A 6-Month Extension Study of OTO-104 in Meniere's Disease

Last updated: December 28, 2022
Sponsor: Otonomy, Inc.
Overall Status: Terminated

Phase

3

Condition

Hearing Loss

Vestibular Hypofunction

Hearing Impairment

Treatment

N/A

Clinical Study ID

NCT02768662
104-201610
  • Ages > 18
  • All Genders

Study Summary

This is an open-label extension study of a single intratympanic injection of OTO-104 given every 3 months for a total of 2 injections. Subjects must have completed either Otonomy study 104-201403 (1-Year, Phase 2, Safety Study of OTO-104) or 104-201508 (Phase 3 Study of OTO-104) in order to be eligible for this open-label extension study.

Eligibility Criteria

Inclusion

Inclusion Criteria includes, but is not limited to:

  • Subject has completed the Phase 2 OTO-104 1-Year Safety Study (104-201403) or Phase 3 (104-201508) clinical study.

  • Subject has a diagnosis of definite unilateral Meniere's disease by 1995 AAO-HNS criteria

Exclusion Criteria includes, but is not limited to:

  • Subject is pregnant or lactating.

  • Subject has a history of immunodeficiency disease.

  • Subject has experienced an adverse reaction to intratympanic injection of steroids.

Study Design

Total Participants: 142
Study Start date:
August 01, 2016
Estimated Completion Date:
September 30, 2017

Connect with a study center

  • Many sites in Europe. Refer to the contact info listed below.

    San Diego, California 92121
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.