Back to resultsOTO-313 in Subjects With Unilateral Subjective Tinnitus
Primary Purpose
Subjective Tinnitus
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
OTO-313
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Subjective Tinnitus focused on measuring intratympanic injection, IT injection, gacyclidine, 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.
Sites / Locations
- Central California Clinical Research
- Breathe Clear Institute
- University of Colorado, Department of Otolaryngology
- Colorado ENT & Allergy
- ENT and Allergy Associates of FL
- ENT and Allergy Associates of Florida, LLC
- Research Centers of America
- ENT and Allergy Associates of Florida, LLC
- ENT and Allergy Associates of Florida, LLC
- Ear Research Foundation
- Rush University Medical Center
- ChicagoENT
- Kentuckian Ear, Nose & Throat
- Advanced ENT and Allergy, PLLC
- Tandem Clinical Research
- Center for Specialized Medicine, Department of Otolaryngology-Head and Neck Surgery
- Dartmouth-Hitchcock Medical Center/Mary Hitchcock Memorial Hospital
- Dent Neurosciences Research Center
- Charlotte Eye Ear Nose & Throat Associates, P.A.
- Piedmont Ear, Nose & Throat Associates, PA
- UC Health Otolaryngology-Head and Neck Surgery
- Department of Otolaryngology-Head and Neck Surgery, Medical University of South Carolina
- Carolina Ear, Nose & Throat Clinic/CENTRI Inc.
- Spartanburg/Greer ENT & Allergy
- Vanderbilt University Medical Center
- Fort Worth ENT
- ENT Associates of Texas
- Alamo ENT Associates
- Chrysalis Clinical Research
- Eastern Virginia Medical School Department of Otolatyngology
- Advanced Otolaryngology, P.C. DBA Richmond ENT
- Universitätsklinikum Carl Gustav Carus Dresden
- HNO - Praxis Göttingen
- HNO Praxis am Necker
- HNO-Gemeinschaftspraxis
- Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital
- HNO Praxis - Marianne Grohe
- Universitätsklinikum Mannheim Klinik für Otorhinolaryngologie, Kopf- und Halschirurgie
- Klinikum der Universitaet Muenchen
- Centrum Medyczne Kwiatowa
- Centrum Medyczne ZDROWA
- Centrum Medyczne PROMED
- MT Medic Specjalistyczna Pralctyka Lekarska Tomasz Stapiński
- University Hospitals Birmingham NHS Foundation Trust
- NHS Tayside
- University Hospitals of Leicester NHS Trust
- Norfolk and Norwich University Hospitals NHS Trust
- Sheffield Teaching Hospitals NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
OTO-313
Placebo
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04829214
Brief Title
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
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
March 22, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otonomy, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subjective Tinnitus
Keywords
intratympanic injection, IT injection, gacyclidine, tinnitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Randomized, double-blind, placebo-controlled, multicenter
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
153 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OTO-313
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
OTO-313
Intervention Description
Single intratympanic injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Single intratympanic injection
Primary Outcome Measure Information:
Title
Percentage of Tinnitus Functional Index (TFI) Responders at Weeks 4 and at Week 8
Description
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.
Time Frame
Week 4 and Week 8 (both had to meet criterion for the subject to be considered a "responder")
Secondary Outcome Measure Information:
Title
Change From Baseline in Daily Tinnitus Loudness at Week 8
Description
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.
Time Frame
The average is calculated for the Baseline and for each study week. Reported here is the change from Baseline to Week 8.
Title
Change From Baseline in Daily Tinnitus Annoyance at Week 8
Description
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.
Time Frame
The average is calculated for the Baseline and for each study week. Reported here is the change from Baseline to Week 8
Title
Patient Global Impression of Change at Week 8
Description
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.
Time Frame
Week 8 reported here
Other Pre-specified Outcome Measures:
Title
Otoscopic Examinations - Presence of Perforation in the Treated Ear at Week 16 (Final Visit)
Description
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.
Time Frame
After dosing (Baseline) up to end of study (16 Weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Central California Clinical Research
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Breathe Clear Institute
City
Torrance
State/Province
California
ZIP/Postal Code
90503
Country
United States
Facility Name
University of Colorado, Department of Otolaryngology
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Colorado ENT & Allergy
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80923
Country
United States
Facility Name
ENT and Allergy Associates of FL
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33426
Country
United States
Facility Name
ENT and Allergy Associates of Florida, LLC
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33484
Country
United States
Facility Name
Research Centers of America
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
ENT and Allergy Associates of Florida, LLC
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
ENT and Allergy Associates of Florida, LLC
City
Port Saint Lucie
State/Province
Florida
ZIP/Postal Code
34952
Country
United States
Facility Name
Ear Research Foundation
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
ChicagoENT
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
Kentuckian Ear, Nose & Throat
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40205
Country
United States
Facility Name
Advanced ENT and Allergy, PLLC
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40220
Country
United States
Facility Name
Tandem Clinical Research
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Facility Name
Center for Specialized Medicine, Department of Otolaryngology-Head and Neck Surgery
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center/Mary Hitchcock Memorial Hospital
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Dent Neurosciences Research Center
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
Country
United States
Facility Name
Charlotte Eye Ear Nose & Throat Associates, P.A.
City
Matthews
State/Province
North Carolina
ZIP/Postal Code
28105
Country
United States
Facility Name
Piedmont Ear, Nose & Throat Associates, PA
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
UC Health Otolaryngology-Head and Neck Surgery
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Department of Otolaryngology-Head and Neck Surgery, Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Carolina Ear, Nose & Throat Clinic/CENTRI Inc.
City
Orangeburg
State/Province
South Carolina
ZIP/Postal Code
29118
Country
United States
Facility Name
Spartanburg/Greer ENT & Allergy
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-8605
Country
United States
Facility Name
Fort Worth ENT
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76109
Country
United States
Facility Name
ENT Associates of Texas
City
McKinney
State/Province
Texas
ZIP/Postal Code
75070
Country
United States
Facility Name
Alamo ENT Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
45227
Country
United States
Facility Name
Chrysalis Clinical Research
City
Saint George
State/Province
Utah
ZIP/Postal Code
84790
Country
United States
Facility Name
Eastern Virginia Medical School Department of Otolatyngology
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Advanced Otolaryngology, P.C. DBA Richmond ENT
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23235
Country
United States
Facility Name
Universitätsklinikum Carl Gustav Carus Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
HNO - Praxis Göttingen
City
Göttingen
ZIP/Postal Code
37073
Country
Germany
Facility Name
HNO Praxis am Necker
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
HNO-Gemeinschaftspraxis
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Facility Name
Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital
City
Jena
ZIP/Postal Code
07747
Country
Germany
Facility Name
HNO Praxis - Marianne Grohe
City
Köln
ZIP/Postal Code
51061
Country
Germany
Facility Name
Universitätsklinikum Mannheim Klinik für Otorhinolaryngologie, Kopf- und Halschirurgie
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Klinikum der Universitaet Muenchen
City
Muenchen
ZIP/Postal Code
81377
Country
Germany
Facility Name
Centrum Medyczne Kwiatowa
City
Bydgoszcz
ZIP/Postal Code
85-047
Country
Poland
Facility Name
Centrum Medyczne ZDROWA
City
Kraków
ZIP/Postal Code
31-216
Country
Poland
Facility Name
Centrum Medyczne PROMED
City
Kraków
ZIP/Postal Code
31-411
Country
Poland
Facility Name
MT Medic Specjalistyczna Pralctyka Lekarska Tomasz Stapiński
City
Krosno
ZIP/Postal Code
38-400
Country
Poland
Facility Name
University Hospitals Birmingham NHS Foundation Trust
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
NHS Tayside
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
University Hospitals of Leicester NHS Trust
City
Leicester
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Norfolk and Norwich University Hospitals NHS Trust
City
Norwich
ZIP/Postal Code
NR47UY
Country
United Kingdom
Facility Name
Sheffield Teaching Hospitals NHS Foundation Trust
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
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OTO-313 in Subjects With Unilateral Subjective Tinnitus
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