Overview

Transtympanic Gentamicin vs. Steroids in Refractory Meniere's Disease

Status:
Completed
Trial end date:
2015-05-01
Target enrollment:
0
Participant gender:
All
Summary
This trial aims to compare transtympanic steroids against the standard treatment (transtympanic gentamicin) in refractory unilateral Meniere's disease.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Imperial College London
Collaborators:
Imperial College Healthcare NHS Trust
Medical Research Council
Treatments:
Gentamicins
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Criteria
Inclusion Criteria:

- Patients with unilateral Ménière's disease (definite or probable, according to
Committee on Hearing and Equilibrium guidelines, 1995) with hearing loss and
presenting with recurrent vertigo, not responding to medical treatment for at least 6
months will be included. There should be normal, age appropriate hearing in the
contralateral ear.

Exclusion Criteria:

- Patients with Ménière's disease in later stages (not having vertigo attacks).

- Age: patients older than 70 years at the start of the trial.

- Severe disability (e.g. neurological, orthopaedic, cardiovascular) or serious
concurrent illness that might interfere with treatment or follow up.

- Active additional neuro-otological disorders that may mimic Ménière's disease (e.g.
vestibular migraine, vertebro-basilar TIAs, acoustic neuroma) and thus will make the
objective follow up difficult.

- Concurrent ear pathology that may interfere with transtympanic treatment (e.g. active
middle ear disease).

- Family history of unexplained deafness (possibility of genetic susceptibility to
gentamicin toxicity).

- History of known adverse/allergic reaction to steroids or gentamicin.