OTO-104 for Meniere's Disease
This study has been completed.
Sponsor:
Otonomy, Inc.
Information provided by:
Otonomy, Inc.
ClinicalTrials.gov Identifier:
NCT01084525
First received: March 8, 2010
Last updated: June 7, 2011
Last verified: June 2011
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Purpose
The purpose of this study is to evaluate the safety of OTO-104 in subjects with unilateral Meniere's disease. The effectiveness of OTO-104 to reduce the symptoms of Meniere's disease will also be evaluated.
| Condition | Intervention | Phase |
|---|---|---|
|
Meniere's Disease |
Drug: OTO-104 (steroid) 3 mg Drug: Placebo Drug: OTO-104 (steroid) 12 mg |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety 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 1B 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:
- 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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- The impact of tinnitus on activities of daily living will be measured. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Hearing loss in the affected ear will be measured by audiometric examination. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Quality of life will be measured by patient reported questionnaire. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Severity of vertigo episodes will be measured by the patient reported vertigo score. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
| Enrollment: | 44 |
| Study Start Date: | March 2010 |
| Study Completion Date: | April 2011 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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.
|
Detailed Description:
Meniere's disease is a debilitating disorder of the inner ear which includes symptoms such as vertigo, tinnitus, hearing loss and aural fullness. Meniere's disease may result from an imbalance of fluid in the inner ear. Several studies have shown that corticosteroids may help manage this imbalance yet the effect does not last very long. OTO-104 is a longer lasting corticosteroid which could provide significant benefit to patients with Meniere's disease.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01084525
Locations
| 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 | |
Sponsors and Collaborators
Otonomy, Inc.
Investigators
| Study Chair: | Carl LeBel, PhD | Otonomy, Inc. |
More Information
No publications provided
| Responsible Party: | Carl LeBel, PhD, Chief Scientific Officer, Otonomy, Inc |
| ClinicalTrials.gov Identifier: | NCT01084525 History of Changes |
| Other Study ID Numbers: | 104-200901 |
| Study First Received: | March 8, 2010 |
| Last Updated: | June 7, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Otonomy, Inc.:
|
Meniere's Disease Vertigo Definitive vertigo Vertigo episodes |
Vertigo frequency Tinnitus Hearing loss Aural Fullness |
Additional relevant MeSH terms:
|
Meniere Disease Endolymphatic Hydrops Labyrinth Diseases Ear Diseases Otorhinolaryngologic Diseases |
ClinicalTrials.gov processed this record on June 18, 2013