NCT01412177

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
154

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2013

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 9, 2011

Completed
2.2 years until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

September 3, 2015

Status Verified

August 1, 2015

Enrollment Period

1.3 years

First QC Date

July 31, 2011

Last Update Submit

August 18, 2015

Conditions

Meniere's Disease

Keywords

Meniere's DiseaseVertigoDefinitive vertigoVertigo episodesVertigo frequencyTinnitusHearing lossAural fullness

Outcome Measures

Primary Outcomes (1)

  • Reduction in vertigo frequency as measure of efficacy of OTO-104 in subjects with Meniere's disease

    4 months

Secondary Outcomes (3)

  • Evaluation of adverse events, otoscopic exams, audiometry, Word Recognition Score and tympanometry as a measure of safety and tolerability

    4 months

  • Evaluation of tinnitus patient reported questionnaire and daily diary as a measure of impact of tinnitus on activities of daily living

    4 months

  • Evaluation of patient reported questionnaires as a measure of impact on patient daily activities

    4 months

Study Arms (2)

OTO-104

EXPERIMENTAL
Drug: OTO-104

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

OTO-104DRUG

Single intratympanic injection of 12 mg OTO-104

OTO-104
PlaceboDRUG

Single intratympanic injection of placebo

Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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.
  • Subjects currently on a low-salt diet and/or diuretic at the time of screening agree to continue this treatment throughout the study.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

San Diego, California, United States

Location

UC Health Otolaryngology - Head and Neck Surgery

Cincinnati, Ohio, 45219, United States

Location

Related Links

MeSH Terms

Conditions

Meniere DiseaseVertigoTinnitusHearing Loss

Condition Hierarchy (Ancestors)

Endolymphatic HydropsLabyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesVestibular DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsHearing DisordersSensation Disorders

Study Officials

  • Carl LeBel, PhD

    Otonomy, Inc.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2011

First Posted

August 9, 2011

Study Start

November 1, 2013

Primary Completion

March 1, 2015

Study Completion

April 1, 2015

Last Updated

September 3, 2015

Record last verified: 2015-08

Locations

US(2)