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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-100
SponsorLeiden University Medical Center

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

148 Participants
are divided into 2 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