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

Phase 3CompletedNCT02612337

Otonomy, Inc.166 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

166

Conditions

Meniere's Disease

Interventions

OTO-104DRUG

Single intratympanic injection of 12 mg OTO-104

PlaceboDRUG

Single intratympanic injection of placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria includes, but is not limited to: * 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 includes, but is not limited to: * Subject is pregnant or lactating. * Subject has a history of immunodeficiency disease. * Subject has a history of previous endolymphatic sac surgery. * Subject has a history of previous use of intratympanic (IT) gentamicin in the affected ear. * Subject has a history of tympanostomy tubes with evidence of perforation or lack of closure. * Subject has experienced an adverse reaction to IT injection of steroids. * Subject has used an investigational drug or device in the 3 months prior to screening. * Subject has previously been randomized to a trial of OTO-104.

Locations (1)

Many sites in US. Refer to the contact info listed below.

San Diego, California, United States

Outcomes

Primary Outcomes

The Number of DVD at Week 12 (Defined as the 4-week [28 Days] Interval From Week 9 Through Week 12).

The number of DVDs at Week 12 (defined as the 4-week \[28 days\] interval from Week 9 through Week 12) was compared between OTO-104 and placebo. Week 12 = 12 weeks after dosing at the Baseline visit. Baseline occurred at the end of lead-in and no intervention was administered during lead-in.

Time frame: Week 12 (3 months)

Secondary Outcomes

Effect of Vertigo on Daily Activities - Number of Days Sick at Home or Bedridden at Week 12 (Month 3)

Questionnaire - subjects were instructed to record the effect on their daily activities of their total vertigo experienced that day using a 5-point scoring system: 0 = normal activity 1. = slight limitation 2. = moderate limitation 3. = sick at home 4. = bed ridden

Time frame: 3 months

Otoscopic Examination - Tympanic Membrane Perforation at Week 12 (Month 3)

Otoscopic examinations were conducted at each visit. It was considered important to understand if the tympanic perforation that resulted from the IT injection at the Baseline visit persisted at the end of study visit (Week 12 \[Month 3\]).

Time frame: 3 months

Audiometry - Shift in Air-Bone Gap at 500 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 500 Hz.

Time frame: 3 months

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.

Time frame: Week 12 (Month 3)

Data from ClinicalTrials.gov

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