Meniere's DiseasePhase 2NCT02740387
Open Label Study of OTO-104 in Subjects With Meniere's Disease
A Phase 2 study testing OTO-104 in people with Meniere's Disease, run by Otonomy, Inc. at 1 site in Canada.
Trial summary
This is a 1-year, multicenter, Phase 2, open-label safety study in subjects with unilateral Meniere's disease. Subjects will receive 1 intratympanic (IT) injection of 12 mg OTO-104 at 3-month intervals for a total of 4 injections total. Read more about this study
- Who is it for?
- Ages 18 to 80 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?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2016to Sep 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has a diagnosis of definite unilateral Meniere's disease.
- Subject agrees to maintain their current standard of care treatments for Meniere's disease while on-study.
Who cannot join
- Subject has an infection in the ear, sinuses, or upper respiratory system.
- Subject is pregnant or lactating.
- Subject has a history of immunodeficiency disease.
- Subject has active or recent (<1 month prior to screening) middle ear disease, including but not limited to: chronic otitis media, acute otitis media, middle ear effusions, middle ear atelectasis, or cholesteatoma.
- Subject has experienced an adverse reaction to intratympanic injection of steroids.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 1-Year, Phase 2, Open-Label Safety Study of OTO-104 Given at 3-Month Intervals by Intratympanic Injection in Subjects With Unilateral Meniere's Disease
This is a 1-year, multicenter, Phase 2, open-label safety study in subjects with unilateral Meniere's disease. Subjects will receive 1 intratympanic (IT) injection of 12 mg OTO-104 at 3-month intervals for a total of 4 injections total.
- 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
Also called Single intratympanic injection 12 mg OTO-104
| 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.
Evaluation of adverse events as a measure of safety and tolerability
Measured: Up to 1 Year
Secondary outcomes (3)
Change in hearing from baseline as assessed by audiometry
Measured: Up to 1 Year
Changes in patient condition assessed by otoscopy
Measured: Up to 1 Year
Changes in patient condition assessed by tympanometry
Measured: Up to 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study startJun 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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otonomy, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kathie Bishop, PhD, Study chair, Otonomy, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02740387
- Sponsor's protocol ID
- 104-201505
- Status last verified
- Sep 2017
- First submitted
- 25 Mar 2016
- Last updated
- 15 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 1-Year, Phase 2, Open-Label Safety Study of OTO-104 Given at 3-Month Intervals by Intratympanic Injection in Subjects With Unilateral Meniere's Disease
- ClinicalTrials.gov ID
- NCT02740387
- Acronym / sponsor ID
- 104-201505
- Conditions
- Meniere's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Negative Efficacy Results from the recently completed Phase 3 study 104-201506
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Otonomy, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2016 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 15 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 1-year, multicenter, Phase 2, open-label safety study in subjects with unilateral Meniere's disease. Subjects will receive 1 intratympanic (IT) injection of 12 mg OTO-104 at 3-month intervals for a total of 4 injections total.
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 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject has a diagnosis of definite unilateral Meniere's disease.
- Subject agrees to maintain their current standard of care treatments for Meniere's disease while on-study.
Key exclusion criteria (5 listed)
- Subject has an infection in the ear, sinuses, or upper respiratory system.
- Subject is pregnant or lactating.
- Subject has a history of immunodeficiency disease.
- Subject has active or recent (<1 month prior to screening) middle ear disease, including but not limited to: chronic otitis media, acute otitis media, middle ear effusions, middle ear atelectasis, or cholesteatoma.
- 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-104Also: Single intratympanic injection 12 mg OTO-104 | Drug | OTO-104 |
Primary outcome
Evaluation of adverse events as a measure of safety and tolerability
Time frame: Up to 1 Year
3 secondary outcomes
Change in hearing from baseline as assessed by audiometry
Time frame: Up to 1 Year
Changes in patient condition assessed by otoscopy
Time frame: Up to 1 Year
Changes in patient condition assessed by tympanometry
Time frame: Up to 1 Year
Results and safety
The study was stopped early (reason given: Negative Efficacy Results from the recently completed Phase 3 study 104-201506). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2017.
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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 2 study testing OTO-104 in people with Meniere's Disease, run by Otonomy, Inc. at 1 site in Canada.
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 5 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 15 Sep 2017. 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 Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Negative Efficacy Results from the recently completed Phase 3 study 104-201506). Results are not available in the source record.
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?
Evaluation of adverse events as a measure of safety and tolerability (time frame: Up to 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Sep 2017.