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

Phase 3TerminatedNCT02768662

Otonomy, Inc.142 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

142

Conditions

Meniere's Disease

Interventions

OTO-104DRUG

Single intratympanic injection of 12 mg OTO-104

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

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

San Diego, California, United States

Outcomes

Primary Outcomes

Otoscopic Examination - Tympanic Membrane Perforation at Week 24 (Month 6)

Otoscopic exams were conducted at each visit. It was considered important to understand if the tympanic membrane perforation that resulted from the IT injection persisted at the end of study visit (24 Weeks \[Month 6\]).

Time frame: 6 Months

Data from ClinicalTrials.gov

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