Clinical Trial

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

Study acronym: PREDMEN
Recruiting Phase 3
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Record status
This record was last updated December 4, 2023 (before its estimated May 1, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2023-05-01; most recent amendment 2023-11-28.
Status change: Not Yet Recruiting → Recruiting 2023-10-03
Trial Details
NCT Number NCT05851508
Lead Sponsor Leiden University Medical Center
Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development, Gelre Hospitals, Maasstad Hospital, Maastricht University Medical Center, Medisch Spectrum Twente, HagaZiekenhuis
Conditions Meniere Disease
Enrollment 148 participants
Start Date 2023-10-01
Primary Completion 2026-05-01 (estimated)
Study Completion 2027-02-01 (estimated)
Updated on ClinicalTrials.gov 2023-12-04