Meniere's DiseasePhase 3AVERTS-1NCT02612337

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

A Phase 3 study testing OTO-104 in people with Meniere's Disease, run by Otonomy, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Meniere's Disease
What is being tested?: OTO-104
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 166 participants
Where: 1 siteUnited States
Study dates: 27 Oct 2015to 18 Jul 2017
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Many sites in US. Refer to the contact info listed below.
San Diego, California

Other trials in United States

About this study

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

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

Conditions: Meniere's Disease
Being tested: OTO-104, Placebo
Keywords: Meniere's Disease, Vertigo
Medical subject headings: Meniere Disease, Vertigo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OTO-104Drug
Single intratympanic injection of 12 mg OTO-104
PlaceboDrug
Single intratympanic injection of placebo

Study groups in NCT02612337
Study group	Role	What they receive
OTO-104	Experimental	12 mg dexamethasone Receives: Drug: OTO-104
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Week 12 (3 months)

Secondary outcomes (5)

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
1. = slight limitation
2. = moderate limitation
3. = sick at home
4. = bed ridden
Measured: 3 months
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]).
Measured: 3 months
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.
Measured: 3 months
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.
Measured: Week 12 (Month 3)
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.
Measured: Week 12 (Month 3)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Oct 201518 Jul 2017

First posted23 Nov 2015 (estimated)
Study start27 Oct 2015
Primary completion18 Jul 2017
Study completion18 Jul 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Meniere's DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 166 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02612337
Sponsor's protocol ID: 104-201506
Acronym: AVERTS-1
Status last verified: Dec 2022
First submitted: 18 Nov 2015
Last updated: 12 Jan 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Phillips J, Mikulec AA, Robinson JM, Skarinsky D, Anderson JJ. Efficacy of Intratympanic OTO-104 for the Treatment of Meniere's Disease: The Outcome of Three Randomized, Double-Blind, Placebo-Controlled Studies. Otol Neurotol. 2023 Jul 1;44(6):584-592. doi: 10.1097/MAO.0000000000003886. Epub 2023 Apr 22.
PubMed 37185596

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Treatment of Meniere's Disease With Migraine Medications
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Effects of Anakinra in Subjects With Corticosteroid-resistant/Intolerant Meniere's Disease and Autoimmune Inner Ear Disease
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All Meniere's Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02612337
Acronym / sponsor ID: AVERTS-1 / 104-201506
Conditions: Meniere's Disease
Keywords: Meniere's Disease, Vertigo
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 166 participants (actual)
Lead sponsor: Otonomy, Inc.Industry (pharma, biotech, devices)
Study start: 27 Oct 2015 (actual)
Primary completion: 18 Jul 2017 (actual)
Study completion: 18 Jul 2017 (actual)
First posted: 23 Nov 2015 (estimated)
Results: Posted 12 Jan 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
OTO-104	Experimental	Drug: OTO-10412 mg dexamethasone
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (8 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OTO-104Single intratympanic injection of 12 mg OTO-104	Drug	OTO-104
PlaceboSingle intratympanic injection of placebo	Drug	Placebo

Primary outcome

The Number of DVD at Week 12 (Defined as the 4-week [28 Days] Interval From Week 9 Through Week 12).
Time frame: Week 12 (3 months)
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.

5 secondary outcomes

Effect of Vertigo on Daily Activities - Number of Days Sick at Home or Bedridden at Week 12 (Month 3)
Time frame: 3 months
Otoscopic Examination - Tympanic Membrane Perforation at Week 12 (Month 3)
Time frame: 3 months
Audiometry - Shift in Air-Bone Gap at 500 Hz From Baseline to Week 12 (Month 3)
Time frame: 3 months
Audiometry - Shift in Air-Bone Gap at 1000 Hz From Baseline to Week 12 (Month 3)
Time frame: Week 12 (Month 3)
Audiometry - Shift in Air-Bone Gap at 2000 Hz From Baseline to Week 12 (Month 3)
Time frame: Week 12 (Month 3)

Results and safety

Results posted to the registry on 12 Jan 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
OTO-104	83	80
Placebo	83	80

Primary outcome: The Number of DVD at Week 12 (Defined as the 4-week [28 Days] Interval From Week 9 Through Week 12).

Time frame: Week 12 (3 months). Least squares mean (95% Confidence Interval). Unit: Definitive Vertigo Day

Measure	OTO-104 (Full Analysis Set) n = 83	Placebo (Full Analysis Set) n = 82
Value	2.191 (1.644 to 2.919)	2.415 (1.823 to 3.198)

OTO-104 (Full Analysis Set) vs Placebo (Full Analysis Set): Risk Ratio (RR): 0.907 (95% CI 0.615 to 1.339), p = 0.623, Regression, Linear

Population analysed: The full analysis set subjects who were randomized, received study drug, had a baseline definitive vertigo measurement for the 4-week lead-in period and at least one 4-week definitive vertigo measurement post-baseline, i.e., at least 1 post-baseline daily diary entry.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Reported or observed during or after dosing with the study drug at the Baseline visit up to the Week 12 (Month 3) end of study visit. The Baseline visit occurred after the Lead-in period when no intervention was administered. Therefore, collection of adverse events started during dosing at the Baseline visit and lasted to the end of the study (Week 12 (Month 3).. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
OTO-104 (Safety Analysis Set)	2 of 82 (2.4%)	34 of 82 (41.5%)	0 of 82
Placebo (Safety Analysis Set)	2 of 83 (2.4%)	30 of 83 (36.1%)	0 of 83

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37185596Phillips J, Mikulec AA, Robinson JM, Skarinsky D, Anderson JJ. Efficacy of Intratympanic OTO-104 for the Treatment of Meniere's Disease: The Outcome of Three Randomized, Double-Blind, Placebo-Controlled Studies. Otol Neurotol. 2023 Jul 1;44(6):584-592. doi: 10.1097/MAO.0000000000003886. Epub 2023 Apr 22.
Please click on this link for more information regarding this study and referral to the closest study site if you qualify (http://otonomyresearch.com).Link provided by the sponsor.

Related trials for Meniere's Disease

Active, not recruiting
CI Following VS Removal or Labyrinthectomy
Vestibular Schwannoma, Meniere Disease
Active, not recruitingPhase 3
SPI-1005 for the Treatment of Meniere's Disease (Open Label)
Meniere's Disease, Ménière's Disease
RecruitingObservational study
Deep Phenotyping of Hearing Instability Disorders: Cohort Establishment, Biomarker Identification, Development of Novel Phenotyping Measures, and Discovery of Therapeutic Targets
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RecruitingPhase 4
Treatment of Meniere's Disease With Migraine Medications
Ménière
RecruitingPhase 2
Effects of Anakinra in Subjects With Corticosteroid-resistant/Intolerant Meniere's Disease and Autoimmune Inner Ear Disease
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kathie Bishop, PhD study chair

Otonomy, Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing OTO-104 in people with Meniere's Disease, run by Otonomy, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Number of DVD at Week 12 (Defined as the 4-week [28 Days] Interval From Week 9 Through Week 12). (time frame: Week 12 (3 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02612337, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2023.