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The Effecttiveness of Intratympanic Methylprednisolon Injections Compared to Placebo in the Treatment of Vertigo Attacks in Meniere's Disease
Sponsor: Leiden University Medical Center
Summary
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.
Official title: A Multicenter, Double-blinded, Randomized, Placebo-controlled Trial to Compare the Effectiveness of Intratympanic Injections methylPREDnisolon Versus Placebo in the Treatment of Vertigo Attacks in MENière's Disease (PREDMEN Trial).
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
148
Start Date
2023-10-01
Completion Date
2027-02-01
Last Updated
2023-12-04
Healthy Volunteers
Yes
Conditions
Interventions
Methylprednisolon
Intratympanal injection with Methylprednisolon 62.5 mg/ ml
Placebo
Intratympanal injection with saline, natriumchloride 0.9%
Locations (1)
Leiden University Medical Centre
Leiden, South Holland, Netherlands