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Study of OTO-104 in Subjects With Unilateral Meniere's Disease (AVERTS-1)

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ClinicalTrials.gov Identifier: NCT02612337
Recruitment Status : Completed
First Posted : November 23, 2015
Last Update Posted : August 21, 2017
Sponsor:
Information provided by (Responsible Party):
Otonomy, Inc.

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

Condition or disease Intervention/treatment Phase
Meniere's Disease Drug: OTO-104 Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 165 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 3 Study of OTO-104 Given as a Single Intratympanic Injection in Subjects With Unilateral Meniere's Disease
Actual Study Start Date : October 2015
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: OTO-104
12 mg dexamethasone
Drug: OTO-104
Single intratympanic injection of 12 mg OTO-104

Placebo Comparator: Placebo Drug: Placebo
Single intratympanic injection of placebo




Primary Outcome Measures :
  1. Reduction in number of definitive vertigo days compared to placebo [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Audiometry [ Time Frame: 3 months ]
  2. Otoscopic examinations [ Time Frame: 3 months ]
  3. Evaluation of adverse events as a measure of safety and tolerability [ Time Frame: 3 months ]
  4. Impact of vertigo experience on daily activities [ Time Frame: 3 months ]
    Questionnaire



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria includes, but is not limited to:

  • 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.

Exclusion Criteria includes, but is not limited to:

  • 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.

Information from the National Library of Medicine

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): NCT02612337


Locations
United States, California
Many sites in US. Refer to the contact info listed below.
San Diego, California, United States
Sponsors and Collaborators
Otonomy, Inc.
Investigators
Study Chair: Kathie Bishop, PhD Otonomy, Inc.

Responsible Party: Otonomy, Inc.
ClinicalTrials.gov Identifier: NCT02612337     History of Changes
Other Study ID Numbers: 104-201506
First Posted: November 23, 2015    Key Record Dates
Last Update Posted: August 21, 2017
Last Verified: August 2017

Keywords provided by Otonomy, Inc.:
Meniere's Disease
Vertigo

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