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

Meniere's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02740387
• Other study ID #: 104-201505
• Status: Terminated
• Phase: Phase 2
• First received: March 25, 2016
• Last updated: September 14, 2017
• Start date: June 2016
• Est. completion date: September 2017

Study information

• Verified date: September 2017
• Source: Otonomy, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 34
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria includes, but is not limited to:

• 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 includes, but is not limited to:

• 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.

Related Conditions & MeSH terms

• Meniere Disease
• Meniere's Disease

Intervention

Drug:
• OTO-104

Locations

Country	Name	City	State
Canada	Call Otonomy call center for trial locations	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Otonomy, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of adverse events as a measure of safety and tolerability		Up to 1 Year
Secondary	Change in hearing from baseline as assessed by audiometry		Up to 1 Year
Secondary	Changes in patient condition assessed by otoscopy		Up to 1 Year
Secondary	Changes in patient condition assessed by tympanometry		Up to 1 Year