Phase 3 Study of OTO-104 in Subjects With Unilateral Meniere's Disease

Recruitment Status
COMPLETED - HAS RESULTS
(See Contacts and Locations)Verified October 2022 by Otonomy, Inc.
Sponsor
Otonomy, Inc.
Information Provided by (Responsible Party)
Otonomy, Inc.
Clinicaltrials.gov Identifier
NCT03664674
Other Study ID Numbers:
104-201811
First Submitted
August 30, 2018
First Posted
September 9, 2018
Results First Posted
October 19, 2022
Last Update Posted
December 6, 2022
Last Verified
October 2022

ClinicalTrials.gov processed this data on November 2022. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Meniere Disease
Drug: OTO-104Drug: Placebo

Study Design

Study TypeInterventional
Actual Enrollment148 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingTriple
Primary PurposeTreatment
Official TitleA 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
Study Start DateAugust 26, 2018
Actual Primary Completion DateDecember 21, 2020
Actual Study Completion DateDecember 21, 2020

Groups and Cohorts

Group/CohortIntervention/Treatment
OTO-104
Drug: OTO-104
Single intratympanic injection of 12 mg dexamethasone
placebo
Drug: Placebo
Single intratympanic injection of placebo

Outcome Measures

Primary Outcome Measures
  1. 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.
Secondary Outcome Measures
  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
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.
Exclusion Criteria
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.

Contacts and Locations

Sponsors and CollaboratorsOtonomy, Inc.
Locations
Central California Clinical Research | Fresno California, United States, 93720University of Colorado School of Medicine | Aurora Colorado, United States, 80045Colorado ENT & Allergy | Colorado Springs Colorado, United States, 80909Yale University School of Medicine | New Haven Connecticut, United States, 06510Ear, Nose and Throat Associates of South Florida | Boynton Beach Florida, United States, 33426Ear Research Foundation | Sarasota Florida, United States, 34239Tandem Clinical Research | Marrero Louisiana, United States, 70072Michigan Ear Institute | Farmington Hills Michigan, United States, 48334Saint Louis University | St Louis Missouri, United States, 63110Dent Neurologic Institute | Amherst New York, United States, 14226New York Eye and Ear Infirmary of Mount Sinai | New York New York, United States, 10003Charlotte Eye Ear Nose & Throat Associates, P.A. | Matthews North Carolina, United States, 28105Piedmont Ear, Nose, and Throat Associates, PA | Winston-Salem North Carolina, United States, 27103Medical University of South Carolina, Department of Otolaryngology | Charleston South Carolina, United States, 29425Vanderbilt University Medical Center | Nashville Tennessee, United States, 37232Intermountain Ear, Nose & Throat Specialists | Draper Utah, United States, 84020West Virginia University School of Medicine | Morgantown West Virginia, United States, 26506Universitair Ziekenhuis Antwerpen - Ear-Nose-Throat Department | Edegem , Belgium, 2650UZ Gent - Ear-Nose-Throat Department | Ghent , Belgium, 9000UZ Leuven - Ear-Nose-Throat Department | Leuven , Belgium, 3000CHU de Liège - Ear-Nose-Throat Department | Liège , Belgium, 4000Uniklinik RWTH Aachen, Klinik für Hals-, Nasen-, Ohrenheilkunde und Plastische Kopf- und Halschirurgie | Aachen , Germany, 52074Praxis Bad Essen | Bad Essen , Germany, 49152Charité Universitätsmedizin Berlin | Berlin , Germany, 10117HNO Zentrum am Kudamm | Berlin , Germany, 10629HNO-Praxis Göttingen | Göttingen , Germany, 37073HNO Praxis am Neckar | Heidelberg , Germany, 69120HNO Praxis Dres. med. Florian Heimlich und Angelika Witzel-Heimlich | Heidelberg , Germany, 69126Universitätsklinikum Mannheim | Mannheim , Germany, 68167HNO Praxis Dr. med. Roger Fisher | Markkleeberg , Germany, 04416Klinikum der Universität München | München , Germany, 81377Universitätsklinikum Ulm, HNO-Klinik. Kopf-Hals-Chirurgie | Ulm , Germany, 89075U.O. di Otorinolaringoiatria Universitaria | Bari NAP, Italy, 70124Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico - U.O.S.D. Audiologia | Milan , Italy, 20122Unità Operativa di Otorinolaringoiatria | Piacenza , Italy, 29121Azienda Ospedaliera-Universitaria Sant' Andrea; Dipartimento Organi di Senso-U.O.C. Otorinolaringoiatria | Roma , Italy, 0018910 Wojskowy Szpital Kliniczny z Polikliniką SP ZOZ Oddział | Bydgoszcz , Poland, 85-681Centrum Medyczne ZDROWA | Krakow , Poland, 31-216Centrum Medyczne PROMED | Krakow , Poland, 31-411MT Medic Specjalistyczna Praktyka Lekarska Tomasz Stapiński | Krosno , Poland, 38-400ETG Łódź | Lodz , Poland, 90-302Centrum Słuchu i Mowy Sp. z o.o. | Nadarzyn , Poland, 05-830Kliniczny Szpital Wojewódzki Nr 1 im. Fryderyka Chopina | Rzeszów , Poland, 35-055Agencia Pública Empresarial Sanitaria Hospital de Poniente | El Ejido Almería, Spain, 04700Hospital Universitario de Getafe | Getafe Madrid, Spain, 28905Hospital Universitario Virgen de las Nieves | Granada , Spain, 18014Hospital Universitario Virgen Macarena | Seville , Spain, 41009Hacettepe Universitesi Tip Fakultesi Kulak Burun Bogaz Hastaliklari Anabilim Dali | Ankara , Turkey (Türkiye), 06100Baskent Universitesi Ankara Hastanesi, Kulak Burun Bogaz Hastaliklari Ana Bilim Dali | Ankara , Turkey (Türkiye), 06490Bayindir Hastanesi Sogutozu, Kulak Burun Bogaz Bas ve Boyun Cerrahisi Bolumu | Ankara , Turkey (Türkiye), 06530Uludag Universitesi Saglik Uygulama ve Arastirma Merkezi, Kulak Burum Bogaz Hastaliklari Ana Bilim Dali | Bursa , Turkey (Türkiye), 16059Istanbul Universitesi Istanbul Tip Fakultesi Kulak Burun Bogaz Hastaliklari Anabilim Dali | Istanbul , Turkey (Türkiye), 34093Acibadem Maslak Hastanesi Kulak Burun Bogaz Bolumu | Istanbul , Turkey (Türkiye), 34457Ege Universitesi Tip Fakultesi Kulak Burun Bogaz Hastaliklari Anabilim Dali | Izmir , Turkey (Türkiye), 35100Dokuz Eylul Universitesi Tip Fakultesi Tip Bilimleri Bolumu Kulak Burun Bogaz Anabilim Dali | Izmir , Turkey (Türkiye), 35340Ninewells Hospital and Medical School | Dundee Angus, United Kingdom, DD19SYRoyal Victoria Hospital | Belfast , United Kingdom, BT126BACambridge University Hospitals NHS Foundation Trust | Cambridge , United Kingdom, CB20QQUniversity Hospital of Wales | Cardiff , United Kingdom, CF144XWGloucestershire Royal Hospital | Gloucester , United Kingdom, GL13NNUniversity Hospitals of Leicester NHS Trust, Leicester Royal Infirmary | Leicester , United Kingdom, LE15WWGuy's and St Thomas' NHS Foundation Trust | London , United Kingdom, SE19RTManchester Head and Neck Centre, Peter Mount Building | Manchester , United Kingdom, M139WLNorfolk & Norwich University Hospital | Norwich , United Kingdom, NR47UYThe Royal Hallamshire Hospital | Sheffield , United Kingdom, S102JF
Study Documents (Full Text)
Documents provided by Otonomy, Inc.: Study Protocol and Statistical Analysis Plan  July 29, 2020