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

Meniere Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03664674
• Other study ID #: 104-201811
• Status: Completed
• Phase: Phase 3
• Start date: August 27, 2018
• Est. completion date: December 22, 2020

Study information

• Verified date: November 2022
• Source: Otonomy, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: December 22, 2020
• Est. primary completion date: December 22, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Meniere Disease

Intervention

Drug:
• OTO-104
Single intratympanic injection of 12 mg dexamethasone
• Placebo
Single intratympanic injection of placebo

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Antwerpen - Ear-Nose-Throat Department	Edegem
Belgium	UZ Gent - Ear-Nose-Throat Department	Gent
Belgium	UZ Leuven - Ear-Nose-Throat Department	Leuven
Belgium	CHU de Liège - Ear-Nose-Throat Department	Liège
Germany	Uniklinik RWTH Aachen, Klinik für Hals-, Nasen-, Ohrenheilkunde und Plastische Kopf- und Halschirurgie	Aachen
Germany	Praxis Bad Essen	Bad Essen
Germany	Charité Universitätsmedizin Berlin	Berlin
Germany	HNO Zentrum am Kudamm	Berlin
Germany	HNO-Praxis Göttingen	Göttingen
Germany	HNO Praxis am Neckar	Heidelberg
Germany	HNO Praxis Dres. med. Florian Heimlich und Angelika Witzel-Heimlich	Heidelberg
Germany	Universitätsklinikum Mannheim	Mannheim
Germany	HNO Praxis Dr. med. Roger Fisher	Markkleeberg
Germany	Klinikum der Universität München	München
Germany	Universitätsklinikum Ulm, HNO-Klinik. Kopf-Hals-Chirurgie	Ulm
Italy	U.O. di Otorinolaringoiatria Universitaria	Bari	NAP
Italy	Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico - U.O.S.D. Audiologia	Milano
Italy	Unità Operativa di Otorinolaringoiatria	Piacenza
Italy	Azienda Ospedaliera-Universitaria Sant' Andrea; Dipartimento Organi di Senso-U.O.C. Otorinolaringoiatria	Roma
Poland	10 Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ Oddzial	Bydgoszcz
Poland	Centrum Medyczne PROMED	Kraków
Poland	Centrum Medyczne ZDROWA	Kraków
Poland	MT Medic Specjalistyczna Praktyka Lekarska Tomasz Stapinski	Krosno
Poland	ETG Lódz	Lódz
Poland	Centrum Sluchu i Mowy Sp. z o.o.	Nadarzyn
Poland	Kliniczny Szpital Wojewódzki Nr 1 im. Fryderyka Chopina	Rzeszów
Spain	Agencia Pública Empresarial Sanitaria Hospital de Poniente	El Ejido	Almería
Spain	Hospital Universitario de Getafe	Getafe	Madrid
Spain	Hospital Universitario Virgen de las Nieves	Granada
Spain	Hospital Universitario Virgen Macarena	Sevilla
Turkey	Baskent Universitesi Ankara Hastanesi, Kulak Burun Bogaz Hastaliklari Ana Bilim Dali	Ankara
Turkey	Bayindir Hastanesi Sogutozu, Kulak Burun Bogaz Bas ve Boyun Cerrahisi Bolumu	Ankara
Turkey	Hacettepe Universitesi Tip Fakultesi Kulak Burun Bogaz Hastaliklari Anabilim Dali	Ankara
Turkey	Uludag Universitesi Saglik Uygulama ve Arastirma Merkezi, Kulak Burum Bogaz Hastaliklari Ana Bilim Dali	Bursa
Turkey	Acibadem Maslak Hastanesi Kulak Burun Bogaz Bolumu	Istanbul
Turkey	Istanbul Universitesi Istanbul Tip Fakultesi Kulak Burun Bogaz Hastaliklari Anabilim Dali	Istanbul
Turkey	Dokuz Eylul Universitesi Tip Fakultesi Tip Bilimleri Bolumu Kulak Burun Bogaz Anabilim Dali	Izmir
Turkey	Ege Universitesi Tip Fakultesi Kulak Burun Bogaz Hastaliklari Anabilim Dali	Izmir
United Kingdom	Royal Victoria Hospital	Belfast
United Kingdom	Cambridge University Hospitals NHS Foundation Trust	Cambridge
United Kingdom	University Hospital of Wales	Cardiff
United Kingdom	Ninewells Hospital and Medical School	Dundee	Angus
United Kingdom	Gloucestershire Royal Hospital	Gloucester
United Kingdom	University Hospitals of Leicester NHS Trust, Leicester Royal Infirmary	Leicester
United Kingdom	Guy's and St Thomas' NHS Foundation Trust	London
United Kingdom	Manchester Head and Neck Centre, Peter Mount Building	Manchester
United Kingdom	Norfolk & Norwich University Hospital	Norwich
United Kingdom	The Royal Hallamshire Hospital	Sheffield
United States	Dent Neurologic Institute	Amherst	New York
United States	University of Colorado School of Medicine	Aurora	Colorado
United States	Ear, Nose and Throat Associates of South Florida	Boynton Beach	Florida
United States	Medical University of South Carolina, Department of Otolaryngology	Charleston	South Carolina
United States	Colorado ENT & Allergy	Colorado Springs	Colorado
United States	Intermountain Ear, Nose & Throat Specialists	Draper	Utah
United States	Michigan Ear Institute	Farmington Hills	Michigan
United States	Central California Clinical Research	Fresno	California
United States	Tandem Clinical Research	Marrero	Louisiana
United States	Charlotte Eye Ear Nose & Throat Associates, P.A.	Matthews	North Carolina
United States	West Virginia University School of Medicine	Morgantown	West Virginia
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Yale University School of Medicine	New Haven	Connecticut
United States	New York Eye and Ear Infirmary of Mount Sinai	New York	New York
United States	Saint Louis University	Saint Louis	Missouri
United States	Ear Research Foundation	Sarasota	Florida
United States	Piedmont Ear, Nose, and Throat Associates, PA	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Otonomy, Inc.

Countries where clinical trial is conducted

United States,  Belgium,  Germany,  Italy,  Poland,  Spain,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)