About this trial
Ménière's disease is an inner ear disorder in which patients suffer from attacks of vertigo, tinnitus and hearing loss. To date, it is unclear what the best treatment for this condition is. Giving injections in the inner ear with the adrenal cortical hormone methylprednisolone is a treatment that is already widely used, but still there is insufficient evidence in the effectiveness of this treatment. This multicenter trial compares a patient group which receives injections of methylprednisolone to a patient group which receives placebo injections. Subsequently, dizziness, tinnitus, hearing loss and quality of life will be assed and compared for the above mentioned groups, over a period of one year.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Methylprednisolon
- Placebo
Treatment groups
Sponsors and collaborators
Leiden University Medical Center
Lead sponsor
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborator
Gelre Hospitals
Collaborator
Maasstad Hospital
Collaborator
Maastricht University Medical Center
Collaborator
Medisch Spectrum Twente
Collaborator
HagaZiekenhuis
Collaborator