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

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.

Study Overview

• Status: Completed
• Conditions: Meniere Disease
• Intervention / Treatment: Drug: Placebo; Drug: OTO-104

• Study Type: Interventional
• Enrollment (Actual): 148
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Edegem, Belgium, 2650
    • Universitair Ziekenhuis Antwerpen - Ear-Nose-Throat Department
  • Gent, Belgium, 9000
    • UZ Gent - Ear-Nose-Throat Department
  • Leuven, Belgium, 3000
    • UZ Leuven - Ear-Nose-Throat Department
  • Liège, Belgium, 4000
    • CHU de Liège - Ear-Nose-Throat Department
• Germany
  • Aachen, Germany, 52074
    • Uniklinik RWTH Aachen, Klinik für Hals-, Nasen-, Ohrenheilkunde und Plastische Kopf- und Halschirurgie
  • Bad Essen, Germany, 49152
    • Praxis Bad Essen
  • Berlin, Germany, 10117
    • Charité Universitätsmedizin Berlin
  • Berlin, Germany, 10629
    • HNO Zentrum am Kudamm
  • Göttingen, Germany, 37073
    • HNO-Praxis Göttingen
  • Heidelberg, Germany, 69120
    • HNO Praxis am Neckar
  • Heidelberg, Germany, 69126
    • HNO Praxis Dres. med. Florian Heimlich und Angelika Witzel-Heimlich
  • Mannheim, Germany, 68167
    • Universitätsklinikum Mannheim
  • Markkleeberg, Germany, 04416
    • HNO Praxis Dr. med. Roger Fisher
  • München, Germany, 81377
    • Klinikum der Universität München
  • Ulm, Germany, 89075
    • Universitätsklinikum Ulm, HNO-Klinik. Kopf-Hals-Chirurgie
• Italy
  • Milano, Italy, 20122
    • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico - U.O.S.D. Audiologia
  • Piacenza, Italy, 29121
    • Unità Operativa di Otorinolaringoiatria
  • Roma, Italy, 00189
    • Azienda Ospedaliera-Universitaria Sant' Andrea; Dipartimento Organi di Senso-U.O.C. Otorinolaringoiatria
  • NAP
    • Bari, NAP, Italy, 70124
      • U.O. di Otorinolaringoiatria Universitaria
• Poland
  • Bydgoszcz, Poland, 85-681
    • 10 Wojskowy Szpital Kliniczny z Polikliniką SP ZOZ Oddział
  • Kraków, Poland, 31-216
    • Centrum Medyczne Zdrowa
  • Kraków, Poland, 31-411
    • Centrum Medyczne Promed
  • Krosno, Poland, 38-400
    • MT Medic Specjalistyczna Praktyka Lekarska Tomasz Stapinski
  • Nadarzyn, Poland, 05-830
    • CENTRUM SŁUCHU I MOWY Sp. z o.o.
  • Rzeszów, Poland, 35-055
    • Kliniczny Szpital Wojewódzki Nr 1 im. Fryderyka Chopina
  • Łódź, Poland, 90-302
    • ETG Łódz
• Spain
  • Granada, Spain, 18014
    • Hospital Universitario Virgen de las Nieves
  • Sevilla, Spain, 41009
    • Hospital Universitario Virgen Macarena
  • Almería
    • El Ejido, Almería, Spain, 04700
      • Agencia Pública Empresarial Sanitaria Hospital de Poniente
  • Madrid
    • Getafe, Madrid, Spain, 28905
      • Hospital Universitario de Getafe
• Turkey
  • Ankara, Turkey, 06100
    • Hacettepe Universitesi Tip Fakultesi Kulak Burun Bogaz Hastaliklari Anabilim Dali
  • Ankara, Turkey, 06490
    • Baskent Universitesi Ankara Hastanesi, Kulak Burun Bogaz Hastaliklari Ana Bilim Dali
  • Ankara, Turkey, 06530
    • Bayindir Hastanesi Sogutozu, Kulak Burun Bogaz Bas ve Boyun Cerrahisi Bolumu
  • Bursa, Turkey, 16059
    • Uludag Universitesi Saglik Uygulama ve Arastirma Merkezi, Kulak Burum Bogaz Hastaliklari Ana Bilim Dali
  • Istanbul, Turkey, 34093
    • Istanbul Universitesi Istanbul Tip Fakultesi Kulak Burun Bogaz Hastaliklari Anabilim Dali
  • Istanbul, Turkey, 34457
    • Acibadem Maslak Hastanesi Kulak Burun Bogaz Bolumu
  • İzmir, Turkey, 35100
    • Ege Universitesi Tip Fakultesi Kulak Burun Bogaz Hastaliklari Anabilim Dali
  • İzmir, Turkey, 35340
    • Dokuz Eylul Universitesi Tip Fakultesi Tip Bilimleri Bolumu Kulak Burun Bogaz Anabilim Dali
• United Kingdom
  • Belfast, United Kingdom, BT126BA
    • Royal Victoria Hospital
  • Cambridge, United Kingdom, CB20QQ
    • Cambridge University Hospitals NHS Foundation Trust
  • Cardiff, United Kingdom, CF144XW
    • University Hospital of Wales
  • Gloucester, United Kingdom, GL13NN
    • Gloucestershire Royal Hospital
  • Leicester, United Kingdom, LE15WW
    • University Hospitals of Leicester NHS Trust, Leicester Royal Infirmary
  • London, United Kingdom, SE19RT
    • Guy's and St Thomas' NHS Foundation Trust
  • Manchester, United Kingdom, M139WL
    • Manchester Head and Neck Centre, Peter Mount Building
  • Norwich, United Kingdom, NR47UY
    • Norfolk & Norwich University Hospital
  • Sheffield, United Kingdom, S102JF
    • The Royal Hallamshire Hospital
  • Angus
    • Dundee, Angus, United Kingdom, DD19SY
      • Ninewells Hospital and Medical School
• United States
  • California
    • Fresno, California, United States, 93720
      • Central California Clinical Research
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado School of Medicine
    • Colorado Springs, Colorado, United States, 80909
      • Colorado ENT & Allergy
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale University School Of Medicine
  • Florida
    • Boynton Beach, Florida, United States, 33426
      • Ear, Nose and Throat Associates of South Florida
    • Sarasota, Florida, United States, 34239
      • Ear Research Foundation
  • Louisiana
    • Marrero, Louisiana, United States, 70072
      • Tandem Clinical Research
  • Michigan
    • Farmington Hills, Michigan, United States, 48334
      • Michigan Ear Institute
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Saint Louis University
  • New York
    • Amherst, New York, United States, 14226
      • Dent Neurologic Institute
    • New York, New York, United States, 10003
      • New York Eye and Ear Infirmary of Mount Sinai
  • North Carolina
    • Matthews, North Carolina, United States, 28105
      • Charlotte Eye Ear Nose & Throat Associates, P.A.
    • Winston-Salem, North Carolina, United States, 27103
      • Piedmont Ear, Nose, and Throat Associates, PA
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina, Department of Otolaryngology
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Utah
    • Draper, Utah, United States, 84020
      • Intermountain Ear, Nose & Throat Specialists
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • West Virginia University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Drug: Placebo; Single intratympanic injection of placebo
Experimental: OTO-104	Drug: OTO-104; Single intratympanic injection of 12 mg dexamethasone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	Week 12 (Month 3)

Collaborators and Investigators

• Sponsor: Otonomy, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2018
• Primary Completion (Actual): December 22, 2020
• Study Completion (Actual): December 22, 2020

Study Registration Dates

• First Submitted: August 31, 2018
• First Submitted That Met QC Criteria: September 6, 2018
• First Posted (Actual): September 10, 2018

Study Record Updates

• Last Update Posted (Estimate): December 7, 2022
• Last Update Submitted That Met QC Criteria: November 15, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Vertigo; Ear Diseases; Otorhinolaryngologic Diseases; Meniere's Disease; Endolymphatic Hydrops; Labyrinth Diseases
• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Labyrinth Diseases; Ear Diseases; Endolymphatic Hydrops; Meniere Disease
• Other Study ID Numbers: 104-201811

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No