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Open Label Study of OTO-104 in Subjects With Meniere's Disease | Clinical Trials | Clareo Health

TERMINATEDPHASE2

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

A 1-Year, Phase 2, Open-Label Safety Study of OTO-104 Given at 3-Month Intervals by Intratympanic Injection in Subjects With Unilateral Meniere's Disease

NCT02740387•Otonomy, Inc.

View on ClinicalTrials.gov

Summary

This is a 1-year, multicenter, Phase 2, open-label safety study in subjects with unilateral Meniere's disease. Subjects will receive 1 intratympanic (IT) injection of 12 mg OTO-104 at 3-month intervals for a total of 4 injections total.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subject has a diagnosis of definite unilateral Meniere's disease.
•Subject agrees to maintain their current standard of care treatments for Meniere's disease while on-study.

Exclusion Criteria

•Subject has an infection in the ear, sinuses, or upper respiratory system.
•Subject is pregnant or lactating.
•Subject has a history of immunodeficiency disease.
•Subject has active or recent (\<1 month prior to screening) middle ear disease, including but not limited to: chronic otitis media, acute otitis media, middle ear effusions, middle ear atelectasis, or cholesteatoma.
•Subject has experienced an adverse reaction to intratympanic injection of steroids.

Locations (1)

Call Otonomy call center for trial locations

London, Ontario, Canada

Key Dates

Start Date

June 1, 2016

Primary Completion Date

September 1, 2017

Completion Date

September 1, 2017

Last Updated

September 15, 2017

Enrollment

ACTUAL participants

Conditions

Meniere's Disease

Interventions

OTO-104

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 15, 2017Data 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

Open Label Study of OTO-104 in Subjects With 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

Isobide Solution and Meniace Tablets Compared to Monotherapy With Meniace Tablets

OTO-104 for the Treatment of Meniere's Disease

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