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

• Sponsor: Otonomy, Inc. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT02768662
• Collaborator: (none)
• Enrollment: 141
• Location: 1
• Arm: 1
• Actual Duration (Months): 13
• Patients Per Site Per Month: 10.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Meniere's Disease	Drug: OTO-104	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 141 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A 6-Month, Multicenter, Phase 3, Open-Label Extension Safety Study of OTO-104 Given At 3-Month Intervals by Intratympanic Injection in Subjects With Unilateral Meniere's Disease
• Actual Study Start Date: Aug 1, 2016
• Actual Primary Completion Date: Sep 1, 2017
• Actual Study Completion Date: Sep 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: OTO-104 12 mg dexamethasone	Drug: OTO-104; Single intratympanic injection of 12 mg OTO-104

Outcome Measures

Primary Outcome Measures

1. Safety as assessed by adverse events [6 Months]

   Evaluation of adverse events

2. Safety as assessed by otoscopic exams [6 Months]

   Evaluation of otoscopic exams

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Many sites in Europe. Refer to the contact info listed below.	San Diego	California	United States	92121

Sponsors and Collaborators

• Otonomy, Inc.

Investigators

• Study Chair: Kathie Bishop, PhD, Otonomy, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Otonomy, Inc.
• ClinicalTrials.gov Identifier: NCT02768662
• Other Study ID Numbers: 104-201610
• First Posted: May 11, 2016
• Last Update Posted: Sep 15, 2017
• Last Verified: Sep 1, 2017

• Additional relevant MeSH terms: Meniere Disease

Study Results

No Results Posted as of Sep 15, 2017