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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OTO-313 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OTO-313 | Drug | Single intratympanic injection |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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") |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central California Clinical Research | Fresno | California | 93720 | United States | ||
| Breathe Clear Institute |
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All subjects registered for this study signed an informed consent and entered a lead-in period. Following Lead-in, 153 subjects were randomized (=Full Analysis Set) and 151 subjects received study drug (=Safety Analysis Set). The most common reason for not being randomized was too low a score on the Tinnitus Functional Index (TFI)..
Overall, 56 clinical centers were approved in Germany, Poland, United States, and United Kingdom to conduct this study. Thirty-six centers enrolled subjects. First subject was randomized 04 May 2021; Last subject was randomized 21 February 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | OTO-313 | OTO-313: Single intratympanic 200 microliter injection of gacyclidine solution in medium chain triglycerides (0.16 mg/mL) |
| FG001 | Placebo | Placebo: Single intratympanic 200 microliter injection of medium chain triglycerides (OTO-313 vehicle) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Randomization |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 20, 2021 |
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Randomized, double-blind, placebo-controlled, multicenter
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| Drug |
Single intratympanic injection |
|
| 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 |
| 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 |
| Torrance |
| California |
| 90503 |
| United States |
| University of Colorado, Department of Otolaryngology | Aurora | Colorado | 80045 | United States |
| Colorado ENT & Allergy | Colorado Springs | Colorado | 80923 | United States |
| ENT and Allergy Associates of FL | Boynton Beach | Florida | 33426 | United States |
| ENT and Allergy Associates of Florida, LLC | Delray Beach | Florida | 33484 | United States |
| Research Centers of America | Hollywood | Florida | 33024 | United States |
| ENT and Allergy Associates of Florida, LLC | Plantation | Florida | 33324 | United States |
| ENT and Allergy Associates of Florida, LLC | Port Saint Lucie | Florida | 34952 | United States |
| Ear Research Foundation | Sarasota | Florida | 34239 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| ChicagoENT | Chicago | Illinois | 60657 | United States |
| Kentuckian Ear, Nose & Throat | Louisville | Kentucky | 40205 | United States |
| Advanced ENT and Allergy, PLLC | Louisville | Kentucky | 40220 | United States |
| Tandem Clinical Research | Marrero | Louisiana | 70072 | United States |
| Center for Specialized Medicine, Department of Otolaryngology-Head and Neck Surgery | St Louis | Missouri | 63104 | United States |
| Dartmouth-Hitchcock Medical Center/Mary Hitchcock Memorial Hospital | Lebanon | New Hampshire | 03756 | United States |
| Dent Neurosciences Research Center | Amherst | New York | 14226 | United States |
| Charlotte Eye Ear Nose & Throat Associates, P.A. | Matthews | North Carolina | 28105 | United States |
| Piedmont Ear, Nose & Throat Associates, PA | Winston-Salem | North Carolina | 27103 | United States |
| UC Health Otolaryngology-Head and Neck Surgery | Cincinnati | Ohio | 45267 | United States |
| Department of Otolaryngology-Head and Neck Surgery, Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Carolina Ear, Nose & Throat Clinic/CENTRI Inc. | Orangeburg | South Carolina | 29118 | United States |
| Spartanburg/Greer ENT & Allergy | Spartanburg | South Carolina | 29303 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232-8605 | United States |
| Fort Worth ENT | Fort Worth | Texas | 76109 | United States |
| ENT Associates of Texas | McKinney | Texas | 75070 | United States |
| Alamo ENT Associates | San Antonio | Texas | 45227 | United States |
| Chrysalis Clinical Research | St. George | Utah | 84790 | United States |
| Eastern Virginia Medical School Department of Otolatyngology | Norfolk | Virginia | 23507 | United States |
| Advanced Otolaryngology, P.C. DBA Richmond ENT | Richmond | Virginia | 23235 | United States |
| HNO Praxis - Marianne Grohe | Cologne | 51061 | Germany |
| Universitätsklinikum Carl Gustav Carus Dresden | Dresden | 01307 | Germany |
| HNO - Praxis Göttingen | Göttingen | 37073 | Germany |
| HNO Praxis am Necker | Heidelberg | 69120 | Germany |
| HNO-Gemeinschaftspraxis | Heidelberg | 69126 | Germany |
| Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital | Jena | 07747 | Germany |
| Universitätsklinikum Mannheim Klinik für Otorhinolaryngologie, Kopf- und Halschirurgie | Mannheim | 68167 | Germany |
| Klinikum der Universitaet Muenchen | München | 81377 | Germany |
| Centrum Medyczne Kwiatowa | Bydgoszcz | 85-047 | Poland |
| Centrum Medyczne ZDROWA | Krakow | 31-216 | Poland |
| Centrum Medyczne PROMED | Krakow | 31-411 | Poland |
| MT Medic Specjalistyczna Pralctyka Lekarska Tomasz Stapiński | Krosno | 38-400 | Poland |
| University Hospitals Birmingham NHS Foundation Trust | Birmingham | B15 2TH | United Kingdom |
| NHS Tayside | Dundee | DD1 9SY | United Kingdom |
| University Hospitals of Leicester NHS Trust | Leicester | LE1 5WW | United Kingdom |
| Norfolk and Norwich University Hospitals NHS Trust | Norwich | NR47UY | United Kingdom |
| Sheffield Teaching Hospitals NHS Foundation Trust | Sheffield | S10 2JF | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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| Follow-up and Efficacy Analysis |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | OTO-313 | OTO-313: Single intratympanic injection |
| BG001 | Placebo | Placebo: Single intratympanic injection |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Duration of Tinnitus | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | Week 4 and Week 8 (both had to meet criterion for the subject to be considered a "responder") |
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| 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. | Posted | Mean | Standard Deviation | units on a scale | The average is calculated for the Baseline and for each study week. Reported here is the change from Baseline to Week 8. |
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| 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. | Posted | Mean | Standard Deviation | units on a scale | The average is calculated for the Baseline and for each study week. Reported here is the change from Baseline to Week 8 |
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| 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. | Posted | Least Squares Mean | Standard Error | score on a scale | Week 8 reported here |
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| Other Pre-specified | 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. | Posted | Count of Participants | Participants | After dosing (Baseline) up to end of study (16 Weeks) |
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Adverse events were recorded as observed or reported during or after dosing up to the final visit (Week 16).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | OTO-313 Safety Analysis Set | Subjects randomized to OTO-313 and received a dose of OTO-313. | 0 | 77 | 2 | 77 | 23 | 77 |
| EG001 | Placebo Safety Analysis Set | Subjects randomized to placebo and received placebo. | 0 | 76 | 0 | 76 | 24 | 76 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arteriosclerosis | Vascular disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA (23.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Blood Potassium Increased | Investigations | MedDRA (23.1) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (23.1) | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA (23.1) | Non-systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA (23.1) | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA (23.1) | Non-systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA (23.1) | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA (23.1) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (23.1) | Non-systematic Assessment |
| |
| Viral Sinusitis | Infections and infestations | MedDRA (23.1) | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Information | Otonomy, Inc. | +1 844-686-4636 | medinfo@otonomy.com |
| Oct 13, 2022 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014012 | Tinnitus |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Poland |
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| United Kingdom |
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| Germany |
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| >6 to ≤12 months |
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