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

Otonomy logo

Otonomy

Status and phase

Terminated
Phase 3

Conditions

Meniere's Disease

Treatments

Drug: OTO-104

Study type

Interventional

Funder types

Industry

Identifiers

NCT02768662
104-201610

Details and patient eligibility

About

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.

Enrollment

142 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

142 participants in 1 patient group

OTO-104
Experimental group
Description:
12 mg dexamethasone
Treatment:
Drug: OTO-104

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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