Clinical trial NCT04829214: OTO-313 in Subjects With Unilateral Subjective Tinnitus
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Subjective Tinnitus
Keywords: intratympanic injection
IT injection
gacyclidine
tinnitus
Lead sponsor: Otonomy, Inc.
Sponsor class: INDUSTRY
First posted: 2021-04-02
Enrollment: 153
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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Tinnitus Functional Index (TFI) Responders at Weeks 4 and at Week 8
timeFrame: Week 4 and Week 8 (both had to meet criterion for the subject to be considered a "responder")
Secondary outcomes:
measure: Change From Baseline in Daily Tinnitus Loudness at Week 8
timeFrame: The average is calculated for the Baseline and for each study week. Reported here is the change from Baseline to Week 8.
measure: Change From Baseline in Daily Tinnitus Annoyance at Week 8
timeFrame: The average is calculated for the Baseline and for each study week. Reported here is the change from Baseline to Week 8
measure: Patient Global Impression of Change at Week 8
timeFrame: Week 8 reported here
Other outcomes:
measure: Otoscopic Examinations - Presence of Perforation in the Treated Ear at Week 16 (Final Visit)
timeFrame: After dosing (Baseline) up to end of study (16 Weeks)
Locations:
city: Fresno
country: United States
facility: Central California Clinical Research
state: California
city: Torrance
country: United States
facility: Breathe Clear Institute
state: California
city: Aurora
country: United States
facility: University of Colorado, Department of Otolaryngology
state: Colorado
city: Colorado Springs
country: United States
facility: Colorado ENT & Allergy
state: Colorado
city: Boynton Beach
country: United States
facility: ENT and Allergy Associates of FL
state: Florida
city: Delray Beach
country: United States
facility: ENT and Allergy Associates of Florida, LLC
state: Florida
city: Hollywood
country: United States
facility: Research Centers of America
state: Florida
city: Plantation
country: United States
facility: ENT and Allergy Associates of Florida, LLC
state: Florida
city: Port Saint Lucie
country: United States
facility: ENT and Allergy Associates of Florida, LLC
state: Florida
city: Sarasota
country: United States
facility: Ear Research Foundation
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Chicago
country: United States
facility: ChicagoENT
state: Illinois
city: Louisville
country: United States
facility: Kentuckian Ear, Nose & Throat
state: Kentucky
city: Louisville
country: United States
facility: Advanced ENT and Allergy, PLLC
state: Kentucky
city: Marrero
country: United States
facility: Tandem Clinical Research
state: Louisiana
city: Saint Louis
country: United States
facility: Center for Specialized Medicine, Department of Otolaryngology-Head and Neck Surgery
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center/Mary Hitchcock Memorial Hospital
state: New Hampshire
city: Amherst
country: United States
facility: Dent Neurosciences Research Center
state: New York
city: Matthews
country: United States
facility: Charlotte Eye Ear Nose & Throat Associates, P.A.
state: North Carolina
city: Winston-Salem
country: United States
facility: Piedmont Ear, Nose & Throat Associates, PA
state: North Carolina
city: Cincinnati
country: United States
facility: UC Health Otolaryngology-Head and Neck Surgery
state: Ohio
city: Charleston
country: United States
facility: Department of Otolaryngology-Head and Neck Surgery, Medical University of South Carolina
state: South Carolina
city: Orangeburg
country: United States
facility: Carolina Ear, Nose & Throat Clinic/CENTRI Inc.
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg/Greer ENT & Allergy
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Fort Worth
country: United States
facility: Fort Worth ENT
state: Texas
city: McKinney
country: United States
facility: ENT Associates of Texas
state: Texas
city: San Antonio
country: United States
facility: Alamo ENT Associates
state: Texas
city: Saint George
country: United States
facility: Chrysalis Clinical Research
state: Utah
city: Norfolk
country: United States
facility: Eastern Virginia Medical School Department of Otolatyngology
state: Virginia
city: Richmond
country: United States
facility: Advanced Otolaryngology, P.C. DBA Richmond ENT
state: Virginia
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus Dresden
city: Göttingen
country: Germany
facility: HNO - Praxis Göttingen
city: Heidelberg
country: Germany
facility: HNO Praxis am Necker
city: Heidelberg
country: Germany
facility: HNO-Gemeinschaftspraxis
city: Jena
country: Germany
facility: Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital
city: Köln
country: Germany
facility: HNO Praxis - Marianne Grohe
city: Mannheim
country: Germany
facility: Universitätsklinikum Mannheim Klinik für Otorhinolaryngologie, Kopf- und Halschirurgie
city: Muenchen
country: Germany
facility: Klinikum der Universitaet Muenchen
city: Bydgoszcz
country: Poland
facility: Centrum Medyczne Kwiatowa
city: Kraków
country: Poland
facility: Centrum Medyczne ZDROWA
city: Kraków
country: Poland
facility: Centrum Medyczne PROMED
city: Krosno
country: Poland
facility: MT Medic Specjalistyczna Pralctyka Lekarska Tomasz Stapiński
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust
city: Dundee
country: United Kingdom
facility: NHS Tayside
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester NHS Trust
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospitals NHS Trust
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals NHS Foundation Trust
Study officials:
References: