Clinical trial NCT02717442: Study of OTO-104 in Subjects With Unilateral Meniere's Disease
Official title: A Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study of OTO-104 Given as a Single Intratympanic Injection in Subjects With Unilateral Meniere's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Meniere's Disease
Keywords: Meniere's Disease
Vertigo
Lead sponsor: Otonomy, Inc.
Sponsor class: INDUSTRY
First posted: 2016-03-23
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: The Number of DVD at Week 12 (the 4-week [28 Days] Interval From Week 9 Through Week 12) - FAS-1 Population
timeFrame: 3 months
measure: The Number of DVD at Week 12 (the 4-week [28 Days] Interval From Week 9 Through Week 12) - FAS-2 Population
timeFrame: 3 months
Secondary outcomes:
measure: Effect of Vertigo on Daily Activities - Number of Days Sick at Home or Bedridden at Week 12 (Month 3): FAS-1
timeFrame: 3 months
measure: Effect of Vertigo on Daily Activities - Number of Days Sick at Home or Bedridden at Week 12 (Month 3): FAS-2
timeFrame: 3 months
measure: Otoscopic Examination - Tympanic Membrane Perforation at Week 12 (Month 3)
timeFrame: 3 months
measure: Audiometry - Shift in Air-Bone Gap at 500 Hz From Baseline to Week 12 (Month 3)
timeFrame: 3 Months
measure: Audiometry - Shift in Air-Bone Gap at 1000 Hz From Baseline to Week 12 (Month 3)
timeFrame: 3 months
measure: Audiometry - Shift in Air-Bone Gap at 2000 Hz From Baseline to Week 12 (Month 3)
timeFrame: 3 months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Many sites in Europe. Refer to the contact info listed below.
state: California
Study officials:
affiliation: Otonomy, Inc.
name: Kathie Bishop, PhD
role: STUDY_CHAIR
References: