OTO-104 for the Treatment of Meniere's Disease

Meniere's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01412177
• Other study ID #: 104-201102
• Status: Completed
• Phase: Phase 2
• First received: July 31, 2011
• Last updated: August 18, 2015
• Start date: November 2013
• Est. completion date: April 2015

Study information

• Verified date: August 2015
• Source: Otonomy, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: April 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Meniere Disease
• Meniere's Disease

Intervention

Drug:
• OTO-104
Single intratympanic injection of 12 mg OTO-104
• Placebo
Single intratympanic injection of placebo

Locations

Country	Name	City	State
United States	UC Health Otolaryngology - Head and Neck Surgery	Cincinnati	Ohio
United States	Many sites in US and Canada. Refer to the contact info listed below.	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Otonomy, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in vertigo frequency as measure of efficacy of OTO-104 in subjects with Meniere's disease		4 months	No
Secondary	Evaluation of adverse events, otoscopic exams, audiometry, Word Recognition Score and tympanometry as a measure of safety and tolerability		4 months	Yes
Secondary	Evaluation of tinnitus patient reported questionnaire and daily diary as a measure of impact of tinnitus on activities of daily living		4 months	No
Secondary	Evaluation of patient reported questionnaires as a measure of impact on patient daily activities		4 months	No