Clinical trial NCT03918109: OTO-313 in Subjects With Subjective Tinnitus
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Tinnitus, Subjective
Keywords: tinnitus, intratympanic injection, gacyclidine
Lead sponsor: Otonomy, Inc.
Sponsor class: INDUSTRY
First posted: 2019-04-17
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blind, placebo-controlled, multicenter
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Audiometry - Pure Tone Average Done Over 1000, 2000 and 4000 Hertz (HZ)
timeFrame: Up to end of study (Part A - Day 29 [4 weeks after dosing]), (Part B - Day 57 [8 weeks after dosing])
measure: 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)).
timeFrame: Up to end of study (Part A - Day 29 [4 weeks after the injection], Part B - Day 57 [8 weeks after the injection])
Secondary outcomes:
Other outcomes:
measure: Change From Baseline in Tinnitus Functional Index (TFI)
timeFrame: Up to the End of Study Visit (Part A - Day 29 [4 weeks after the injection]), (Part B - Day 57 [8 weeks after injection])
measure: Patient Global Impression of Change (PGIC)
timeFrame: Measured at the end of study visit (Part A - Day 29 [4 weeks after injection]), (Part B - Day 57 [8 weeks after injection]).
Locations:
city: Los Angeles
country: United States
facility: House Clinic
state: California
city: San Diego
country: United States
facility: California Head & Neck Specialists
state: California
city: Colorado Springs
country: United States
facility: Colorado ENT and Allergy
state: Colorado
city: Sarasota
country: United States
facility: Silverstein Institute/Ear Research Foundation
state: Florida
city: Chicago
country: United States
facility: ChicagoENT
state: Illinois
city: Louisville
country: United States
facility: Advanced ENT and Allergy
state: Kentucky
city: Marrero
country: United States
facility: Tandem Clinical Research, LLC
state: Louisiana
city: Berkeley Heights
country: United States
facility: Summit Medical Group
state: New Jersey
city: Amherst
country: United States
facility: Dent Neurosciences Research Center
state: New York
city: New Hyde Park
country: United States
facility: Northwell Health, Hearing & Speech Center
state: New York
city: White Plains
country: United States
facility: Northwell Health at ENT and Allergy Associates
state: New York
city: Charlotte
country: United States
facility: Charlotte Eye Ear Nose & Throat Associates
state: North Carolina
city: Winston-Salem
country: United States
facility: Piedmont Ear, Nose, and Throat Associates
state: North Carolina
city: San Antonio
country: United States
facility: Worldwide Clinical Trials
state: Texas
city: Saint George
country: United States
facility: Chrysalis Clinical Research
state: Utah
city: Morgantown
country: United States
facility: WVU Medicine
state: West Virginia
Study officials:
References: