Meniere DiseasePhase 3NCT03664674
Phase 3 Study of OTO-104 in Subjects With Unilateral Meniere's Disease
A Phase 3 study testing OTO-104 in people with Meniere Disease, run by Otonomy, Inc. at 65 sites in 8 countries.
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 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
- 148 participants
- Where
- 65 sitesin 8 countries
- Study dates
- 27 Aug 2018to 22 Dec 2020
- 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 significant middle ear or inner ear surgery, or endolymphatic sac surgery in the affected ear.
- Subject has a history of tympanostomy tubes with evidence of perforation or lack of closure.
- Subject has a history of vestibular migraine.
- Subject has used an investigational drug or device in the 3 months prior to screening.
- Subject has previously been randomized to a clinical study of OTO-104.
Trial locations and contacts
65 sites in 8 countries.
65 sites in 8 countries
United States17 sites
Dent Neurologic Institute
Amherst, New York, 14226
University of Colorado School of Medicine
Aurora, Colorado, 80045
Ear, Nose and Throat Associates of South Florida
Boynton Beach, Florida, 33426
Medical University of South Carolina, Department of Otolaryngology
Charleston, South Carolina, 29425
Colorado ENT & Allergy
Colorado Springs, Colorado, 80909
Intermountain Ear, Nose & Throat Specialists
Draper, Utah, 84020
Michigan Ear Institute
Farmington Hills, Michigan, 48334
Central California Clinical Research
Fresno, California, 93720
Tandem Clinical Research
Marrero, Louisiana, 70072
Charlotte Eye Ear Nose & Throat Associates, P.A.
Matthews, North Carolina, 28105
West Virginia University School of Medicine
Morgantown, West Virginia, 26506
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Yale University School of Medicine
New Haven, Connecticut, 06510
New York Eye and Ear Infirmary of Mount Sinai
New York, New York, 10003
Ear Research Foundation
Sarasota, Florida, 34239
Saint Louis University
St Louis, Missouri, 63110
Piedmont Ear, Nose, and Throat Associates, PA
Winston-Salem, North Carolina, 27103
Germany11 sites
Uniklinik RWTH Aachen, Klinik für Hals-, Nasen-, Ohrenheilkunde und Plastische Kopf- und Halschirurgie
Aachen, 52074
Praxis Bad Essen
Bad Essen, 49152
Charité Universitätsmedizin Berlin
Berlin, 10117
HNO Zentrum am Kudamm
Berlin, 10629
HNO-Praxis Göttingen
Göttingen, 37073
HNO Praxis am Neckar
Heidelberg, 69120
HNO Praxis Dres. med. Florian Heimlich und Angelika Witzel-Heimlich
Heidelberg, 69126
Universitätsklinikum Mannheim
Mannheim, 68167
HNO Praxis Dr. med. Roger Fisher
Markkleeberg, 04416
Klinikum der Universität München
München, 81377
Universitätsklinikum Ulm, HNO-Klinik. Kopf-Hals-Chirurgie
Ulm, 89075
United Kingdom10 sites
Royal Victoria Hospital
Belfast, BT126BA
Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB20QQ
University Hospital of Wales
Cardiff, CF144XW
Ninewells Hospital and Medical School
Dundee, Angus, DD19SY
Gloucestershire Royal Hospital
Gloucester, GL13NN
University Hospitals of Leicester NHS Trust, Leicester Royal Infirmary
Leicester, LE15WW
Guy's and St Thomas' NHS Foundation Trust
London, SE19RT
Manchester Head and Neck Centre, Peter Mount Building
Manchester, M139WL
Norfolk & Norwich University Hospital
Norwich, NR47UY
The Royal Hallamshire Hospital
Sheffield, S102JF
Turkey (Türkiye)8 sites
Hacettepe Universitesi Tip Fakultesi Kulak Burun Bogaz Hastaliklari Anabilim Dali
Ankara, 06100
Baskent Universitesi Ankara Hastanesi, Kulak Burun Bogaz Hastaliklari Ana Bilim Dali
Ankara, 06490
Bayindir Hastanesi Sogutozu, Kulak Burun Bogaz Bas ve Boyun Cerrahisi Bolumu
Ankara, 06530
Uludag Universitesi Saglik Uygulama ve Arastirma Merkezi, Kulak Burum Bogaz Hastaliklari Ana Bilim Dali
Bursa, 16059
Istanbul Universitesi Istanbul Tip Fakultesi Kulak Burun Bogaz Hastaliklari Anabilim Dali
Istanbul, 34093
Acibadem Maslak Hastanesi Kulak Burun Bogaz Bolumu
Istanbul, 34457
Ege Universitesi Tip Fakultesi Kulak Burun Bogaz Hastaliklari Anabilim Dali
Izmir, 35100
Dokuz Eylul Universitesi Tip Fakultesi Tip Bilimleri Bolumu Kulak Burun Bogaz Anabilim Dali
Izmir, 35340
Poland7 sites
10 Wojskowy Szpital Kliniczny z Polikliniką SP ZOZ Oddział
Bydgoszcz, 85-681
Centrum Medyczne ZDROWA
Krakow, 31-216
Centrum Medyczne PROMED
Krakow, 31-411
MT Medic Specjalistyczna Praktyka Lekarska Tomasz Stapiński
Krosno, 38-400
ETG Łódź
Lodz, 90-302
Centrum Słuchu i Mowy Sp. z o.o.
Nadarzyn, 05-830
Kliniczny Szpital Wojewódzki Nr 1 im. Fryderyka Chopina
Rzeszów, 35-055
Belgium4 sites
Universitair Ziekenhuis Antwerpen - Ear-Nose-Throat Department
Edegem, 2650
UZ Gent - Ear-Nose-Throat Department
Ghent, 9000
UZ Leuven - Ear-Nose-Throat Department
Leuven, 3000
CHU de Liège - Ear-Nose-Throat Department
Liège, 4000
Italy4 sites
U.O. di Otorinolaringoiatria Universitaria
Bari, NAP, 70124
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico - U.O.S.D. Audiologia
Milan, 20122
Unità Operativa di Otorinolaringoiatria
Piacenza, 29121
Azienda Ospedaliera-Universitaria Sant' Andrea; Dipartimento Organi di Senso-U.O.C. Otorinolaringoiatria
Roma, 00189
Spain4 sites
Agencia Pública Empresarial Sanitaria Hospital de Poniente
El Ejido, Almería, 04700
Hospital Universitario de Getafe
Getafe, Madrid, 28905
Hospital Universitario Virgen de las Nieves
Granada, 18014
Hospital Universitario Virgen Macarena
Seville, 41009
About this study
Official title: A Prospective, Randomized, Double Blind, Placebo-controlled, Multicenter, Phase 3 Efficacy and Safety 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 Disease
- Being tested
- OTO-104, Placebo
- Keywords
- Meniere's Disease, Vertigo, Endolymphatic Hydrops, Labyrinth Diseases, Ear Diseases, Otorhinolaryngologic Diseases
- Medical subject headings
- Meniere Disease, Vertigo, Endolymphatic Hydrops, Labyrinth Diseases, Ear Diseases, Otorhinolaryngologic Diseases
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 dexamethasone
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.
28-Day Average DVD at Week 12 (Month 3)
The count of definitive vertigo days for Week 12 was determined during the 4-week period between Weeks 9 and 12. The 28-day average DVD was derived for each subject and visit by summing each subject's number of DVD counts within the 4-week interval, dividing by the number of completed diary days, and multiplying by 28.
Measured: 3 months
Secondary outcomes (5)
Impact of Vertigo Experience on Daily Activities at Week 12 (Month 3) - The Number of Days Sick at Home or Bedridden
The count of days sick at home or bedridden for subsequent intervals was determined during the 4-week period between each visit. The count of days sick at home or bedridden was computed as the sum of the days in the Sick at home and Bedridden categories for each 4-week interval and was standardized to 28 days by multiplying by 28 days and dividing by the number of non-missing diary entries.
Measured: 3 Months
Otoscopic Examination - Presence of Perforation in the Treated Ear at Week 12 (Month 3) Final Visit
Ear examinations were done at every visit. One of the important safety endpoints was an observation of a perforation in the ear drum did not heal properly after the injection. Reported here are the Week 12 (Month 3) final visit.
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)
Audiometry - Shift in Air-Bone Gap at 4000 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 4000 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.
- First posted10 Sep 2018
- Study start27 Aug 2018
- Primary completion22 Dec 2020
- Study completion22 Dec 2020
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 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
- Model description
- Randomized, Double-blind, Placebo-controlled, Multicenter
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otonomy, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03664674
- Sponsor's protocol ID
- 104-201811
- Status last verified
- Nov 2022
- First submitted
- 31 Aug 2018
- Last updated
- 7 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. 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 Efficacy and Safety Study of OTO-104 Given as a Single Intratympanic Injection in Subjects With Unilateral Meniere's Disease
- ClinicalTrials.gov ID
- NCT03664674
- Acronym / sponsor ID
- 104-201811
- Conditions
- Meniere Disease
- Keywords
- Meniere's Disease, Vertigo, Endolymphatic Hydrops, Labyrinth Diseases, Ear Diseases, Otorhinolaryngologic Diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Otonomy, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Aug 2018 (actual)
- Primary completion
- 22 Dec 2020 (actual)
- Study completion
- 22 Dec 2020 (actual)
- First posted
- 10 Sep 2018 (actual)
- Results
- Posted 7 Dec 2022
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
- Model description
- Randomized, Double-blind, Placebo-controlled, Multicenter
| Arm | Type | Receives |
|---|---|---|
| OTO-104 | Experimental | Drug: OTO-104 |
| 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 (7 listed)
- Subject is pregnant or lactating.
- Subject has a history of immunodeficiency disease.
- Subject has a history of significant middle ear or inner ear surgery, or endolymphatic sac surgery in the affected ear.
- Subject has a history of tympanostomy tubes with evidence of perforation or lack of closure.
- Subject has a history of vestibular migraine.
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 dexamethasone | Drug | OTO-104 |
| PlaceboSingle intratympanic injection of placebo | Drug | placebo |
Primary outcome
28-Day Average DVD at Week 12 (Month 3)
Time frame: 3 months
The count of definitive vertigo days for Week 12 was determined during the 4-week period between Weeks 9 and 12. The 28-day average DVD was derived for each subject and visit by summing each subject's number of DVD counts within the 4-week interval, dividing by the number of completed diary days, and multiplying by 28.
5 secondary outcomes
Impact of Vertigo Experience on Daily Activities at Week 12 (Month 3) - The Number of Days Sick at Home or Bedridden
Time frame: 3 Months
Otoscopic Examination - Presence of Perforation in the Treated Ear at Week 12 (Month 3) Final Visit
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)
Audiometry - Shift in Air-Bone Gap at 4000 Hz From Baseline to Week 12 (Month 3)
Time frame: Week 12 (Month 3)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2022.
- 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.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
65 sites in 8 countries: 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 Disease, run by Otonomy, Inc. at 65 sites in 8 countries.
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 7 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 7 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 65 sites in United States, Germany, United Kingdom, Turkey (Türkiye), Poland and 3 more countries. 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 7 Dec 2022). 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?
28-Day Average DVD at Week 12 (Month 3) (time frame: 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 NCT03664674, 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 7 Dec 2022.