OTO-313 in Subjects With Unilateral Subjective Tinnitus

Recruiting at 48 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

153 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing OTO-313, a medication, to see if it can help people who have ringing in one ear. The study aims to determine if the medication is safe and effective for reducing or eliminating the ringing sound.

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 OTO-313 safe for humans?

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 reported in these studies. ^{1 2 3 4 5}

How is the drug OTO-313 different from other treatments for tinnitus?

OTO-313 is unique because it is administered directly into the ear (intratympanic), targeting the inner ear specifically for treating tinnitus, which is a ringing or buzzing noise in one or both ears. This direct approach may offer more effective relief compared to other treatments that are taken orally or applied differently. ^{1 2 3 6 7}

Eligibility Criteria

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

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

Treatment Details

Interventions

• OTO-313
• Placebo

Participant Groups

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+

Findings from Research

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

A randomized, double-blind, placebo-controlled phase 2 study of intratympanic OTO-313 in patients with moderate to severe subjective tinnitus. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Intratympanic Administration of OTO-313 Reduces Tinnitus in Patients With Moderate to Severe, Persistent Tinnitus: A Phase 1/2 Study. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Ototoxicity of Long-Term α-Difluoromethylornithine for Skin Cancer Prevention. [2023]

4. United States 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. [2022]

5. Italy pubmed.ncbi.nlm.nih.gov

Pharmacological drugs inducing ototoxicity, vestibular symptoms and tinnitus: a reasoned and updated guide. [2014]

6. United States pubmed.ncbi.nlm.nih.gov

Intratympanic Steroid for Menière's Disease: A Systematic Review. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Efficacy of Intratympanic OTO-104 for the Treatment of Ménière's Disease: The Outcome of Three Randomized, Double-Blind, Placebo-Controlled Studies. [2023]