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

Primary Purpose

Meniere's Disease

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
endolymphatic sac drainage with steroids
Sponsored by
Osaka University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Meniere's Disease focused on measuring Meniere's disease, inner ear, endolymphatic sac drainage, steroids, declined surgery, natural course, Efficacy of steroids via endolymphatic sac, for intractable Meniere's disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Otolaryngology, Osaka University, School of Medicine

Outcomes

Primary Outcome Measures

the ratio of patients in vertigo supression and hearing improvement

Secondary Outcome Measures

the ratio of patients in canal improvement

Full Information

First Posted
July 11, 2007
Last Updated
July 23, 2007
Sponsor
Osaka University
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1. Study Identification

Unique Protocol Identification Number
NCT00500474
Brief Title
Effects of Endolymphatic Sac Drainage With Steroids for Meniere's Disease
Acronym
EDSS
Official Title
Clinical Study of Endolymphatic Sac Drainage With or Without Steroids for Intractable Meniere's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2007
Overall Recruitment Status
Completed
Study Start Date
April 1996 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Osaka University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meniere's Disease
Keywords
Meniere's disease, inner ear, endolymphatic sac drainage, steroids, declined surgery, natural course, Efficacy of steroids via endolymphatic sac, for intractable Meniere's disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
197 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
endolymphatic sac drainage with steroids
Primary Outcome Measure Information:
Title
the ratio of patients in vertigo supression and hearing improvement
Time Frame
post-operative 2-7 years
Secondary Outcome Measure Information:
Title
the ratio of patients in canal improvement
Time Frame
post-operative 2 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tadashi Kitahara, M.D.,Ph.D.
Organizational Affiliation
Department of Otolaryngology, Osaka University, School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Otolaryngology, Osaka University, School of Medicine
City
Suita-city
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
14669532
Citation
Kitahara T, Fukushima M, Uno Y, Mishiro Y, Kubo T. Up-regulation of cochlear aquaporin-3 mRNA expression after intra-endolymphatic sac application of dexamethasone. Neurol Res. 2003 Dec;25(8):865-70. doi: 10.1179/016164103771953989.
Results Reference
background
PubMed Identifier
24979126
Citation
Kitahara T, Horii A, Imai T, Ohta Y, Morihana T, Inohara H, Sakagami M. Effects of endolymphatic sac decompression surgery on vertigo and hearing in patients with bilateral Meniere's disease. Otol Neurotol. 2014 Dec;35(10):1852-7. doi: 10.1097/MAO.0000000000000469.
Results Reference
derived

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

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