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

Vomiting

Hearing Loss

Vestibular Hypofunction

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

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