Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05851508 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

Study acronym: PREDMEN
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
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.

Record History

  1. Re-verified, no change to tracked fieldsv3
  2. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of May 1, 2023 to Oct 1, 2023 · Study sites: 0 to 1v2 Show 2 more changesShow less
    • Start date changed from estimate of May 1, 2023 to Oct 1, 2023
    • Study sites: 0 to 1
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
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
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov