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Study of OTO-104 in Subjects With Unilateral Meniere's Disease (AVERTS-1)

Primary Purpose

Meniere's Disease

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
OTO-104
Placebo
Sponsored by
Otonomy, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Meniere's Disease focused on measuring Meniere's Disease, Vertigo

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Many sites in US. Refer to the contact info listed below.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

OTO-104

Placebo

Arm Description

12 mg dexamethasone

Outcomes

Primary Outcome Measures

The Number of DVD at Week 12 (Defined as the 4-week [28 Days] Interval From Week 9 Through Week 12).
The number of DVDs at Week 12 (defined as the 4-week [28 days] interval from Week 9 through Week 12) was compared between OTO-104 and placebo. Week 12 = 12 weeks after dosing at the Baseline visit. Baseline occurred at the end of lead-in and no intervention was administered during lead-in.

Secondary Outcome Measures

Effect of Vertigo on Daily Activities - Number of Days Sick at Home or Bedridden at Week 12 (Month 3)
Questionnaire - subjects were instructed to record the effect on their daily activities of their total vertigo experienced that day using a 5-point scoring system: 0 = normal activity = slight limitation = moderate limitation = sick at home = bed ridden
Otoscopic Examination - Tympanic Membrane Perforation at Week 12 (Month 3)
Otoscopic examinations were conducted at each visit. It was considered important to understand if the tympanic perforation that resulted from the IT injection at the Baseline visit persisted at the end of study visit (Week 12 [Month 3]).
Audiometry - Shift in Air-Bone Gap at 500 Hz From Baseline to Week 12 (Month 3)
The number of subjects with a change in air-bone gap from Baseline to Week 12 (Month 3) from no impairment at baseline (<= 10 dB) to impairment at Month 3 (>10 dB) when measured at 500 Hz.
Audiometry - Shift in Air-Bone Gap at 1000 Hz From Baseline to Week 12 (Month 3)
The number of subjects with a change in air-bone gap from Baseline to Week 12 (Month 3) from no impairment at baseline (<= 10 dB) to impairment at Month 3 (>10 dB) when measured at 1000 Hz.
Audiometry - Shift in Air-Bone Gap at 2000 Hz From Baseline to Week 12 (Month 3)
The number of subjects with a change in air-bone gap from Baseline to Week 12 (Month 3) from no impairment at baseline (<= 10 dB) to impairment at Month 3 (>10 dB) when measured at 2000 Hz.

Full Information

First Posted
November 18, 2015
Last Updated
December 19, 2022
Sponsor
Otonomy, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02612337
Brief Title
Study of OTO-104 in Subjects With Unilateral Meniere's Disease
Acronym
AVERTS-1
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
October 27, 2015 (Actual)
Primary Completion Date
July 18, 2017 (Actual)
Study Completion Date
July 18, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otonomy, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meniere's Disease
Keywords
Meniere's Disease, Vertigo

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
166 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OTO-104
Arm Type
Experimental
Arm Description
12 mg dexamethasone
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
OTO-104
Intervention Description
Single intratympanic injection of 12 mg OTO-104
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Single intratympanic injection of placebo
Primary Outcome Measure Information:
Title
The Number of DVD at Week 12 (Defined as the 4-week [28 Days] Interval From Week 9 Through Week 12).
Description
The number of DVDs at Week 12 (defined as the 4-week [28 days] interval from Week 9 through Week 12) was compared between OTO-104 and placebo. Week 12 = 12 weeks after dosing at the Baseline visit. Baseline occurred at the end of lead-in and no intervention was administered during lead-in.
Time Frame
Week 12 (3 months)
Secondary Outcome Measure Information:
Title
Effect of Vertigo on Daily Activities - Number of Days Sick at Home or Bedridden at Week 12 (Month 3)
Description
Questionnaire - subjects were instructed to record the effect on their daily activities of their total vertigo experienced that day using a 5-point scoring system: 0 = normal activity = slight limitation = moderate limitation = sick at home = bed ridden
Time Frame
3 months
Title
Otoscopic Examination - Tympanic Membrane Perforation at Week 12 (Month 3)
Description
Otoscopic examinations were conducted at each visit. It was considered important to understand if the tympanic perforation that resulted from the IT injection at the Baseline visit persisted at the end of study visit (Week 12 [Month 3]).
Time Frame
3 months
Title
Audiometry - Shift in Air-Bone Gap at 500 Hz From Baseline to Week 12 (Month 3)
Description
The number of subjects with a change in air-bone gap from Baseline to Week 12 (Month 3) from no impairment at baseline (<= 10 dB) to impairment at Month 3 (>10 dB) when measured at 500 Hz.
Time Frame
3 months
Title
Audiometry - Shift in Air-Bone Gap at 1000 Hz From Baseline to Week 12 (Month 3)
Description
The number of subjects with a change in air-bone gap from Baseline to Week 12 (Month 3) from no impairment at baseline (<= 10 dB) to impairment at Month 3 (>10 dB) when measured at 1000 Hz.
Time Frame
Week 12 (Month 3)
Title
Audiometry - Shift in Air-Bone Gap at 2000 Hz From Baseline to Week 12 (Month 3)
Description
The number of subjects with a change in air-bone gap from Baseline to Week 12 (Month 3) from no impairment at baseline (<= 10 dB) to impairment at Month 3 (>10 dB) when measured at 2000 Hz.
Time Frame
Week 12 (Month 3)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathie Bishop, PhD
Organizational Affiliation
Otonomy, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Many sites in US. Refer to the contact info listed below.
City
San Diego
State/Province
California
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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