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

Meniere's Disease Clinical Trial

— EDSS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00500474
• Other study ID #: tk19661217
• Secondary ID: tk20090401
• Status: Completed
• Phase: N/A
• First received: July 11, 2007
• Last updated: July 23, 2007
• Start date: April 1996
• Est. completion date: March 2005

Study information

• Verified date: July 2007
• Source: Osaka University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Meniere Disease
• Meniere's Disease

Intervention

Procedure:
• endolymphatic sac drainage with steroids

Locations

Country	Name	City	State
Japan	Department of Otolaryngology, Osaka University, School of Medicine	Suita-city	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Osaka University

Country where clinical trial is conducted

Japan, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the ratio of patients in vertigo supression and hearing improvement		post-operative 2-7 years
Secondary	the ratio of patients in canal improvement		post-operative 2 years