Meniere's DiseasePhase 2NCT01412177
OTO-104 for the Treatment of Meniere's Disease
A Phase 2 study testing OTO-104 in people with Meniere's Disease, run by Otonomy, Inc. at 2 sites in United States.
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 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?
- Yes, some participants may receive a placebo
- How many people
- 154 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2013to Apr 2015
- 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 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.
- Subjects currently on a low-salt diet and/or diuretic at the time of screening agree to continue this treatment throughout the 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
2 sites in 1 country.
United States2 sites
UC Health Otolaryngology - Head and Neck Surgery
Cincinnati, Ohio, 45219
Many sites in US and Canada. Refer to the contact info listed below.
San Diego, California
About this study
Official title: A Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 2b 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, Definitive vertigo, Vertigo episodes, Vertigo frequency, Tinnitus, Hearing loss, Aural fullness
- Medical subject headings
- Meniere Disease, Vertigo, Tinnitus, Hearing Loss
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 group | Role | What they receive |
|---|---|---|
| OTO-104 | Experimental | Not described 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.
Reduction in vertigo frequency as measure of efficacy of OTO-104 in subjects with Meniere's disease
Measured: 4 months
Secondary outcomes (3)
Evaluation of adverse events, otoscopic exams, audiometry, Word Recognition Score and tympanometry as a measure of safety and tolerability
Measured: 4 months
Evaluation of tinnitus patient reported questionnaire and daily diary as a measure of impact of tinnitus on activities of daily living
Measured: 4 months
Evaluation of patient reported questionnaires as a measure of impact on patient daily activities
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2011 (estimated)
- Study startNov 2013
- Primary completionMar 2015
- Study completionApr 2015
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otonomy, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carl LeBel, PhD, Study chair, Otonomy, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01412177
- Sponsor's protocol ID
- 104-201102
- Status last verified
- Aug 2015
- First submitted
- 31 Jul 2011
- Last updated
- 3 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 2b Study of OTO-104 Given as a Single Intratympanic Injection in Subjects With Unilateral Meniere's Disease
- ClinicalTrials.gov ID
- NCT01412177
- Acronym / sponsor ID
- 104-201102
- Conditions
- Meniere's Disease
- Keywords
- Meniere's Disease, Vertigo, Definitive vertigo, Vertigo episodes, Vertigo frequency, Tinnitus, Hearing loss, Aural fullness
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Otonomy, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 9 Aug 2011 (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.
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-104 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 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.
- Subjects currently on a low-salt diet and/or diuretic at the time of screening agree to continue this treatment throughout the 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
Reduction in vertigo frequency as measure of efficacy of OTO-104 in subjects with Meniere's disease
Time frame: 4 months
3 secondary outcomes
Evaluation of adverse events, otoscopic exams, audiometry, Word Recognition Score and tympanometry as a measure of safety and tolerability
Time frame: 4 months
Evaluation of tinnitus patient reported questionnaire and daily diary as a measure of impact of tinnitus on activities of daily living
Time frame: 4 months
Evaluation of patient reported questionnaires as a measure of impact on patient daily activities
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2015.
- Please click on this link for more information regarding this study and referral to the closest study site if you qualify (http://menieresresearchstudy.com).Link provided by the sponsor.
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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.
Carl LeBel, PhD study chair
Otonomy, Inc.
2 sites 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 2 sites 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 5 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 3 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reduction in vertigo frequency as measure of efficacy of OTO-104 in subjects with Meniere's disease (time frame: 4 months). 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 3 Sep 2015.