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

Phase 3

Completed

Conditions: Meniere Disease

Interventions: Drug: OTO-104
Drug: Placebo

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

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.

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): Central California Clinical Research
🇺🇸
Fresno, California, United States
University of Colorado School of Medicine
🇺🇸
Aurora, Colorado, United States
Colorado ENT & Allergy
🇺🇸
Colorado Springs, Colorado, United States
Yale University School of Medicine
🇺🇸
New Haven, Connecticut, United States
Ear, Nose and Throat Associates of South Florida
🇺🇸
Boynton Beach, Florida, United States
Ear Research Foundation
🇺🇸
Sarasota, Florida, United States
Tandem Clinical Research
🇺🇸
Marrero, Louisiana, United States
Michigan Ear Institute
🇺🇸
Farmington Hills, Michigan, United States
Saint Louis University
🇺🇸
Saint Louis, Missouri, United States
Dent Neurologic Institute
🇺🇸
Amherst, New York, United States
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Central California Clinical Research
🇺🇸Fresno, California, United States