OTO-104 for Meniere's Disease
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01084525 |
Recruitment Status :
Completed
First Posted : March 10, 2010
Last Update Posted : June 8, 2011
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Meniere's Disease | Drug: OTO-104 (steroid) 3 mg Drug: Placebo Drug: OTO-104 (steroid) 12 mg | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 44 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 1B Study of OTO-104 Given as a Single Intratympanic Injection in Subjects With Unilateral Meniere's Disease |
Study Start Date : | March 2010 |
Actual Primary Completion Date : | March 2011 |
Actual Study Completion Date : | April 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: OTO-104 (steroid) 3 mg |
Drug: OTO-104 (steroid) 3 mg
OTO-104 3 mg dose cohort, single intratympanic injection. |
Placebo Comparator: Placebo |
Drug: Placebo
Placebo arm will be conducted in parallel with each OTO-104 dose cohort. |
Experimental: OTO-104 (steroid) 12 mg
The start of 12 mg dose cohort is contingent on safety data from 3 mg dose cohort.
|
Drug: OTO-104 (steroid) 12 mg
Sequential dose cohort escalation to OTO-104 12 mg dose cohort will occur pending the safety evaluation of 28 day follow up safety data for the OTO-104 3 mg dose cohort. OTO-104 12mg dose cohort is also a single intratympanic injection. |
- The primary objective of this study is to evaluate the safety and tolerability of two ascending OTO-104 doses relative to placebo. Safety assessments will be performed for 3 months post single intratympanic injection of OTO-104 or placebo. [ Time Frame: 3 months ]
- The secondary objective of this study is to evaluate the clinical activity of two OTO-104 doses relative to placebo. Change in baseline for vertigo frequency will be evaluated with descriptive statistics. [ Time Frame: 3 months ]
- The impact of tinnitus on activities of daily living will be measured. [ Time Frame: 3 months ]
- Hearing loss in the affected ear will be measured by audiometric examination. [ Time Frame: 3 months ]
- Quality of life will be measured by patient reported questionnaire. [ Time Frame: 3 months ]
- Severity of vertigo episodes will be measured by the patient reported vertigo score. [ Time Frame: 3 months ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
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 asymmetric low frequency sensorineural hearing loss.
- Subject agrees to maintain their current treatments for Meniere's disease while on-study.
- Subjects not currently on a low-salt diet or diuretic should have a medical history of having used one or both of these treatments for at least 1 month without relief of symptoms.
- 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 has an infection in the ear, sinuses, or upper respiratory system.
- 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 had a duration of Meniere's disease of >20 years.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01084525
United States, California | |
House Ear Institute | |
Los Angeles, California, United States, 90057 | |
University of California, San Diego | |
San Diego, California, United States, 92037-0970 | |
United States, Colorado | |
Colorado Otolaryngology Associates | |
Colorado Springs, Colorado, United States, 80909 | |
United States, Florida | |
Silverstein Institute | |
Sarasota, Florida, United States, 34239 | |
United States, Illinois | |
Northwestern University, Feinberg School of Medicine, Otolaryngology | |
Chicago, Illinois, United States, 60611 | |
United States, Massachusetts | |
Mass Eye & Ear Infirmary | |
Boston, Massachusetts, United States, 02114 | |
United States, Michigan | |
University of Michigan Hospitals, Dept. of Otolaryngology | |
Ann Arbor, Michigan, United States, 48109 | |
Michigan Ear Institute | |
Farmington Hills, Michigan, United States, 48334 | |
United States, Missouri | |
St Louis University | |
St Louis, Missouri, United States, 63110 | |
United States, New York | |
New York Eye and Ear Infirmary | |
New York, New York, United States, 10003 | |
United States, North Carolina | |
Crescent Medical Research | |
Salisbury, North Carolina, United States, 28144 | |
Wilmington Medical Research | |
Wilmington, North Carolina, United States, 28401 | |
Piedmont Medical Research | |
Winston-Salem, North Carolina, United States, 27103 | |
United States, South Carolina | |
Medical University of South Carolina | |
Charleston, South Carolina, United States, 29425 | |
United States, Texas | |
University Of Texas, Southwestern Medical Center | |
Dallas, Texas, United States, 75390 |
Study Chair: | Carl LeBel, PhD | Otonomy, Inc. |
Responsible Party: | Carl LeBel, PhD, Chief Scientific Officer, Otonomy, Inc |
ClinicalTrials.gov Identifier: | NCT01084525 |
Other Study ID Numbers: |
104-200901 |
First Posted: | March 10, 2010 Key Record Dates |
Last Update Posted: | June 8, 2011 |
Last Verified: | June 2011 |
Meniere's Disease Vertigo Definitive vertigo Vertigo episodes |
Vertigo frequency Tinnitus Hearing loss Aural Fullness |
Meniere Disease Endolymphatic Hydrops Labyrinth Diseases Ear Diseases Otorhinolaryngologic Diseases |