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COMPLETEDPHASE2

OTO-104 for the Treatment of Meniere's Disease

A Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 2b Study of OTO-104 Given as a Single Intratympanic Injection in Subjects With Unilateral Meniere's Disease

NCT01412177•Otonomy, Inc.

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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.
•Subjects currently on a low-salt diet and/or diuretic at the time of screening agree to continue this treatment throughout the study.

Exclusion Criteria

•Subject is pregnant or lactating.
•Subject has a history of immunodeficiency disease.
•Subject has a history of previous endolymphatic sac surgery.
•Subject has a history of previous use of intratympanic (IT) gentamicin in the affected ear.
•Subject has a history of tympanostomy tubes with evidence of perforation or lack of closure.
•Subject has experienced an adverse reaction to IT injection of steroids.
•Subject has used an investigational drug or device in the 3 months prior to screening.
•Subject has previously been randomized to a trial of OTO-104.

Locations (2)

Many sites in US and Canada. Refer to the contact info listed below.

San Diego, California, United States

UC Health Otolaryngology - Head and Neck Surgery

Cincinnati, Ohio, United States

Key Dates

Start Date

November 1, 2013

Primary Completion Date

March 1, 2015

Completion Date

April 1, 2015

Last Updated

September 3, 2015

Enrollment

154

ACTUAL participants

Conditions

Meniere's Disease

Interventions

OTO-104

DRUG

Placebo

DRUG

SPI-1005 for the Treatment of Meniere's Disease (Open Label)

NCT06859788

Meniere's DiseaseMénière's Disease

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TERMINATEDPHASE3

A 6-Month Extension Study of OTO-104 in Meniere's Disease

NCT02768662

Meniere's Disease

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TERMINATEDPHASE4

Evaluation of Inner Ear and Brain Structures With Contrast-enhanced MRI in Patients With Meniere's Disease

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 3, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

OTO-104 for the Treatment of Meniere's Disease

Inclusion Criteria

Exclusion Criteria

SPI-1005 for the Treatment of Meniere's Disease (Open Label)

A 6-Month Extension Study of OTO-104 in Meniere's Disease

Evaluation of Inner Ear and Brain Structures With Contrast-enhanced MRI in Patients With Meniere's Disease

Open Label Study of OTO-104 in Subjects With Meniere's Disease

Isobide Solution and Meniace Tablets Compared to Monotherapy With Meniace Tablets

Clinical Trial of Traditional Chinese Diaoshi Jifa Therapy of Meniere's Disease