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

Primary Purpose

Meniere Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
OTO-104
Placebo
Sponsored by
Otonomy, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Meniere Disease focused on measuring Meniere's Disease, Vertigo, Endolymphatic Hydrops, Labyrinth Diseases, Ear Diseases, Otorhinolaryngologic Diseases

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Central California Clinical Research
  • University of Colorado School of Medicine
  • Colorado ENT & Allergy
  • Yale University School of Medicine
  • Ear, Nose and Throat Associates of South Florida
  • Ear Research Foundation
  • Tandem Clinical Research
  • Michigan Ear Institute
  • Saint Louis University
  • Dent Neurologic Institute
  • New York Eye and Ear Infirmary of Mount Sinai
  • Charlotte Eye Ear Nose & Throat Associates, P.A.
  • Piedmont Ear, Nose, and Throat Associates, PA
  • Medical University of South Carolina, Department of Otolaryngology
  • Vanderbilt University Medical Center
  • Intermountain Ear, Nose & Throat Specialists
  • West Virginia University School of Medicine
  • Universitair Ziekenhuis Antwerpen - Ear-Nose-Throat Department
  • UZ Gent - Ear-Nose-Throat Department
  • UZ Leuven - Ear-Nose-Throat Department
  • CHU de Liège - Ear-Nose-Throat Department
  • Uniklinik RWTH Aachen, Klinik für Hals-, Nasen-, Ohrenheilkunde und Plastische Kopf- und Halschirurgie
  • Praxis Bad Essen
  • Charité Universitätsmedizin Berlin
  • HNO Zentrum am Kudamm
  • HNO-Praxis Göttingen
  • HNO Praxis am Neckar
  • HNO Praxis Dres. med. Florian Heimlich und Angelika Witzel-Heimlich
  • Universitätsklinikum Mannheim
  • HNO Praxis Dr. med. Roger Fisher
  • Klinikum der Universität München
  • Universitätsklinikum Ulm, HNO-Klinik. Kopf-Hals-Chirurgie
  • U.O. di Otorinolaringoiatria Universitaria
  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico - U.O.S.D. Audiologia
  • Unità Operativa di Otorinolaringoiatria
  • Azienda Ospedaliera-Universitaria Sant' Andrea; Dipartimento Organi di Senso-U.O.C. Otorinolaringoiatria
  • 10 Wojskowy Szpital Kliniczny z Polikliniką SP ZOZ Oddział
  • Centrum Medyczne ZDROWA
  • Centrum Medyczne PROMED
  • MT Medic Specjalistyczna Praktyka Lekarska Tomasz Stapiński
  • Centrum Słuchu i Mowy Sp. z o.o.
  • Kliniczny Szpital Wojewódzki Nr 1 im. Fryderyka Chopina
  • ETG Łódź
  • Agencia Pública Empresarial Sanitaria Hospital de Poniente
  • Hospital Universitario de Getafe
  • Hospital Universitario Virgen de las Nieves
  • Hospital Universitario Virgen Macarena
  • Hacettepe Universitesi Tip Fakultesi Kulak Burun Bogaz Hastaliklari Anabilim Dali
  • Baskent Universitesi Ankara Hastanesi, Kulak Burun Bogaz Hastaliklari Ana Bilim Dali
  • Bayindir Hastanesi Sogutozu, Kulak Burun Bogaz Bas ve Boyun Cerrahisi Bolumu
  • Uludag Universitesi Saglik Uygulama ve Arastirma Merkezi, Kulak Burum Bogaz Hastaliklari Ana Bilim Dali
  • Istanbul Universitesi Istanbul Tip Fakultesi Kulak Burun Bogaz Hastaliklari Anabilim Dali
  • Acibadem Maslak Hastanesi Kulak Burun Bogaz Bolumu
  • Ege Universitesi Tip Fakultesi Kulak Burun Bogaz Hastaliklari Anabilim Dali
  • Dokuz Eylul Universitesi Tip Fakultesi Tip Bilimleri Bolumu Kulak Burun Bogaz Anabilim Dali
  • Ninewells Hospital and Medical School
  • Royal Victoria Hospital
  • Cambridge University Hospitals NHS Foundation Trust
  • University Hospital of Wales
  • Gloucestershire Royal Hospital
  • University Hospitals of Leicester NHS Trust, Leicester Royal Infirmary
  • Guy's and St Thomas' NHS Foundation Trust
  • Manchester Head and Neck Centre, Peter Mount Building
  • Norfolk & Norwich University Hospital
  • The Royal Hallamshire Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

OTO-104

placebo

Arm Description

Outcomes

Primary Outcome Measures

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

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.
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.
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.
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.
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.

Full Information

First Posted
August 31, 2018
Last Updated
November 15, 2022
Sponsor
Otonomy, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03664674
Brief Title
Phase 3 Study of OTO-104 in Subjects With Unilateral Meniere's Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
August 27, 2018 (Actual)
Primary Completion Date
December 22, 2020 (Actual)
Study Completion Date
December 22, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otonomy, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the effectiveness of OTO-104 for the treatment of Meniere's disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meniere Disease
Keywords
Meniere's Disease, Vertigo, Endolymphatic Hydrops, Labyrinth Diseases, Ear Diseases, Otorhinolaryngologic Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomized, Double-blind, Placebo-controlled, Multicenter
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
148 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OTO-104
Arm Type
Experimental
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
OTO-104
Intervention Description
Single intratympanic injection of 12 mg dexamethasone
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Single intratympanic injection of placebo
Primary Outcome Measure Information:
Title
28-Day Average DVD at Week 12 (Month 3)
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Impact of Vertigo Experience on Daily Activities at Week 12 (Month 3) - The Number of Days Sick at Home or Bedridden
Description
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.
Time Frame
3 Months
Title
Otoscopic Examination - Presence of Perforation in the Treated Ear at Week 12 (Month 3) Final Visit
Description
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.
Time Frame
3 months
Title
Audiometry - Shift in Air-Bone Gap at 1000 Hz From Baseline to Week 12 (Month 3)
Description
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.
Time Frame
Week 12 (Month 3)
Title
Audiometry - Shift in Air-Bone Gap at 2000 Hz From Baseline to Week 12 (Month 3)
Description
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.
Time Frame
Week 12 (Month 3)
Title
Audiometry - Shift in Air-Bone Gap at 4000 Hz From Baseline to Week 12 (Month 3)
Description
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.
Time Frame
Week 12 (Month 3)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Central California Clinical Research
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
University of Colorado School of Medicine
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Colorado ENT & Allergy
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Ear, Nose and Throat Associates of South Florida
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33426
Country
United States
Facility Name
Ear Research Foundation
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Tandem Clinical Research
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Facility Name
Michigan Ear Institute
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
Saint Louis University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Dent Neurologic Institute
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
Country
United States
Facility Name
New York Eye and Ear Infirmary of Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Charlotte Eye Ear Nose & Throat Associates, P.A.
City
Matthews
State/Province
North Carolina
ZIP/Postal Code
28105
Country
United States
Facility Name
Piedmont Ear, Nose, and Throat Associates, PA
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Medical University of South Carolina, Department of Otolaryngology
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Intermountain Ear, Nose & Throat Specialists
City
Draper
State/Province
Utah
ZIP/Postal Code
84020
Country
United States
Facility Name
West Virginia University School of Medicine
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Universitair Ziekenhuis Antwerpen - Ear-Nose-Throat Department
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
UZ Gent - Ear-Nose-Throat Department
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
UZ Leuven - Ear-Nose-Throat Department
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
CHU de Liège - Ear-Nose-Throat Department
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Uniklinik RWTH Aachen, Klinik für Hals-, Nasen-, Ohrenheilkunde und Plastische Kopf- und Halschirurgie
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Praxis Bad Essen
City
Bad Essen
ZIP/Postal Code
49152
Country
Germany
Facility Name
Charité Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
HNO Zentrum am Kudamm
City
Berlin
ZIP/Postal Code
10629
Country
Germany
Facility Name
HNO-Praxis Göttingen
City
Göttingen
ZIP/Postal Code
37073
Country
Germany
Facility Name
HNO Praxis am Neckar
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
HNO Praxis Dres. med. Florian Heimlich und Angelika Witzel-Heimlich
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Facility Name
Universitätsklinikum Mannheim
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
HNO Praxis Dr. med. Roger Fisher
City
Markkleeberg
ZIP/Postal Code
04416
Country
Germany
Facility Name
Klinikum der Universität München
City
München
ZIP/Postal Code
81377
Country
Germany
Facility Name
Universitätsklinikum Ulm, HNO-Klinik. Kopf-Hals-Chirurgie
City
Ulm
ZIP/Postal Code
89075
Country
Germany
Facility Name
U.O. di Otorinolaringoiatria Universitaria
City
Bari
State/Province
NAP
ZIP/Postal Code
70124
Country
Italy
Facility Name
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico - U.O.S.D. Audiologia
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Unità Operativa di Otorinolaringoiatria
City
Piacenza
ZIP/Postal Code
29121
Country
Italy
Facility Name
Azienda Ospedaliera-Universitaria Sant' Andrea; Dipartimento Organi di Senso-U.O.C. Otorinolaringoiatria
City
Roma
ZIP/Postal Code
00189
Country
Italy
Facility Name
10 Wojskowy Szpital Kliniczny z Polikliniką SP ZOZ Oddział
City
Bydgoszcz
ZIP/Postal Code
85-681
Country
Poland
Facility Name
Centrum Medyczne ZDROWA
City
Kraków
ZIP/Postal Code
31-216
Country
Poland
Facility Name
Centrum Medyczne PROMED
City
Kraków
ZIP/Postal Code
31-411
Country
Poland
Facility Name
MT Medic Specjalistyczna Praktyka Lekarska Tomasz Stapiński
City
Krosno
ZIP/Postal Code
38-400
Country
Poland
Facility Name
Centrum Słuchu i Mowy Sp. z o.o.
City
Nadarzyn
ZIP/Postal Code
05-830
Country
Poland
Facility Name
Kliniczny Szpital Wojewódzki Nr 1 im. Fryderyka Chopina
City
Rzeszów
ZIP/Postal Code
35-055
Country
Poland
Facility Name
ETG Łódź
City
Łódź
ZIP/Postal Code
90-302
Country
Poland
Facility Name
Agencia Pública Empresarial Sanitaria Hospital de Poniente
City
El Ejido
State/Province
Almería
ZIP/Postal Code
04700
Country
Spain
Facility Name
Hospital Universitario de Getafe
City
Getafe
State/Province
Madrid
ZIP/Postal Code
28905
Country
Spain
Facility Name
Hospital Universitario Virgen de las Nieves
City
Granada
ZIP/Postal Code
18014
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hacettepe Universitesi Tip Fakultesi Kulak Burun Bogaz Hastaliklari Anabilim Dali
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Baskent Universitesi Ankara Hastanesi, Kulak Burun Bogaz Hastaliklari Ana Bilim Dali
City
Ankara
ZIP/Postal Code
06490
Country
Turkey
Facility Name
Bayindir Hastanesi Sogutozu, Kulak Burun Bogaz Bas ve Boyun Cerrahisi Bolumu
City
Ankara
ZIP/Postal Code
06530
Country
Turkey
Facility Name
Uludag Universitesi Saglik Uygulama ve Arastirma Merkezi, Kulak Burum Bogaz Hastaliklari Ana Bilim Dali
City
Bursa
ZIP/Postal Code
16059
Country
Turkey
Facility Name
Istanbul Universitesi Istanbul Tip Fakultesi Kulak Burun Bogaz Hastaliklari Anabilim Dali
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Facility Name
Acibadem Maslak Hastanesi Kulak Burun Bogaz Bolumu
City
Istanbul
ZIP/Postal Code
34457
Country
Turkey
Facility Name
Ege Universitesi Tip Fakultesi Kulak Burun Bogaz Hastaliklari Anabilim Dali
City
İzmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Dokuz Eylul Universitesi Tip Fakultesi Tip Bilimleri Bolumu Kulak Burun Bogaz Anabilim Dali
City
İzmir
ZIP/Postal Code
35340
Country
Turkey
Facility Name
Ninewells Hospital and Medical School
City
Dundee
State/Province
Angus
ZIP/Postal Code
DD19SY
Country
United Kingdom
Facility Name
Royal Victoria Hospital
City
Belfast
ZIP/Postal Code
BT126BA
Country
United Kingdom
Facility Name
Cambridge University Hospitals NHS Foundation Trust
City
Cambridge
ZIP/Postal Code
CB20QQ
Country
United Kingdom
Facility Name
University Hospital of Wales
City
Cardiff
ZIP/Postal Code
CF144XW
Country
United Kingdom
Facility Name
Gloucestershire Royal Hospital
City
Gloucester
ZIP/Postal Code
GL13NN
Country
United Kingdom
Facility Name
University Hospitals of Leicester NHS Trust, Leicester Royal Infirmary
City
Leicester
ZIP/Postal Code
LE15WW
Country
United Kingdom
Facility Name
Guy's and St Thomas' NHS Foundation Trust
City
London
ZIP/Postal Code
SE19RT
Country
United Kingdom
Facility Name
Manchester Head and Neck Centre, Peter Mount Building
City
Manchester
ZIP/Postal Code
M139WL
Country
United Kingdom
Facility Name
Norfolk & Norwich University Hospital
City
Norwich
ZIP/Postal Code
NR47UY
Country
United Kingdom
Facility Name
The Royal Hallamshire Hospital
City
Sheffield
ZIP/Postal Code
S102JF
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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