OTO-104 for Meniere's Disease

This study has been completed.
Sponsor:
Information provided by:
Otonomy, Inc.
ClinicalTrials.gov Identifier:
NCT01084525
First received: March 8, 2010
Last updated: June 7, 2011
Last verified: June 2011

March 8, 2010
June 7, 2011
March 2010
March 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01084525 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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: Yes ]
  • The impact of tinnitus on activities of daily living will be measured. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Hearing loss in the affected ear will be measured by audiometric examination. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • 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: Yes ]
Not Provided
Not Provided
 
OTO-104 for Meniere's Disease
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

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Meniere's Disease
  • Drug: OTO-104 (steroid) 3 mg
    OTO-104 3 mg dose cohort, single intratympanic injection.
  • Drug: Placebo
    Placebo arm will be conducted in parallel with each OTO-104 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.
  • Experimental: OTO-104 (steroid) 3 mg
    Intervention: Drug: OTO-104 (steroid) 3 mg
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: OTO-104 (steroid) 12 mg
    The start of 12 mg dose cohort is contingent on safety data from 3 mg dose cohort.
    Intervention: Drug: OTO-104 (steroid) 12 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
April 2011
March 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. 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.
  2. Subject has experienced active vertigo during the lead-in period.
  3. Subject has asymmetric low frequency sensorineural hearing loss.
  4. Subject agrees to maintain their current treatments for Meniere's disease while on-study.
  5. 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.
  6. 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:

  1. Subject has an infection in the ear, sinuses, or upper respiratory system.
  2. Subject is pregnant or lactating.
  3. Subject has a history of immunodeficiency disease.
  4. Subject has a history of previous endolymphatic sac surgery.
  5. Subject has a history of previous use of intratympanic (IT) gentamicin in the affected ear.
  6. Subject has a history of tympanostomy tubes with evidence of perforation or lack of closure.
  7. Subject has experienced an adverse reaction to IT injection of steroids.
  8. Subject has used an investigational drug or device in the 3 months prior to screening.
  9. Subject has had a duration of Meniere's disease of >20 years.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01084525
104-200901
Yes
Carl LeBel, PhD, Chief Scientific Officer, Otonomy, Inc
Otonomy, Inc.
Not Provided
Study Chair: Carl LeBel, PhD Otonomy, Inc.
Otonomy, Inc.
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP