Actively Recruiting
Led by Leiden University Medical Center · Updated on 2023-12-04
148
Participants Needed
1
Research Sites
39 weeks
Total Duration
L
Leiden University Medical Center
Lead Sponsor
Z
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborating Sponsor
Researchers are investigating the treatment of Meniere's disease, an inner ear disorder causing vertigo attacks, tinnitus, and hearing loss. The study aims to compare the effects of intratympanic injections of the adrenal cortical hormone methylprednisolone against placebo injections. This multicenter, double-blinded, randomized trial seeks to provide clearer evidence on the effectiveness of methylprednisolone for managing vertigo attacks over one year. Participants will receive either methylprednisolone injections at a dose of 62.5 mg/ml or placebo saline injections directly into the middle ear. Each participant will receive two injections, spaced 14 days apart. Follow-up visits are scheduled at six and twelve months, with telephone check-ins at three and nine months to monitor progress and collect data. Throughout the study, participants will be assessed for changes in vertigo frequency, hearing loss, tinnitus severity, quality of life, and use of escape medications. Safety and adverse events will be recorded daily over the year. Additional measurements will include cost-effectiveness and overall function. The total participation lasts one year, with regular evaluations to track treatment impact and participant well-being.
CONDITIONS
The Effecttiveness of Intratympanic Methylprednisolon Injections Compared to Placebo in the Treatment of Vertigo Attacks in Meniere's Disease
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 14 days
Participants receive intratympanic injections of either methylprednisolone or placebo to treat vertigo attacks associated with Meniere's disease.
2 injection visits over 14 days
Duration - 12 months
Participants attend follow-up visits and receive telephone calls to monitor effectiveness, safety, and quality of life after treatment.
2 in-person visits at 6 and 12 months; 2 telephone follow-ups at 3 and 9 months
Total: 1 location
1
Leiden University Medical Centre
Leiden, South Holland, Netherlands, 2300RC
Actively Recruiting
M
Maud Boreel, MD
B
Babette van Esch, MD, PHD
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Maud Martina Emilie Boreel, Babette van Esch, Tjard R Schermer...
https://pubmed.ncbi.nlm.nih.gov/39209781