Purpose

The purpose of this study is to evaluate the effectiveness of OTO-104 for the treatment of Meniere's disease.

Condition

Eligibility

Eligible Ages
Between 18 Years and 85 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Subject has a diagnosis of unilateral Meniere's disease by 1995 American Academy of Otolaryngology - Head and Neck Surgery (AAOHNS) criteria and reports active vertigo for the 2 months prior to the study lead-in period.
  • Subject has experienced active vertigo during the lead-in period.
  • Subject has documented asymmetric sensorineural hearing loss.
  • Subject agrees to maintain their current treatments for Meniere's disease while on-study.

Exclusion Criteria

  • Subject is pregnant or lactating.
  • Subject has a history of immunodeficiency disease.
  • Subject has a history of significant middle ear or inner ear surgery, or endolymphatic sac surgery in the affected ear.
  • Subject has a history of tympanostomy tubes with evidence of perforation or lack of closure.
  • Subject has a history of vestibular migraine.
  • Subject has used an investigational drug or device in the 3 months prior to screening.
  • Subject has previously been randomized to a clinical study of OTO-104.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Randomized, Double-blind, Placebo-controlled, Multicenter
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
OTO-104
  • Drug: OTO-104
    Single intratympanic injection of 12 mg dexamethasone
Placebo Comparator
placebo
  • Drug: Placebo
    Single intratympanic injection of placebo

Recruiting Locations

Vanderbilt University Medical Center
Nashville, Tennessee 37232
Contact:
Ashudee Kirk, MS
615-936-2491
vbwcresearch@vumc.org

More Details

Status
Recruiting
Sponsor
Otonomy, Inc.

Study Contact

Clinical Study Manager
otonomyclinicaltrials@otonomy.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.