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

NCT03664674 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 104-201811
• Study Type: interventional
• Target: 148
• Locations: 8 countries
• Sites: 65

Brief Summary

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

Conditions

Meniere Disease

Keywords

Meniere's Disease; Vertigo; Endolymphatic Hydrops; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases

Outcome Measures

Primary Outcomes (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.

  3 months

Secondary Outcomes (5)

• Impact of Vertigo Experience on Daily Activities at Week 12 (Month 3) - The Number of Days Sick at Home or Bedridden

  3 Months

• Otoscopic Examination - Presence of Perforation in the Treated Ear at Week 12 (Month 3) Final Visit

  3 months

• Audiometry - Shift in Air-Bone Gap at 1000 Hz From Baseline to Week 12 (Month 3)

  Week 12 (Month 3)

• Audiometry - Shift in Air-Bone Gap at 2000 Hz From Baseline to Week 12 (Month 3)

  Week 12 (Month 3)

• Audiometry - Shift in Air-Bone Gap at 4000 Hz From Baseline to Week 12 (Month 3)

  Week 12 (Month 3)

Study Arms (2)

OTO-104

EXPERIMENTAL

Drug: OTO-104

placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

OTO-104 DRUG

Single intratympanic injection of 12 mg dexamethasone

OTO-104

Placebo DRUG

Single intratympanic injection of placebo

placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Otonomy, Inc.: lead

Study Sites (65)

Central California Clinical Research

Fresno, California, 93720, United States

Location

University of Colorado School of Medicine

Aurora, Colorado, 80045, United States

Location

Colorado ENT & Allergy

Colorado Springs, Colorado, 80909, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06510, United States

Location

Ear, Nose and Throat Associates of South Florida

Boynton Beach, Florida, 33426, United States

Location

Ear Research Foundation

Sarasota, Florida, 34239, United States

Location

Tandem Clinical Research

Marrero, Louisiana, 70072, United States

Location

Michigan Ear Institute

Farmington Hills, Michigan, 48334, United States

Location

Saint Louis University

St Louis, Missouri, 63110, United States

Location

Dent Neurologic Institute

Amherst, New York, 14226, United States

Location

New York Eye and Ear Infirmary of Mount Sinai

New York, New York, 10003, United States

Location

Charlotte Eye Ear Nose & Throat Associates, P.A.

Matthews, North Carolina, 28105, United States

Location

Piedmont Ear, Nose, and Throat Associates, PA

Winston-Salem, North Carolina, 27103, United States

Location

Medical University of South Carolina, Department of Otolaryngology

Charleston, South Carolina, 29425, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Intermountain Ear, Nose & Throat Specialists

Draper, Utah, 84020, United States

Location

West Virginia University School of Medicine

Morgantown, West Virginia, 26506, United States

Location

Universitair Ziekenhuis Antwerpen - Ear-Nose-Throat Department

Edegem, 2650, Belgium

Location

UZ Gent - Ear-Nose-Throat Department

Ghent, 9000, Belgium

Location

UZ Leuven - Ear-Nose-Throat Department

Leuven, 3000, Belgium

Location

CHU de Liège - Ear-Nose-Throat Department

Liège, 4000, Belgium

Location

Uniklinik RWTH Aachen, Klinik für Hals-, Nasen-, Ohrenheilkunde und Plastische Kopf- und Halschirurgie

Aachen, 52074, Germany

Location

Praxis Bad Essen

Bad Essen, 49152, Germany

Location

Charité Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

HNO Zentrum am Kudamm

Berlin, 10629, Germany

Location

HNO-Praxis Göttingen

Göttingen, 37073, Germany

Location

HNO Praxis am Neckar

Heidelberg, 69120, Germany

Location

HNO Praxis Dres. med. Florian Heimlich und Angelika Witzel-Heimlich

Heidelberg, 69126, Germany

Location

Universitätsklinikum Mannheim

Mannheim, 68167, Germany

Location

HNO Praxis Dr. med. Roger Fisher

Markkleeberg, 04416, Germany

Location

Klinikum der Universität München

München, 81377, Germany

Location

Universitätsklinikum Ulm, HNO-Klinik. Kopf-Hals-Chirurgie

Ulm, 89075, Germany

Location

U.O. di Otorinolaringoiatria Universitaria

Bari, NAP, 70124, Italy

Location

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico - U.O.S.D. Audiologia

Milan, 20122, Italy

Location

Unità Operativa di Otorinolaringoiatria

Piacenza, 29121, Italy

Location

Azienda Ospedaliera-Universitaria Sant' Andrea; Dipartimento Organi di Senso-U.O.C. Otorinolaringoiatria

Roma, 00189, Italy

Location

10 Wojskowy Szpital Kliniczny z Polikliniką SP ZOZ Oddział

Bydgoszcz, 85-681, Poland

Location

Centrum Medyczne ZDROWA

Krakow, 31-216, Poland

Location

Centrum Medyczne PROMED

Krakow, 31-411, Poland

Location

MT Medic Specjalistyczna Praktyka Lekarska Tomasz Stapiński

Krosno, 38-400, Poland

Location

ETG Łódź

Lodz, 90-302, Poland

Location

Centrum Słuchu i Mowy Sp. z o.o.

Nadarzyn, 05-830, Poland

Location

Kliniczny Szpital Wojewódzki Nr 1 im. Fryderyka Chopina

Rzeszów, 35-055, Poland

Location

Agencia Pública Empresarial Sanitaria Hospital de Poniente

El Ejido, Almería, 04700, Spain

Location

Hospital Universitario de Getafe

Getafe, Madrid, 28905, Spain

Location

Hospital Universitario Virgen de las Nieves

Granada, 18014, Spain

Location

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

Location

Hacettepe Universitesi Tip Fakultesi Kulak Burun Bogaz Hastaliklari Anabilim Dali

Ankara, 06100, Turkey (Türkiye)

Location

Baskent Universitesi Ankara Hastanesi, Kulak Burun Bogaz Hastaliklari Ana Bilim Dali

Ankara, 06490, Turkey (Türkiye)

Location

Bayindir Hastanesi Sogutozu, Kulak Burun Bogaz Bas ve Boyun Cerrahisi Bolumu

Ankara, 06530, Turkey (Türkiye)

Location

Uludag Universitesi Saglik Uygulama ve Arastirma Merkezi, Kulak Burum Bogaz Hastaliklari Ana Bilim Dali

Bursa, 16059, Turkey (Türkiye)

Location

Istanbul Universitesi Istanbul Tip Fakultesi Kulak Burun Bogaz Hastaliklari Anabilim Dali

Istanbul, 34093, Turkey (Türkiye)

Location

Acibadem Maslak Hastanesi Kulak Burun Bogaz Bolumu

Istanbul, 34457, Turkey (Türkiye)

Location

Ege Universitesi Tip Fakultesi Kulak Burun Bogaz Hastaliklari Anabilim Dali

Izmir, 35100, Turkey (Türkiye)

Location

Dokuz Eylul Universitesi Tip Fakultesi Tip Bilimleri Bolumu Kulak Burun Bogaz Anabilim Dali

Izmir, 35340, Turkey (Türkiye)

Location

Ninewells Hospital and Medical School

Dundee, Angus, DD19SY, United Kingdom

Location

Royal Victoria Hospital

Belfast, BT126BA, United Kingdom

Location

Cambridge University Hospitals NHS Foundation Trust

Cambridge, CB20QQ, United Kingdom

Location

University Hospital of Wales

Cardiff, CF144XW, United Kingdom

Location

Gloucestershire Royal Hospital

Gloucester, GL13NN, United Kingdom

Location

University Hospitals of Leicester NHS Trust, Leicester Royal Infirmary

Leicester, LE15WW, United Kingdom

Location

Guy's and St Thomas' NHS Foundation Trust

London, SE19RT, United Kingdom

Location

Manchester Head and Neck Centre, Peter Mount Building

Manchester, M139WL, United Kingdom

Location

Norfolk & Norwich University Hospital

Norwich, NR47UY, United Kingdom

Location

The Royal Hallamshire Hospital

Sheffield, S102JF, United Kingdom

Location

Related Publications (1)

• Phillips J, Mikulec AA, Robinson JM, Skarinsky D, Anderson JJ. Efficacy of Intratympanic OTO-104 for the Treatment of Meniere's Disease: The Outcome of Three Randomized, Double-Blind, Placebo-Controlled Studies. Otol Neurotol. 2023 Jul 1;44(6):584-592. doi: 10.1097/MAO.0000000000003886. Epub 2023 Apr 22.

  PMID: 37185596 DERIVED

MeSH Terms

Conditions

Meniere Disease; Vertigo; Endolymphatic Hydrops; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases

Condition Hierarchy (Ancestors)

Vestibular Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Otonomy Medical Information Center
• Organization: Otonomy, Inc.

medinfo@otonomy.com

1-844-686-4636

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Double-blind, Placebo-controlled, Multicenter

Study Record Dates

• First Submitted: August 31, 2018
• First Posted: September 10, 2018
• Study Start: August 27, 2018
• Primary Completion: December 22, 2020
• Study Completion: December 22, 2020
• Last Updated: December 7, 2022
• Results First Posted: December 7, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (11); GB (10); PL (7); BE (4); IT (4); ES (4); TU (8); US (17)