Subjective TinnitusPhase 2NCT04829214
OTO-313 in Subjects With Unilateral Subjective Tinnitus
A Phase 2 study testing OTO-313 in people with Subjective Tinnitus, run by Otonomy, Inc. at 48 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Subjective Tinnitus
- What is being tested?
- OTO-313
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 153 participants
- Where
- 48 sitesin 4 countries
- Study dates
- 22 Mar 2021to 30 Jun 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
48 sites in 4 countries.
48 sites in 4 countries
United States31 sites
Dent Neurosciences Research Center
Amherst, New York, 14226
University of Colorado, Department of Otolaryngology
Aurora, Colorado, 80045
ENT and Allergy Associates of FL
Boynton Beach, Florida, 33426
Department of Otolaryngology-Head and Neck Surgery, Medical University of South Carolina
Charleston, South Carolina, 29425
Rush University Medical Center
Chicago, Illinois, 60612
ChicagoENT
Chicago, Illinois, 60657
UC Health Otolaryngology-Head and Neck Surgery
Cincinnati, Ohio, 45267
Colorado ENT & Allergy
Colorado Springs, Colorado, 80923
ENT and Allergy Associates of Florida, LLC
Delray Beach, Florida, 33484
Fort Worth ENT
Fort Worth, Texas, 76109
Central California Clinical Research
Fresno, California, 93720
Research Centers of America
Hollywood, Florida, 33024
Dartmouth-Hitchcock Medical Center/Mary Hitchcock Memorial Hospital
Lebanon, New Hampshire, 03756
Kentuckian Ear, Nose & Throat
Louisville, Kentucky, 40205
Advanced ENT and Allergy, PLLC
Louisville, Kentucky, 40220
Tandem Clinical Research
Marrero, Louisiana, 70072
Charlotte Eye Ear Nose & Throat Associates, P.A.
Matthews, North Carolina, 28105
ENT Associates of Texas
McKinney, Texas, 75070
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-8605
Eastern Virginia Medical School Department of Otolatyngology
Norfolk, Virginia, 23507
Carolina Ear, Nose & Throat Clinic/CENTRI Inc.
Orangeburg, South Carolina, 29118
ENT and Allergy Associates of Florida, LLC
Plantation, Florida, 33324
ENT and Allergy Associates of Florida, LLC
Port Saint Lucie, Florida, 34952
Advanced Otolaryngology, P.C. DBA Richmond ENT
Richmond, Virginia, 23235
Alamo ENT Associates
San Antonio, Texas, 45227
Ear Research Foundation
Sarasota, Florida, 34239
Spartanburg/Greer ENT & Allergy
Spartanburg, South Carolina, 29303
Center for Specialized Medicine, Department of Otolaryngology-Head and Neck Surgery
St Louis, Missouri, 63104
Chrysalis Clinical Research
St. George, Utah, 84790
Breathe Clear Institute
Torrance, California, 90503
Piedmont Ear, Nose & Throat Associates, PA
Winston-Salem, North Carolina, 27103
Germany8 sites
HNO Praxis - Marianne Grohe
Cologne, 51061
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, 01307
HNO - Praxis Göttingen
Göttingen, 37073
HNO Praxis am Necker
Heidelberg, 69120
HNO-Gemeinschaftspraxis
Heidelberg, 69126
Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital
Jena, 07747
Universitätsklinikum Mannheim Klinik für Otorhinolaryngologie, Kopf- und Halschirurgie
Mannheim, 68167
Klinikum der Universitaet Muenchen
München, 81377
United Kingdom5 sites
University Hospitals Birmingham NHS Foundation Trust
Birmingham, B15 2TH
NHS Tayside
Dundee, DD1 9SY
University Hospitals of Leicester NHS Trust
Leicester, LE1 5WW
Norfolk and Norwich University Hospitals NHS Trust
Norwich, NR47UY
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, S10 2JF
Poland4 sites
Centrum Medyczne Kwiatowa
Bydgoszcz, 85-047
Centrum Medyczne ZDROWA
Krakow, 31-216
Centrum Medyczne PROMED
Krakow, 31-411
MT Medic Specjalistyczna Pralctyka Lekarska Tomasz Stapiński
Krosno, 38-400
About this study
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
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.
- Conditions
- Subjective Tinnitus
- Being tested
- OTO-313, Placebo
- Keywords
- intratympanic injection, IT injection, gacyclidine, tinnitus
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OTO-313Drug
Single intratympanic injection
PlaceboDrug
Single intratympanic injection
| Study group | Role | What they receive |
|---|---|---|
| OTO-313 | Experimental | Not described Receives: Drug: OTO-313 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 4 and Week 8 (both had to meet criterion for the subject to be considered a "responder")
Secondary outcomes (3)
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.
Measured: The average is calculated for the Baseline and for each study week. Reported here is the change from Baseline to Week 8.
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.
Measured: 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.
Measured: Week 8 reported here
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study start22 Mar 2021
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Subjective TinnitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, placebo-controlled, multicenter
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otonomy, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04829214
- Sponsor's protocol ID
- OTO-313-201
- Status last verified
- Dec 2022
- First submitted
- 29 Mar 2021
- Last updated
- 6 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04829214
- Acronym / sponsor ID
- OTO-313-201
- Conditions
- Subjective Tinnitus
- Keywords
- intratympanic injection, IT injection, gacyclidine, tinnitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Otonomy, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Mar 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 2 Apr 2021 (actual)
- Results
- Posted 6 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind, placebo-controlled, multicenter
| Arm | Type | Receives |
|---|---|---|
| OTO-313 | Experimental | Drug: OTO-313 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OTO-313Single intratympanic injection | Drug | OTO-313 |
| PlaceboSingle intratympanic injection | Drug | Placebo |
Primary outcome
Percentage of Tinnitus Functional Index (TFI) Responders at Weeks 4 and at Week 8
Time frame: Week 4 and Week 8 (both had to meet criterion for the subject to be considered a "responder")
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.
3 secondary outcomes
Change From Baseline in Daily Tinnitus Loudness at Week 8
Time frame: The average is calculated for the Baseline and for each study week. Reported here is the change from Baseline to Week 8.
Change From Baseline in Daily Tinnitus Annoyance at Week 8
Time frame: 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
Time frame: Week 8 reported here
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
48 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OTO-313 in people with Subjective Tinnitus, run by Otonomy, Inc. at 48 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in United States, Germany, United Kingdom, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Tinnitus Functional Index (TFI) Responders at Weeks 4 and at Week 8 (time frame: Week 4 and Week 8 (both had to meet criterion for the subject to be considered a "responder")). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2023.