The Effecttiveness of Intratympanic Methylprednisolon Injections Compared to Placebo in the Treatment of Vertigo Attacks in Meniere's Disease (PREDMEN)
Meniere Disease
About this trial
This is an interventional treatment trial for Meniere Disease focused on measuring Meniere's disease, Methylprednisolon, Intratimpanic corticosteroids, Dizziness, Hearing loss, tinnitus, aural fullness, randomized control trial
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.
Sites / Locations
- Leiden University Medical CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Methylprednisolon
Placebo
Intratympanal injection with Methylprednisolon 62.5 mg/ ml
Intratympanal injection with saline, natriumchloride 0.9%