NCT02768662

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
142

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2016

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 11, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
5.4 years until next milestone

Results Posted

Study results publicly available

January 20, 2023

Completed
Last Updated

January 20, 2023

Status Verified

December 1, 2022

Enrollment Period

1.1 years

First QC Date

May 9, 2016

Results QC Date

October 20, 2022

Last Update Submit

December 28, 2022

Conditions

Meniere's Disease

Outcome Measures

Primary Outcomes (1)

  • 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 \[Month 6\]).

    6 Months

Study Arms (1)

OTO-104

EXPERIMENTAL

12 mg dexamethasone

Drug: OTO-104

Interventions

OTO-104DRUG

Single intratympanic injection of 12 mg OTO-104

OTO-104

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Subject is pregnant or lactating.
  • Subject has a history of immunodeficiency disease.
  • Subject has experienced an adverse reaction to intratympanic injection of steroids.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

San Diego, California, 92121, United States

Location

MeSH Terms

Conditions

Meniere Disease

Condition Hierarchy (Ancestors)

Endolymphatic HydropsLabyrinth DiseasesEar DiseasesOtorhinolaryngologic Diseases

Results Point of Contact

Title
Otonomy Medical information Center
Organization
Otonomy, Inc.
medinfo@otonomy.com
1-844-686-4636

Study Officials

  • Kathie Bishop, PhD

    Otonomy, Inc.

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2016

First Posted

May 11, 2016

Study Start

August 1, 2016

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

January 20, 2023

Results First Posted

January 20, 2023

Record last verified: 2022-12

Locations

US(1)