Transtympanic Gentamicin vs. Steroids in Refractory Meniere's Disease

Last updated: June 19, 2019
Sponsor: Imperial College London
Overall Status: Completed

Phase

2/3

Condition

Hearing Impairment

Vomiting

Hearing Loss

Treatment

N/A

Clinical Study ID

NCT00802529
CRO1135
  • Ages 18-70
  • All Genders

Study Summary

This trial aims to compare transtympanic steroids against the standard treatment (transtympanic gentamicin) in refractory unilateral Meniere's disease.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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 seriousconcurrent 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 theobjective follow up difficult.

  • Concurrent ear pathology that may interfere with transtympanic treatment (e.g. activemiddle ear disease).

  • Family history of unexplained deafness (possibility of genetic susceptibility togentamicin toxicity).

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

Study Design

Total Participants: 60
Study Start date:
April 01, 2009
Estimated Completion Date:
May 31, 2015

Study Description

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.

Connect with a study center

  • Imperial college Healthcare NHS Trust

    London,
    United Kingdom

    Site Not Available

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