclidine
• Placebo
single intratympanic injection of placebo

Locations

Country	Name	City	State
United States	Dent Neurosciences Research Center	Amherst	New York
United States	Summit Medical Group	Berkeley Heights	New Jersey
United States	Charlotte Eye Ear Nose & Throat Associates	Charlotte	North Carolina
United States	ChicagoENT	Chicago	Illinois
United States	Colorado ENT and Allergy	Colorado Springs	Colorado
United States	House Clinic	Los Angeles	California
United States	Advanced ENT and Allergy	Louisville	Kentucky
United States	Tandem Clinical Research, LLC	Marrero	Louisiana
United States	WVU Medicine	Morgantown	West Virginia
United States	Northwell Health, Hearing & Speech Center	New Hyde Park	New York
United States	Chrysalis Clinical Research	Saint George	Utah
United States	Worldwide Clinical Trials	San Antonio	Texas
United States	California Head & Neck Specialists	San Diego	California
United States	Silverstein Institute/Ear Research Foundation	Sarasota	Florida
United States	Northwell Health at ENT and Allergy Associates	White Plains	New York
United States	Piedmont Ear, Nose, and Throat Associates	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Otonomy, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change From Baseline in Tinnitus Functional Index (TFI)	Validated, 25-item questionnaire; index score from 0 to 100; a negative change indicates improvement. The 25 items of the TFI represent 8 subscales covering multiple domains of tinnitus severity: 1) Intrusive, 2) Sense of Control, 3) Cognitive, 4) Sleep, 5) Auditory, 6) Relaxation, 7) Quality of Life, and 8) Emotional. Subjects answer each TFI question by rating their experience over the past week. Each subscale has 3 questions with a response ranging from 0 (best response) to 10 (worst response) in regard to the impact of tinnitus in these different aspects of the subject's life. The highest raw score would be 250 and the lowest would be 0. The raw score is then divided by the total number of valid answers and that in turn is multiplied by 10 to give an overall score range from 0-100, with 0 representing no impact of tinnitus on their daily life and 100 representing complete impact of tinnitus on their daily life.	Up to the End of Study Visit (Part A - Day 29 [4 weeks after the injection]), (Part B - Day 57 [8 weeks after injection])
Other	Patient Global Impression of Change (PGIC)	Change in overall tinnitus status as perceived by the subject; this was a subject-reported outcome that evaluated the change in overall "global" tinnitus status as perceived by the subject. The subject was asked: "Since the beginning of the clinical study, how would you rate your tinnitus?".; The beginning of the clinical study in this context was the time prior to investigational product administration. The 7 response categories (and point scores) for the PGIC are: Very much improved = 3; Much improved = 2; Minimally improved = 1; Unchanged = 0; Minimally worse = -1; Much worse = -2; Very much worse = -3	Measured at the end of study visit (Part A - Day 29 [4 weeks after injection]), (Part B - Day 57 [8 weeks after injection]).
Primary	Audiometry - Pure Tone Average Done Over 1000, 2000 and 4000 Hertz (HZ)	Mean Change from Baseline to End of Study (baseline to Day 29 [4 weeks after dosing](Part A) or baseline to Day 57 [8 weeks after dosing] (Part B)). in Pure Tone Average Hearing Thresholds; a negative change indicates improvement.	Up to end of study (Part A - Day 29 [4 weeks after dosing]), (Part B - Day 57 [8 weeks after dosing])
Primary	Otoscopic Examination - Presence of Perforation in the Treated Ear at the End of Study Visit (Day 29 [4 Weeks After Dosing] (Part A) or Day 57 [8 Weeks After Dosing] (Part B)).	Ear examinations were done at every visit. One of the important safety endpoints was an observation of a perforation in the ear drum that did not heal properly after the injection.	Up to end of study (Part A - Day 29 [4 weeks after the injection], Part B - Day 57 [8 weeks after the injection])