OTO-313 for Tinnitus

Not currently recruiting at 54 trial locations

Overseen By John T Lanza, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Otonomy, Inc.

Disqualifiers: Pulsatile tinnitus, TMJ, Pregnancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 16

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the effectiveness of a treatment called OTO-313 for individuals with unilateral tinnitus, a ringing or buzzing sound in one ear. Researchers seek to determine if OTO-313 can reduce symptoms and ensure its safety. Participants will receive either the actual treatment or a placebo (a harmless, inactive substance) for comparison. Individuals who have recently started experiencing constant ringing in one ear, likely related to hearing issues or ear injury, might be a good fit. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that OTO-313 is generally safe and well-tolerated. In one study, four out of six patients experienced reduced tinnitus, and the treatment was considered safe overall. However, one case involved a small hole in the eardrum that did not heal properly after the injection. Another study confirmed that OTO-313, when administered as an ear injection, did not cause major safety concerns. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for tinnitus?

Researchers are excited about OTO-313 for unilateral subjective tinnitus because it offers a novel approach compared to existing treatments like sound therapy and medications such as antidepressants and anticonvulsants. Unlike the standard of care, which often focuses on masking the noise or addressing its psychological impact, OTO-313 is designed to be injected directly into the middle ear. This localized delivery targets the cochlea, potentially modulating the activity of nerve cells responsible for the phantom noises associated with tinnitus. This unique mechanism could lead to more direct and effective relief for patients suffering from this often debilitating condition.

What evidence suggests that OTO-313 might be an effective treatment for tinnitus?

Research has shown that OTO-313, which participants in this trial may receive, might help reduce tinnitus symptoms. In one study, people who received OTO-313 reported more relief from tinnitus than those who received a placebo, another treatment option in this trial with no active medicine. More participants felt their symptoms improved with OTO-313. It was also well-tolerated, meaning patients did not experience significant side effects. This suggests OTO-313 could be a helpful option for those with tinnitus in one ear. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

Inclusion Criteria

Subject is willing to comply with the protocol and attend all study visits.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intratympanic injection of OTO-313 or placebo

8 weeks

Weekly visits for assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

Final visit at Week 16

What Are the Treatments Tested in This Trial?

Interventions

• OTO-313
• Placebo

How Is the Trial Designed?

Group I: OTO-313 Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Otonomy, Inc.

Lead Sponsor

Trials

22

Recruited

3,100+

Published Research Related to This Trial

A single intratympanic injection of OTO-104, a sustained-release dexamethasone formulation, was found to be safe and well tolerated in 44 patients with unilateral Ménière's disease, with no significant impact on hearing function.

The 12 mg dose of OTO-104 resulted in a clinically meaningful reduction in vertigo frequency, achieving a 73% reduction compared to placebo after 3 months, indicating its potential efficacy in managing symptoms of Ménière's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, double-blind, placebo-controlled clinical study to assess safety and clinical activity of OTO-104 given as a single intratympanic injection in patients with unilateral Ménière's disease. Lambert, PR., Nguyen, S., Maxwell, KS., et al.[2022]

Intratympanic steroid treatment may slightly reduce the frequency of vertiginous attacks in patients with Menière's disease, but the evidence is weak and based on very low-quality studies.

No serious adverse events were reported, indicating that the treatment is likely safe; however, further research is necessary to determine its overall efficacy and safety in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intratympanic Steroid for Menière's Disease: A Systematic Review. Devantier, L., Djurhuus, BD., Hougaard, DD., et al.[2020]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10620247/

A randomized, double-blind, placebo-controlled phase 2 study ...

Intratympanic administration of OTO-313 and placebo produced reductions in tinnitus with a similar percentage of TFI responders at Weeks 4, 8, 12, and 16.

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04829214

Study Details | NCT04829214 | OTO-313 in Subjects With ...

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 ...

3.

journals.lww.com

journals.lww.com/otology-neurotology/fulltext/2021/12000/intratympanic_administration_of_oto_313_reduces.51.aspx

Intratympanic Administration of OTO-313 Reduces Tinnitus ...

OTO-313 was well-tolerated and demonstrated a higher proportion of responders than placebo across consecutive visits (Weeks 4 and 8) supporting further clinical ...

4.

hra.nhs.uk

hra.nhs.uk/planning-and-improving-research/application-summaries/research-summaries/a-study-of-oto-313-given-as-an-injection-in-patients-with-tinnitus/

A study of OTO-313 given as an injection in patients with ...

Overall, OTO-313 was safe in this trial. Efficacy Results: The main reason for this study was to see if OTO-313 reduced tinnitus symptoms by seeing the ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03918109?term=AREA%5BLeadSponsorName%5D(Otonomy)&rank=3

OTO-313 in Subjects With Subjective Tinnitus

The purpose of this study is to evaluate the safety, tolerability, plasma pharmacokinetics (PK), and exploratory efficacy of OTO-313 administered as an ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8584222/

Intratympanic Administration of OTO-313 Reduces Tinnitus in ...

The drug was generally safe and well-tolerated and reduced subjective ratings of tinnitus in four of six patients evaluated. OTO-313 is a lipid-based ...

7.

link.springer.com

link.springer.com/article/10.1007/s00405-023-08047-0

A randomized, double-blind, placebo-controlled phase 2 ...

This was a randomized, double-blind, placebo-controlled Phase 2 study to evaluate the efficacy and safety of intratympanic OTO-313 in patients

8.

withpower.com

withpower.com/trial/phase-3-tinnitus-2-2021-eed2a

OTO-313 in Subjects With Unilateral Subjective Tinnitus

Studies on OTO-313, used for tinnitus, have looked at its safety and found it generally safe when given as an ear injection. No major safety concerns were ...