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

Phase 3

Terminated

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

• Registration Number: NCT02768662
• Lead Sponsor: Otonomy, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-09
• Study First Submitted QC: 2016-05-09
• Study First Posted: 2016-05-11
• Study Start: 2016-08
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Results First Submitted: 2022-10-20
• Status Verified: 2022-12
• Results First Submitted QC: 2022-12-28
• Last Update Submitted: 2022-12-28
• Results First Posted: 2023-01-20
• Last Update Posted: 2023-01-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 142

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
Otoscopic Examination - Tympanic Membrane Perforation at Week 24 (Month 6)	6 Months	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 \[Month 6\]).

Trial Locations

Locations (1)

Many sites in Europe. Refer to the contact info listed below.; 🇺🇸 San Diego, California, United States