NCT02740387

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2016

Shorter than P25 for phase_2

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 15, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
1.3 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
Last Updated

September 15, 2017

Status Verified

September 1, 2017

Enrollment Period

1.3 years

First QC Date

March 25, 2016

Last Update Submit

September 14, 2017

Conditions

Meniere's Disease

Outcome Measures

Primary Outcomes (1)

  • Evaluation of adverse events as a measure of safety and tolerability

    Up to 1 Year

Secondary Outcomes (3)

  • 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

Study Arms (1)

OTO-104

EXPERIMENTAL

12 mg dexamethasone

Drug: OTO-104

Interventions

OTO-104DRUG
Also known as: Single intratympanic injection 12 mg OTO-104
OTO-104

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject has a diagnosis of definite unilateral Meniere's disease.
  • Subject agrees to maintain their current standard of care treatments for Meniere's disease while on-study.

You may not qualify if:

  • Subject has an infection in the ear, sinuses, or upper respiratory system.
  • Subject is pregnant or lactating.
  • Subject has a history of immunodeficiency disease.
  • Subject has active or recent (\<1 month prior to screening) middle ear disease, including but not limited to: chronic otitis media, acute otitis media, middle ear effusions, middle ear atelectasis, or cholesteatoma.
  • Subject has experienced an adverse reaction to intratympanic injection of steroids.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Call Otonomy call center for trial locations

London, Ontario, Canada

Location

MeSH Terms

Conditions

Meniere Disease

Interventions

Injection, Intratympanic

Condition Hierarchy (Ancestors)

Endolymphatic HydropsLabyrinth DiseasesEar DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

InjectionsDrug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Kathie Bishop, PhD

    Otonomy, Inc.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2016

First Posted

April 15, 2016

Study Start

June 1, 2016

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

September 15, 2017

Record last verified: 2017-09

Locations

CA(1)