Clinical trial NCT03664674: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Meniere Disease
Keywords: Meniere's Disease
Vertigo
Endolymphatic Hydrops
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Lead sponsor: Otonomy, Inc.
Sponsor class: INDUSTRY
First posted: 2018-09-10
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, Double-blind, Placebo-controlled, Multicenter
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: 28-Day Average DVD at Week 12 (Month 3)
timeFrame: 3 months
Secondary outcomes:
measure: Impact of Vertigo Experience on Daily Activities at Week 12 (Month 3) - The Number of Days Sick at Home or Bedridden
timeFrame: 3 Months
measure: Otoscopic Examination - Presence of Perforation in the Treated Ear at Week 12 (Month 3) Final Visit
timeFrame: 3 months
measure: Audiometry - Shift in Air-Bone Gap at 1000 Hz From Baseline to Week 12 (Month 3)
timeFrame: Week 12 (Month 3)
measure: Audiometry - Shift in Air-Bone Gap at 2000 Hz From Baseline to Week 12 (Month 3)
timeFrame: Week 12 (Month 3)
measure: Audiometry - Shift in Air-Bone Gap at 4000 Hz From Baseline to Week 12 (Month 3)
timeFrame: Week 12 (Month 3)
Other outcomes:
Locations:
city: Fresno
country: United States
facility: Central California Clinical Research
state: California
city: Aurora
country: United States
facility: University of Colorado School of Medicine
state: Colorado
city: Colorado Springs
country: United States
facility: Colorado ENT & Allergy
state: Colorado
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Boynton Beach
country: United States
facility: Ear, Nose and Throat Associates of South Florida
state: Florida
city: Sarasota
country: United States
facility: Ear Research Foundation
state: Florida
city: Marrero
country: United States
facility: Tandem Clinical Research
state: Louisiana
city: Farmington Hills
country: United States
facility: Michigan Ear Institute
state: Michigan
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
city: Amherst
country: United States
facility: Dent Neurologic Institute
state: New York
city: New York
country: United States
facility: New York Eye and Ear Infirmary of Mount Sinai
state: New York
city: Matthews
country: United States
facility: Charlotte Eye Ear Nose & Throat Associates, P.A.
state: North Carolina
city: Winston-Salem
country: United States
facility: Piedmont Ear, Nose, and Throat Associates, PA
state: North Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina, Department of Otolaryngology
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Draper
country: United States
facility: Intermountain Ear, Nose & Throat Specialists
state: Utah
city: Morgantown
country: United States
facility: West Virginia University School of Medicine
state: West Virginia
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen - Ear-Nose-Throat Department
city: Gent
country: Belgium
facility: UZ Gent - Ear-Nose-Throat Department
city: Leuven
country: Belgium
facility: UZ Leuven - Ear-Nose-Throat Department
city: Liège
country: Belgium
facility: CHU de Liège - Ear-Nose-Throat Department
city: Aachen
country: Germany
facility: Uniklinik RWTH Aachen, Klinik für Hals-, Nasen-, Ohrenheilkunde und Plastische Kopf- und Halschirurgie
city: Bad Essen
country: Germany
facility: Praxis Bad Essen
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin
city: Berlin
country: Germany
facility: HNO Zentrum am Kudamm
city: Göttingen
country: Germany
facility: HNO-Praxis Göttingen
city: Heidelberg
country: Germany
facility: HNO Praxis am Neckar
city: Heidelberg
country: Germany
facility: HNO Praxis Dres. med. Florian Heimlich und Angelika Witzel-Heimlich
city: Mannheim
country: Germany
facility: Universitätsklinikum Mannheim
city: Markkleeberg
country: Germany
facility: HNO Praxis Dr. med. Roger Fisher
city: München
country: Germany
facility: Klinikum der Universität München
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm, HNO-Klinik. Kopf-Hals-Chirurgie
city: Bari
country: Italy
facility: U.O. di Otorinolaringoiatria Universitaria
state: NAP
city: Milano
country: Italy
facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico - U.O.S.D. Audiologia
city: Piacenza
country: Italy
facility: Unità Operativa di Otorinolaringoiatria
city: Roma
country: Italy
facility: Azienda Ospedaliera-Universitaria Sant' Andrea; Dipartimento Organi di Senso-U.O.C. Otorinolaringoiatria
city: Bydgoszcz
country: Poland
facility: 10 Wojskowy Szpital Kliniczny z Polikliniką SP ZOZ Oddział
city: Kraków
country: Poland
facility: Centrum Medyczne ZDROWA
city: Kraków
country: Poland
facility: Centrum Medyczne PROMED
city: Krosno
country: Poland
facility: MT Medic Specjalistyczna Praktyka Lekarska Tomasz Stapiński
city: Nadarzyn
country: Poland
facility: Centrum Słuchu i Mowy Sp. z o.o.
city: Rzeszów
country: Poland
facility: Kliniczny Szpital Wojewódzki Nr 1 im. Fryderyka Chopina
city: Łódź
country: Poland
facility: ETG Łódź
city: El Ejido
country: Spain
facility: Agencia Pública Empresarial Sanitaria Hospital de Poniente
state: Almería
city: Getafe
country: Spain
facility: Hospital Universitario de Getafe
state: Madrid
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Ankara
country: Turkey
facility: Hacettepe Universitesi Tip Fakultesi Kulak Burun Bogaz Hastaliklari Anabilim Dali
city: Ankara
country: Turkey
facility: Baskent Universitesi Ankara Hastanesi, Kulak Burun Bogaz Hastaliklari Ana Bilim Dali
city: Ankara
country: Turkey
facility: Bayindir Hastanesi Sogutozu, Kulak Burun Bogaz Bas ve Boyun Cerrahisi Bolumu
city: Bursa
country: Turkey
facility: Uludag Universitesi Saglik Uygulama ve Arastirma Merkezi, Kulak Burum Bogaz Hastaliklari Ana Bilim Dali
city: Istanbul
country: Turkey
facility: Istanbul Universitesi Istanbul Tip Fakultesi Kulak Burun Bogaz Hastaliklari Anabilim Dali
city: Istanbul
country: Turkey
facility: Acibadem Maslak Hastanesi Kulak Burun Bogaz Bolumu
city: İzmir
country: Turkey
facility: Ege Universitesi Tip Fakultesi Kulak Burun Bogaz Hastaliklari Anabilim Dali
city: İzmir
country: Turkey
facility: Dokuz Eylul Universitesi Tip Fakultesi Tip Bilimleri Bolumu Kulak Burun Bogaz Anabilim Dali
city: Dundee
country: United Kingdom
facility: Ninewells Hospital and Medical School
state: Angus
city: Belfast
country: United Kingdom
facility: Royal Victoria Hospital
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Foundation Trust
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales
city: Gloucester
country: United Kingdom
facility: Gloucestershire Royal Hospital
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester NHS Trust, Leicester Royal Infirmary
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust
city: Manchester
country: United Kingdom
facility: Manchester Head and Neck Centre, Peter Mount Building
city: Norwich
country: United Kingdom
facility: Norfolk & Norwich University Hospital
city: Sheffield
country: United Kingdom
facility: The Royal Hallamshire Hospital
Study officials:
References: