The Effecttiveness of Intratympanic Methylprednisolon Injections Compared to Placebo in the Treatment of Vertigo Attacks in Meniere's Disease

Launched by LEIDEN UNIVERSITY MEDICAL CENTER · May 1, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of injecting a medication called methylprednisolone directly into the inner ear to help reduce vertigo attacks in patients with Ménière's disease. This condition causes episodes of dizziness (vertigo), ringing in the ears (tinnitus), and hearing loss, and researchers want to see if this injection can improve symptoms compared to a placebo (a treatment that doesn't contain active medication). The trial will involve tracking changes in dizziness, tinnitus, hearing, and overall quality of life in participants over a year.

To be eligible for this trial, participants must be at least 18 years old, have experienced at least four vertigo attacks in the last six months, and have specific signs of Ménière's disease affecting only one ear. Those with other serious health conditions or certain prior treatments will not be included. Participants can expect to receive either the active injection or the placebo, and they will be monitored closely throughout the study to assess their symptoms and overall well-being. This study aims to provide more clarity on the effectiveness of methylprednisolone for treating Ménière's disease.

Gender

ALL

Eligibility criteria

• Inclusion criteria:
• • Unilateral, definite MD according to the diagnostic criteria derived from the American Academy Otolaryngology Head and Neck Surgery, Classification Committee of the Bárány Society, European Academy of Otology and Neurotology and International Classification of Vestibular Disorders published in 2015 \[7\] (see Appendix 1):
• • Definite MD Two or more spontaneous episodes of vertigo, each lasting 20 minutes to 12 hours, AND Audiometrically documented low- to medium-frequency sensorineural hearing loss in one ear, defining the affected ear on at least one occasion before, during or after one of the episodes of vertigo, AND Fluctuating aural symptoms (hearing, tinnitus, or fullness) in affected ear (not better accounted for by another vestibular diagnosis)
• • age \> 18 years at the start of the trial.
• • ≥ 4 vertigo attacks over the last 6 months.
• • willing to adhere to daily trial medications and the follow-up assessments.
• • Exclusion criteria
• A potential subject who meets any of the following criteria will be excluded:
• • bilateral MD
• • severe disability (e.g. neurological, orthopaedic, cardiovascular) or serious concurrent illness that might interfere with treatment or follow-up.
• • active additional neuro-otologic disorders that may mimic MD (e.g. vestibular migraine, recurrent vestibulopathy, phobic postural vertigo, vertebro-basilar TIAs, acoustic neuroma).
• • otitis media with effusion based on tympanogram results.
• • history of intratympanic injections with corticosteroid less than 6 months ago.
• • history of intratympanic injections with gentamicin or ear surgery for treating MD.
• • pregnant women and nursing women.