OTO-313 in Subjects With Unilateral Subjective Tinnitus
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04829214 |
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Recruitment Status :
Recruiting
First Posted : April 2, 2021
Last Update Posted : June 11, 2021
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Sponsor:
Otonomy, Inc.
Information provided by (Responsible Party):
Otonomy, Inc.
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Subjective Tinnitus | Drug: OTO-313 Drug: Placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 140 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Randomized, double-blind, placebo-controlled, multicenter |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | March 22, 2021 |
| Estimated Primary Completion Date : | June 2022 |
| Estimated Study Completion Date : | August 2022 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: OTO-313 |
Drug: OTO-313
Single intratympanic injection |
| Placebo Comparator: Placebo |
Drug: Placebo
Single intratympanic injection |
Primary Outcome Measures :
- Change from Baseline in Tinnitus Functional Index (TFI) [ Time Frame: Week 4, Week 8 ]The TFI is a validated, 25-item questionnaire; index score from 0 to 100; higher scores indicate a greater problem with tinnitus
Secondary Outcome Measures :
- Daily Tinnitus Loudness [ Time Frame: Start of Lead-in (2 weeks before Baseline) to end of study (Week 16) ]Numerical rating scale from 0 (No Tinnitus) to 10 (Extremely Loud Tinnitus) collected every day
- Daily Tinnitus Annoyance [ Time Frame: Start of Lead-in (2 weeks before Baseline) to end of study (Week 16) ]Numerical rating scale from 0 (Not Annoying) to 10 (Extremely Annoying) collected every day
- Patient Global Impression of Change [ Time Frame: Week 4, Week 8, Week 12, Week 16 ]Change in overall tinnitus status as perceived by the subject
Other Outcome Measures:
- Treatment Emergent Adverse Events [ Time Frame: Reported or observed during or after dosing (Baseline) up to end of study (16 Weeks) ]An adverse event (AE) is any unfavorable and unintended diagnosis, symptom, sign, syndrome or disease which occurs during the study, having been absent at baseline, or, if present at baseline, appears to worsen. Treatment emergent means it started during or after dosing.
- Audiometry [ Time Frame: Screening, after dosing (Baseline) up to end of study (16 Weeks) ]Hearing function - clinically significant adverse change from Baseline
- Otoscopic Examinations [ Time Frame: After dosing (Baseline) up to end of study (16 Weeks) ]Ear examination - clinically significant adverse change from Baseline
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04829214
Contacts
| Contact: Clinical Study Manager | otonomyclinicaltrials@otonomy.com |
Locations
| United States, California | |
| Central California Clinical Research | Recruiting |
| Fresno, California, United States, 93720 | |
| Contact: Aimee Martinez 559-432-3303 ext 206 amartinez@ccent.com | |
| Principal Investigator: Brent Lanier, MD | |
| United States, Colorado | |
| Colorado ENT & Allergy | Recruiting |
| Colorado Springs, Colorado, United States, 80923 | |
| Contact: Monica Davis 719-867-7804 mdavis@coloradoent.com | |
| Contact 719-867-7800 | |
| Principal Investigator: Bryan M Davis, MD | |
| United States, Florida | |
| ENT and Allergy Associates of FL | Recruiting |
| Boynton Beach, Florida, United States, 33426 | |
| Contact: Amal El Kalimi-Short 561-737-8584 amal@lightent.com | |
| Principal Investigator: Joshua P Light, MD | |
| ENT and Allergy Associates of Florida, LLC | Recruiting |
| Delray Beach, Florida, United States, 33484 | |
| Contact: O. Sandy DiBattista 561-939-0186 oadibattista@entaaf.com | |
| Principal Investigator: Mark Widick, MD | |
| Ear Research Foundation | Recruiting |
| Sarasota, Florida, United States, 34239 | |
| Contact 941-556-4264 | |
| Principal Investigator: Herbert Silverstein, MD | |
| United States, Kentucky | |
| Advanced ENT and Allergy, PLLC | Recruiting |
| Louisville, Kentucky, United States, 40220 | |
| Contact: Rhonda Dase 502-893-0159 ext 1184 rdase@advancedentandallergy.com | |
| Principal Investigator: Amy Ingram, MD | |
| United States, Louisiana | |
| Tandem Clinical Research | Recruiting |
| Marrero, Louisiana, United States, 70072 | |
| Contact: Kristen Clinton 504-934-8424 Kclinton@tandemclinicalresearch.com | |
| Principal Investigator: Adil Fatakia, MD, MBA | |
| United States, New York | |
| Dent Neurosciences Research Center | Recruiting |
| Amherst, New York, United States, 14226 | |
| Contact: Jennifer Cox 716-250-7002 jcox@dentinstitute.com | |
| Principal Investigator: Lixin Zhang, MD, PhD | |
| United States, North Carolina | |
| Piedmont Ear, Nose & Throat Associates, PA | Recruiting |
| Winston-Salem, North Carolina, United States, 27103 | |
| Contact: Jessica Mack-Gill 336-768-3361 jmack@piedmontent.com | |
| Principal Investigator: Kenneth S Maxwell, MD | |
| United States, South Carolina | |
| Carolina Ear, Nose & Throat Clinic/CENTRI Inc. | Recruiting |
| Orangeburg, South Carolina, United States, 29118 | |
| Contact: Simone Ansley 803-870-8770 sansley700@gmail.com | |
| Principal Investigator: John F Ansley, MD | |
| Spartanburg/Greer ENT & Allergy | Recruiting |
| Spartanburg, South Carolina, United States, 29303 | |
| Contact: Joe Carey 864-278-1429 jcarey@spartanburgent.com | |
| Principal Investigator: Erik D. Steiniger, MD | |
| United States, Utah | |
| Chrysalis Clinical Research | Recruiting |
| Saint George, Utah, United States, 84790 | |
| Contact: Rian Farr 435-656-1704 rfarr@sgccr.com | |
| Principal Investigator: G. Paul Doxey, MD | |
Sponsors and Collaborators
Otonomy, Inc.
| Responsible Party: | Otonomy, Inc. |
| ClinicalTrials.gov Identifier: | NCT04829214 |
| Other Study ID Numbers: |
OTO-313-201 |
| First Posted: | April 2, 2021 Key Record Dates |
| Last Update Posted: | June 11, 2021 |
| Last Verified: | May 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Otonomy, Inc.:
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intratympanic injection IT injection gacyclidine tinnitus |
Additional relevant MeSH terms:
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Tinnitus Hearing Disorders Ear Diseases Otorhinolaryngologic Diseases |
Sensation Disorders Neurologic Manifestations Nervous System Diseases |