Actively Recruiting
The Effecttiveness of Intratympanic Methylprednisolon Injections Compared to Placebo in the Treatment of Vertigo Attacks in Meniere's Disease
Led by Leiden University Medical Center · Updated on 2023-12-04
148
Participants Needed
1
Research Sites
174 weeks
Total Duration
On this page
Sponsors
L
Leiden University Medical Center
Lead Sponsor
Z
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Effecttiveness of Intratympanic Methylprednisolon Injections Compared to Placebo in the Treatment of Vertigo Attacks in Meniere's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults over 18 years old
- Diagnosis of unilateral, definite Meniere's disease based on established criteria including two or more spontaneous vertigo episodes lasting 20 minutes to 12 hours
- Audiometrically documented low- to medium-frequency sensorineural hearing loss in one ear
- Fluctuating ear symptoms such as hearing loss, tinnitus, or fullness in the affected ear
- Experienced 4 or more vertigo attacks in the last 6 months
- Willing to follow daily trial medication and attend follow-up assessments
You will not qualify if you...
- Diagnosis of bilateral Meniere's disease
- Severe disability or serious illness that could interfere with treatment or follow-up
- Other active neuro-otologic disorders mimicking Meniere's disease (e.g., vestibular migraine, recurrent vestibulopathy, phobic postural vertigo, vertebro-basilar TIAs, acoustic neuroma)
- Otitis media with effusion as shown by tympanogram
- Intratympanic corticosteroid injections within the past 6 months
- Previous intratympanic gentamicin injections or ear surgery for Meniere's disease
- Pregnant or nursing women
AI-Screening
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Trial Site Locations
Total: 1 location
1
Leiden University Medical Centre
Leiden, South Holland, Netherlands, 2300RC
Actively Recruiting
Research Team
M
Maud Boreel, MD
CONTACT
B
Babette van Esch, MD, PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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