Phase 3 Study of OTO-104 in Subjects With Unilateral Meniere's Disease
- Registration Number
- NCT03664674
- Lead Sponsor
- Otonomy, Inc.
- Brief Summary
The purpose of this study is to evaluate the effectiveness of OTO-104 for the treatment of Meniere's disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 148
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description OTO-104 OTO-104 - placebo Placebo -
- Primary Outcome Measures
Name Time Method 28-Day Average DVD at Week 12 (Month 3) 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.
- Secondary Outcome Measures
Name Time Method Impact of Vertigo Experience on Daily Activities at Week 12 (Month 3) - The Number of Days Sick at Home or Bedridden 3 Months 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 3 months 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 4000 Hz From Baseline to Week 12 (Month 3) 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.
Audiometry - Shift in Air-Bone Gap at 1000 Hz From Baseline to Week 12 (Month 3) 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) 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.
Trial Locations
- Locations (65)
CHU de Liège - Ear-Nose-Throat Department
🇧🇪Liège, Belgium
Centrum Medyczne PROMED
🇵🇱Kraków, Poland
UZ Gent - Ear-Nose-Throat Department
🇧🇪Gent, Belgium
Dent Neurologic Institute
🇺🇸Amherst, New York, United States
HNO-Praxis Göttingen
🇩🇪Göttingen, Germany
Universitätsklinikum Ulm, HNO-Klinik. Kopf-Hals-Chirurgie
🇩🇪Ulm, Germany
UZ Leuven - Ear-Nose-Throat Department
🇧🇪Leuven, Belgium
U.O. di Otorinolaringoiatria Universitaria
🇮🇹Bari, NAP, Italy
West Virginia University School of Medicine
🇺🇸Morgantown, West Virginia, United States
Tandem Clinical Research
🇺🇸Marrero, Louisiana, United States
Uniklinik RWTH Aachen, Klinik für Hals-, Nasen-, Ohrenheilkunde und Plastische Kopf- und Halschirurgie
🇩🇪Aachen, Germany
HNO Praxis Dres. med. Florian Heimlich und Angelika Witzel-Heimlich
🇩🇪Heidelberg, Germany
10 Wojskowy Szpital Kliniczny z Polikliniką SP ZOZ Oddział
🇵🇱Bydgoszcz, Poland
MT Medic Specjalistyczna Praktyka Lekarska Tomasz Stapiński
🇵🇱Krosno, Poland
Kliniczny Szpital Wojewódzki Nr 1 im. Fryderyka Chopina
🇵🇱Rzeszów, Poland
Baskent Universitesi Ankara Hastanesi, Kulak Burun Bogaz Hastaliklari Ana Bilim Dali
🇹🇷Ankara, Turkey
Praxis Bad Essen
🇩🇪Bad Essen, Germany
Universitätsklinikum Mannheim
🇩🇪Mannheim, Germany
Charité Universitätsmedizin Berlin
🇩🇪Berlin, Germany
Central California Clinical Research
🇺🇸Fresno, California, United States
Michigan Ear Institute
🇺🇸Farmington Hills, Michigan, United States
Intermountain Ear, Nose & Throat Specialists
🇺🇸Draper, Utah, United States
Azienda Ospedaliera-Universitaria Sant' Andrea; Dipartimento Organi di Senso-U.O.C. Otorinolaringoiatria
🇮🇹Roma, Italy
HNO Praxis am Neckar
🇩🇪Heidelberg, Germany
Klinikum der Universität München
🇩🇪München, Germany
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico - U.O.S.D. Audiologia
🇮🇹Milano, Italy
Universitair Ziekenhuis Antwerpen - Ear-Nose-Throat Department
🇧🇪Edegem, Belgium
Ear Research Foundation
🇺🇸Sarasota, Florida, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Ear, Nose and Throat Associates of South Florida
🇺🇸Boynton Beach, Florida, United States
HNO Zentrum am Kudamm
🇩🇪Berlin, Germany
Agencia Pública Empresarial Sanitaria Hospital de Poniente
🇪🇸El Ejido, Almería, Spain
New York Eye and Ear Infirmary of Mount Sinai
🇺🇸New York, New York, United States
Centrum Medyczne ZDROWA
🇵🇱Kraków, Poland
Centrum Słuchu i Mowy Sp. z o.o.
🇵🇱Nadarzyn, Poland
ETG Łódź
🇵🇱Łódź, Poland
Dokuz Eylul Universitesi Tip Fakultesi Tip Bilimleri Bolumu Kulak Burun Bogaz Anabilim Dali
🇹🇷İzmir, Turkey
Gloucestershire Royal Hospital
🇬🇧Gloucester, United Kingdom
Royal Victoria Hospital
🇬🇧Belfast, United Kingdom
Hospital Universitario Virgen de las Nieves
🇪🇸Granada, Spain
Hospital Universitario de Getafe
🇪🇸Getafe, Madrid, Spain
Uludag Universitesi Saglik Uygulama ve Arastirma Merkezi, Kulak Burum Bogaz Hastaliklari Ana Bilim Dali
🇹🇷Bursa, Turkey
HNO Praxis Dr. med. Roger Fisher
🇩🇪Markkleeberg, Germany
Hospital Universitario Virgen Macarena
🇪🇸Sevilla, Spain
University Hospital of Wales
🇬🇧Cardiff, United Kingdom
Saint Louis University
🇺🇸Saint Louis, Missouri, United States
Charlotte Eye Ear Nose & Throat Associates, P.A.
🇺🇸Matthews, North Carolina, United States
Unità Operativa di Otorinolaringoiatria
🇮🇹Piacenza, Italy
Hacettepe Universitesi Tip Fakultesi Kulak Burun Bogaz Hastaliklari Anabilim Dali
🇹🇷Ankara, Turkey
Bayindir Hastanesi Sogutozu, Kulak Burun Bogaz Bas ve Boyun Cerrahisi Bolumu
🇹🇷Ankara, Turkey
Istanbul Universitesi Istanbul Tip Fakultesi Kulak Burun Bogaz Hastaliklari Anabilim Dali
🇹🇷Istanbul, Turkey
Acibadem Maslak Hastanesi Kulak Burun Bogaz Bolumu
🇹🇷Istanbul, Turkey
Ege Universitesi Tip Fakultesi Kulak Burun Bogaz Hastaliklari Anabilim Dali
🇹🇷İzmir, Turkey
Ninewells Hospital and Medical School
🇬🇧Dundee, Angus, United Kingdom
Cambridge University Hospitals NHS Foundation Trust
🇬🇧Cambridge, United Kingdom
Manchester Head and Neck Centre, Peter Mount Building
🇬🇧Manchester, United Kingdom
University Hospitals of Leicester NHS Trust, Leicester Royal Infirmary
🇬🇧Leicester, United Kingdom
The Royal Hallamshire Hospital
🇬🇧Sheffield, United Kingdom
Norfolk & Norwich University Hospital
🇬🇧Norwich, United Kingdom
Colorado ENT & Allergy
🇺🇸Colorado Springs, Colorado, United States
University of Colorado School of Medicine
🇺🇸Aurora, Colorado, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
Piedmont Ear, Nose, and Throat Associates, PA
🇺🇸Winston-Salem, North Carolina, United States
Medical University of South Carolina, Department of Otolaryngology
🇺🇸Charleston, South Carolina, United States
Guy's and St Thomas' NHS Foundation Trust
🇬🇧London, United Kingdom