Effects of Endolymphatic Sac Drainage With Steroids for Meniere's Disease (EDSS)

July 23, 2007 updated by: Osaka University

Clinical Study of Endolymphatic Sac Drainage With or Without Steroids for Intractable Meniere's Disease

Meniere's disease is a common inner ear disease with an incidence of 15-50 per 100,000 population. Since Meniere's disease is thought to be triggered by an immune insult to inner ear, we examined intra-endolymphatic sac application of large doses of steroids as de novo treatment for intractable Meniere's disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Meniere's disease characterized by recurrent attacks of vertigo, fluctuating hearing loss and tinnitus, is a common disease with an incidence of 15-50 per 100,000 population. Some patients with Meniere's disease are strongly prevented from participating in activities of daily life and interaction with their social environment, such as work and schooling, due to frequent attacks of vertigo especially with progressive sensorineural hearing loss, in spite of various kinds of medication. This type of Meniere's disease is called intractable Meniere's disease. Although the oto-pathology in Meniere's temporal bones was revealed in 1938 to be inner ear endolymphatic hydrops, the definitive pathogenesis of Meniere's disease is still unknown and there is no radical treatment for this disease.

It has, however, been reported that Meniere's disease is usually triggered by immune, metabolic, infectious, traumatic or other insults to the inner ear, associated with a small misplaced malfunctioning endolymphatic sac. Among these insults, immune-mediated responses in the inner ear endo-organs such as the endolymphatic sac, stria vascularis and spiral ligament, are thought to be the main reason for the development of symptoms in Meniere's disease. Thus, systemic administration and/or local perfusion of corticosteroids into the middle ear have been adopted as an anti-immune or anti-inflammatory therapy for patients with intractable Meniere's disease. These treatments were reported to result in good relief from vertigo and improvement of hearing in some cases. However, these results especially for hearing did not last long enough to discontinue additional repetitive applications of steroids. Since Meniere's disease is characterized by repeated attacks of vertigo with fluctuating and/or progressive hearing loss unlike other inner ear diseases without recurrence such as sudden deafness and vestibular neuritis, it is necessary to refrain from repetitive applications of steroids for the long-term follow-up with Meniere's patients because of side effects.

For inner ear drug delivery, we noted another hopeful but unevaluated route, the longitudinal route from the endolymphatic sac to the cochlea and vestibule, suggested by several lines of evidence in animal studies. Morgenstern et al. and Lee et al. demonstrated that the intra-endolymphatic sac materials could reach the cochlear endolymphatic site through the vestibular aqueduct using a test marker and an oto-toxic drug, respectively. Recently, Yamasoba et al. suggested the possibility of gene therapy through the vestibular aqueduct route. We also revealed that intra-endolymphatic sac steroids could up-regulate a water channel molecule, aquaporin-3 mRNA in the cochlea.

In the present study, we examined the intra-endolymphatic sac application of large doses of steroids as de novo treatment for intractable Meniere's disease.

Study Type

Interventional

Enrollment (Actual)

197

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Osaka
      • Suita-city, Osaka, Japan, 565-0871
        • Department of Otolaryngology, Osaka University, School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of Meniere's Disease, who did not respond to various forms of medical and psychological managements for at least 6 months, i.e. intractable Meniere's disease.

Exclusion Criteria:

  • Other known causes of vertigo including central lesion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the ratio of patients in vertigo supression and hearing improvement
Time Frame: post-operative 2-7 years
post-operative 2-7 years

Secondary Outcome Measures

Outcome Measure
Time Frame
the ratio of patients in canal improvement
Time Frame: post-operative 2 years
post-operative 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Osaka University

Investigators

  • Principal Investigator: Tadashi Kitahara, M.D.,Ph.D., Department of Otolaryngology, Osaka University, School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 1996

Study Completion (Actual)

March 1, 2005

Study Registration Dates

First Submitted

July 11, 2007

First Submitted That Met QC Criteria

July 11, 2007

First Posted (Estimate)

July 12, 2007

Study Record Updates

Last Update Posted (Estimate)

July 25, 2007

Last Update Submitted That Met QC Criteria

July 23, 2007

Last Verified

July 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • tk19661217
  • tk20090401

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Meniere's Disease

Clinical Trials on endolymphatic sac drainage with steroids

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Venezuela

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe