OTO-104 for the Treatment of Meniere's Disease

This study has been completed.
Information provided by (Responsible Party):
Otonomy, Inc.
ClinicalTrials.gov Identifier:
First received: July 31, 2011
Last updated: August 18, 2015
Last verified: August 2015

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

Condition Intervention Phase
Meniere's Disease
Drug: OTO-104
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 2b Study of OTO-104 Given as a Single Intratympanic Injection in Subjects With Unilateral Meniere's Disease

Resource links provided by NLM:

Further study details as provided by Otonomy, Inc.:

Primary Outcome Measures:
  • Reduction in vertigo frequency as measure of efficacy of OTO-104 in subjects with Meniere's disease [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation of adverse events, otoscopic exams, audiometry, Word Recognition Score and tympanometry as a measure of safety and tolerability [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
  • Evaluation of tinnitus patient reported questionnaire and daily diary as a measure of impact of tinnitus on activities of daily living [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Evaluation of patient reported questionnaires as a measure of impact on patient daily activities [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Enrollment: 154
Study Start Date: November 2013
Study Completion Date: April 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OTO-104 Drug: OTO-104
Single intratympanic injection of 12 mg OTO-104
Placebo Comparator: Placebo Drug: Placebo
Single intratympanic injection of placebo


Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  • Subjects currently on a low-salt diet and/or diuretic at the time of screening agree to continue this treatment throughout the study.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01412177

United States, California
Many sites in US and Canada. Refer to the contact info listed below.
San Diego, California, United States
United States, Ohio
UC Health Otolaryngology - Head and Neck Surgery
Cincinnati, Ohio, United States, 45219
Sponsors and Collaborators
Otonomy, Inc.
Study Chair: Carl LeBel, PhD Otonomy, Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Otonomy, Inc.
ClinicalTrials.gov Identifier: NCT01412177     History of Changes
Other Study ID Numbers: 104-201102
Study First Received: July 31, 2011
Last Updated: August 18, 2015
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Otonomy, Inc.:
Meniere's Disease
Definitive vertigo
Vertigo episodes
Vertigo frequency
Hearing loss
Aural fullness

Additional relevant MeSH terms:
Meniere Disease
Ear Diseases
Endolymphatic Hydrops
Labyrinth Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on October 06, 2015