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TERMINATEDPHASE4

Evaluation of Inner Ear and Brain Structures With Contrast-enhanced MRI in Patients With Meniere's Disease

NCT02530931•University Hospital, Grenoble

Summary

* This prospective study aims to better characterize inner ear's perilymphatic structures with Magnetic Resonance Imaging using contrast media and delayed injection in patient's with Meniere's disease. * MR Perfusion Imaging will be assess in both cochlea as well * Primary auditory brain pathways will be evaluated through MR diffusion imaging

Eligibility

Age

40 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Major subjects of over 40 years (mean age of Meniere's disease 40 to 50 years)
•Informed consent signed
•Medical examination performed prior to participation in research
•Patients with clinical criteria of Meniere's disease according to the classification of the American Association of Otology (ie the combination of a sensorineural hearing loss at low frequencies, recurrent vertigo and tinnitus and / or clogged ear sensation)
•Recipient of a French social security scheme

Exclusion Criteria

•Patients minors
•Patients on a legal protection regime type guardianship
•Respiratory pathologies, cardiovascular, renal, diabetes
•Claustrophobia
•Contraindications to exposure to a magnetic field
•Contraindications to injecting Dotarem ®

Locations (1)

GrenobleUniversityHospital

Grenoble, France

Key Dates

Start Date

March 16, 2016

Primary Completion Date

September 1, 2020

Completion Date

September 1, 2020

Last Updated

November 18, 2020

Enrollment

ACTUAL participants

Conditions

Meniere's Disease

Interventions

Gadolinium

DRUG

SPI-1005 for the Treatment of Meniere's Disease (Open Label)

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Meniere's DiseaseMénière's Disease

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A 6-Month Extension Study of OTO-104 in Meniere's Disease

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Meniere's Disease

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TERMINATEDPHASE2

Open Label Study of OTO-104 in Subjects With Meniere's Disease

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 18, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Evaluation of Inner Ear and Brain Structures With Contrast-enhanced MRI in Patients With Meniere's Disease

Inclusion Criteria

Exclusion Criteria

SPI-1005 for the Treatment of Meniere's Disease (Open Label)

A 6-Month Extension Study of OTO-104 in Meniere's Disease

Open Label Study of OTO-104 in Subjects With Meniere's Disease

Isobide Solution and Meniace Tablets Compared to Monotherapy With Meniace Tablets

OTO-104 for the Treatment of Meniere's Disease

Clinical Trial of Traditional Chinese Diaoshi Jifa Therapy of Meniere's Disease