Meniere's Disease Clinical Trial
Official title:
Effectiveness of Transtympanic Steroids in Unilateral Ménière's Disease: a Randomised Controlled Double-Blind Trial
This trial aims to compare transtympanic steroids against the standard treatment (transtympanic gentamicin) in refractory unilateral Meniere's disease.
Meniere's disease is characterised by episodic spontaneous vertigo attacks with hearing loss, ringing sounds and fullness in the ear. In one out of five patients, standard first line medical treatment is not effective in controlling vertigo attacks. For these incapacitated patients, gentamicin injections through the ear drum is a well established minimally invasive treatment. Major surgery of the balance organs or nerve, risking complete hearing loss, CSF leak, meningeal infections, are rarely performed nowadays. Gentamicn is very effective in controlling vertigo and acts by chemical ablation of end organs. As hearing and balance organs are entwined around each other, gentamicin treatment does not come without the risk of hearing loss. In fact, meta-analysis shows hearing deterioration in 13% to 35% percent of gentamicin treated patients. On the other hand, steroids are drug of choice for autoimmune inner ear disease and commonly used for sudden hearing loss. They are non toxic drugs without any known side effects during local treatment in ear. We will compare the two in this randomised, double blind trial. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06001593 -
Modulating Auditory Symptoms and Vertigo of Meniere's Disease by Non-invasive Mastoid Electric Stimulation
|
Phase 1/Phase 2 | |
Completed |
NCT03325790 -
SPI-1005 for the Treatment of Patients With Meniere's Disease
|
Phase 2 | |
Completed |
NCT02612337 -
Study of OTO-104 in Subjects With Unilateral Meniere's Disease
|
Phase 3 | |
Completed |
NCT02265393 -
A 1-Year Safety Study of OTO-104 in Subjects With Unilateral Meniere's Disease Located in United Kingdom
|
Phase 2 | |
Completed |
NCT02309099 -
Cochlear Implantation After Labyrinthectomy or a Translabyrinthine Surgical Approach
|
N/A | |
Completed |
NCT01412177 -
OTO-104 for the Treatment of Meniere's Disease
|
Phase 2 | |
Terminated |
NCT02717442 -
Study of OTO-104 in Subjects With Unilateral Meniere's Disease
|
Phase 3 | |
Completed |
NCT01084525 -
OTO-104 for Meniere's Disease
|
Phase 1 | |
Terminated |
NCT02530931 -
Evaluation of Inner Ear and Brain Structures With Contrast-enhanced MRI in Patients With Meniere's Disease
|
Phase 4 | |
Terminated |
NCT02740387 -
Open Label Study of OTO-104 in Subjects With Meniere's Disease
|
Phase 2 | |
Completed |
NCT02158585 -
Study of Lamotrigine to Treat Ménière's Disease
|
Phase 2 | |
Completed |
NCT00145483 -
Sildenafil For Meniere's Disease
|
Phase 4 | |
Suspended |
NCT04026516 -
CAVA: Dizziness Trial
|
N/A | |
Recruiting |
NCT03587701 -
Effects of Anakinra in Subjects With Corticosteroid-resistant/Intolerant Meniere's Disease and Autoimmune Inner Ear Disease
|
Phase 2 | |
Completed |
NCT02080312 -
Magnetic Resonance Imaging Evaluation of Inner Ear Pathology Using Intra-Tympanic Contrast Agent
|
N/A | |
Completed |
NCT01454726 -
Clinical Trial of Traditional Chinese Diaoshi Jifa Therapy of Meniere's Disease
|
Phase 3 | |
Recruiting |
NCT01099046 -
Stress Management Therapy for Meniere's Disease
|
N/A | |
Completed |
NCT00160238 -
Effects of Betaserc on Vestibular Compensation in Patients Suffering From Disabling Meniere's Disease and Having Undergone Vestibular Neurotomy
|
Phase 4 | |
Terminated |
NCT02706730 -
A 6-Month Extension Study of OTO-104 in Meniere's Disease
|
Phase 3 | |
Completed |
NCT02718846 -
Isobide Solution and Meniace Tablets Compared to Monotherapy With Meniace Tablets
|
Phase 4 |