OTO-104 for the Treatment of Meniere's Disease

Phase 2

Completed

• Conditions: Meniere's Disease
• Interventions: Drug: OTO-104; Drug: Placebo

• Registration Number: NCT01412177
• Lead Sponsor: Otonomy, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-07-31
• Study First Submitted QC: 2011-08-08
• Study First Posted: 2011-08-09
• Study Start: 2013-11
• Primary Completion: 2015-03
• Study Completion: 2015-04
• Status Verified: 2015-08
• Disposition First Submitted: 2015-08-18
• Disposition First Submitted QC: 2015-08-18
• Last Update Submitted: 2015-08-18
• Disposition First Posted: 2015-09-03
• Last Update Posted: 2015-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OTO-104	OTO-104	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Reduction in vertigo frequency as measure of efficacy of OTO-104 in subjects with Meniere's disease	4 months

Secondary Outcome Measures

Name	Time	Method
Evaluation of adverse events, otoscopic exams, audiometry, Word Recognition Score and tympanometry as a measure of safety and tolerability	4 months
Evaluation of tinnitus patient reported questionnaire and daily diary as a measure of impact of tinnitus on activities of daily living	4 months
Evaluation of patient reported questionnaires as a measure of impact on patient daily activities	4 months

Trial Locations

Locations (2)

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, United States