Meniere's DiseasePhase 3NCT02768662

A 6-Month Extension Study of OTO-104 in 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.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

This is an open-label extension study of a single intratympanic injection of OTO-104 given every 3 months for a total of 2 injections. Subjects must have completed either Otonomy study 104-201403 (1-Year, Phase 2, Safety Study of OTO-104) or 104-201508 (Phase 3 Study of OTO-104) in order to be eligible for this… Read more about this study

Who is it for?: Ages 18 years and older
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?: No, everyone receives an active treatment
How many people: 142 participants
Where: 1 siteUnited States
Study dates: Aug 2016to Sep 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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject has completed the Phase 2 OTO-104 1-Year Safety Study (104-201403) or Phase 3 (104-201508) clinical study.
Subject has a diagnosis of definite unilateral Meniere's disease by 1995 AAO-HNS criteria

Who cannot join

Subject is pregnant or lactating.
Subject has a history of immunodeficiency disease.
Subject has experienced an adverse reaction to intratympanic injection of steroids.

Trial locations and contacts

1 site in 1 country.

United States1 site

Many sites in Europe. Refer to the contact info listed below.
San Diego, California, 92121

Other trials in United States

About this study

Official title: A 6-Month, Multicenter, Phase 3, Open-Label Extension Safety Study of OTO-104 Given At 3-Month Intervals by Intratympanic Injection in Subjects With Unilateral Meniere's Disease

Conditions: Meniere's Disease
Being tested: OTO-104
Medical subject headings: Meniere Disease

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

Study groups in NCT02768662
Study group	Role	What they receive
OTO-104	Experimental	12 mg dexamethasone Receives: Drug: OTO-104

What is being measured

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

Otoscopic Examination - Tympanic Membrane Perforation at Week 24 (Month 6)
Otoscopic exams were conducted at each visit. It was considered important to understand if the tympanic membrane perforation that resulted from the IT injection persisted at the end of study visit (24 Weeks [Month 6]).
Measured: 6 Months

Timeline

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

Aug 2016Sep 2017

First posted11 May 2016 (estimated)
Study startAug 2016
Primary completionSep 2017
Study completionSep 2017

Why it stopped: Negative Efficacy Results from the recently completed Phase 3 study 104-201506

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.
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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 142 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02768662
Sponsor's protocol ID: 104-201610
Status last verified: Dec 2022
First submitted: 9 May 2016
Last updated: 20 Jan 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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

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
Meniere's Disease, Enlarged Vestibular Aqueduct Syndrome
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
Autoimmune Inner Ear Disease, Meniere's Disease

All Meniere's Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 6-Month, Multicenter, Phase 3, Open-Label Extension Safety Study of OTO-104 Given At 3-Month Intervals by Intratympanic Injection in Subjects With Unilateral Meniere's Disease
ClinicalTrials.gov ID: NCT02768662
Acronym / sponsor ID: 104-201610
Conditions: Meniere's Disease
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Negative Efficacy Results from the recently completed Phase 3 study 104-201506
Enrolment: 142 participants (actual)
Lead sponsor: Otonomy, Inc.Industry (pharma, biotech, devices)
Study start: Aug 2016 (actual)
Primary completion: Sep 2017 (actual)
Study completion: Sep 2017 (actual)
First posted: 11 May 2016 (estimated)
Results: Posted 20 Jan 2023

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

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

Who may qualify

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

Key inclusion criteria (2 listed)

Subject has completed the Phase 2 OTO-104 1-Year Safety Study (104-201403) or Phase 3 (104-201508) clinical study.
Subject has a diagnosis of definite unilateral Meniere's disease by 1995 AAO-HNS criteria

Key exclusion criteria (3 listed)

Subject is pregnant or lactating.
Subject has a history of immunodeficiency disease.
Subject has experienced an adverse reaction to intratympanic injection of steroids.

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

Primary outcome

Otoscopic Examination - Tympanic Membrane Perforation at Week 24 (Month 6)
Time frame: 6 Months
Otoscopic exams were conducted at each visit. It was considered important to understand if the tympanic membrane perforation that resulted from the IT injection persisted at the end of study visit (24 Weeks [Month 6]).

Results and safety

Results posted to the registry on 20 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	142	56

Primary outcome: Otoscopic Examination - Tympanic Membrane Perforation at Week 24 (Month 6)

Time frame: 6 Months. Count of participants. Unit: Participants

Measure	OTO-104 n = 56
Perforation present: pinhole size	0
Perforation present: ≤25% tympanic membrane	0
Perforation present: >25% and ≤50% tympanic membrane	0
Perforation present: >50% tympanic membrane	0
Perforation not present	56
Perforation information missing	0

Population analysed: The 6-month Safety Analysis Set included all subjects who received at least 1 dose of study drug and completed the Month 6 visit

Adverse events

Time frame: Reported or observed during or after dosing with the study drug up until the end of the study (Month 6).. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
OTO-104	4 of 142 (2.8%)	37 of 142 (26.1%)	0 of 142

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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
Meniere's Disease, Enlarged Vestibular Aqueduct Syndrome
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
Autoimmune Inner Ear Disease, Meniere's Disease

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 2 inclusion and 3 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: stopped early, as of the sponsor's last update on 20 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. 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 20 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?

Otoscopic Examination - Tympanic Membrane Perforation at Week 24 (Month 6) (time frame: 6 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 NCT02768662.

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 20 Jan 2023.