AVERTS-2: Study of OTO-104 in Subjects With Unilateral Meniere's Disease

Sponsor

Otonomy, Inc. (Industry)

Overall Status

Terminated

CT.gov ID

NCT02717442

Collaborator

(none)

176

Enrollment

Location

Arms

17.8

Actual Duration (Months)

9.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Meniere's Disease	Drug: OTO-104 Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

176 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study of OTO-104 Given as a Single Intratympanic Injection in Subjects With Unilateral Meniere's Disease

Actual Study Start Date :

Mar 21, 2016

Actual Primary Completion Date :

Aug 31, 2017

Actual Study Completion Date :

Sep 15, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: OTO-104 12 mg dexamethasone	Drug: OTO-104 Single intratympanic injection of 12 mg OTO-104
Placebo Comparator: Placebo	Drug: Placebo Single intratympanic injection of placebo

Arm

Intervention/Treatment

Experimental: OTO-104

12 mg dexamethasone

Drug: OTO-104

Single intratympanic injection of 12 mg OTO-104

Placebo Comparator: Placebo

Drug: Placebo

Single intratympanic injection of placebo

Outcome Measures

Primary Outcome Measures

Reduction in number of definitive vertigo days compared to placebo as assessed by a daily diary [3 months]

Secondary Outcome Measures

Change in hearing from baseline as assessed by audiometry [3 months]
Change in the condition of the ear from baseline as assessed by otoscopic examinations [3 months]
Evaluation of adverse events as a measure of safety and tolerability [3 months]
Impact of vertigo experience on daily activities [3 months]
Questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria includes, but is not limited to:

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.

Exclusion Criteria includes, but is not limited to:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Many sites in Europe. Refer to the contact info listed below.	San Diego	California	United States	92121

Sponsors and Collaborators

Otonomy, Inc.

Investigators

Study Chair: Kathie Bishop, PhD, Otonomy, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Otonomy, Inc.

ClinicalTrials.gov Identifier:

NCT02717442

Other Study ID Numbers:

104-201508

First Posted:

Mar 23, 2016

Last Update Posted:

Feb 11, 2019

Last Verified:

Feb 1, 2019

Keywords provided by Otonomy, Inc.

Meniere's Disease

Vertigo

Additional relevant MeSH terms:

Meniere Disease

Study Results

No Results Posted as of Feb 11, 2019