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.