Open Label Study of OTO-104 in Subjects With Meniere's Disease

Phase 2

Terminated

• Conditions: Meniere's Disease
• Interventions: Drug: OTO-104

• Registration Number: NCT02740387
• Lead Sponsor: Otonomy, Inc.

Brief Summary

This is a 1-year, multicenter, Phase 2, open-label safety study in subjects with unilateral Meniere's disease. Subjects will receive 1 intratympanic (IT) injection of 12 mg OTO-104 at 3-month intervals for a total of 4 injections total.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-25
• Study First Submitted QC: 2016-04-11
• Study First Posted: 2016-04-15
• Study Start: 2016-06
• Status Verified: 2017-09
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Last Update Submitted: 2017-09-14
• Last Update Posted: 2017-09-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OTO-104	OTO-104	12 mg dexamethasone

Primary Outcome Measures

Name	Time	Method
Evaluation of adverse events as a measure of safety and tolerability	Up to 1 Year

Secondary Outcome Measures

Name	Time	Method
Change in hearing from baseline as assessed by audiometry	Up to 1 Year
Changes in patient condition assessed by otoscopy	Up to 1 Year
Changes in patient condition assessed by tympanometry	Up to 1 Year

Trial Locations

Locations (1)

Call Otonomy call center for trial locations; 🇨🇦 London, Ontario, Canada