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

Recruiting Phase 3 Interventional Study
Meniere Disease
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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At a Glance
Age
18 – 100
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
148 (estimated)
Sponsor
Leiden University Medical Center · Other
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About This Trial
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 treatmen…
Trial Locations
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Eligibility Criteria
Inclusion criteria: • Unilateral, definite MD according to the diagnostic criteria derived from the American Academy Otolaryngology Head and Neck Surgery, Classification Committee of the Bárány Society, European Academy of Otology and Neurotology and International Classification of Vestibular Disor…
Contacts

Maud Boreel, MD

+3171 526 9111

m.m.e.boreel@lumc.nl

CONTACT

Babette van Esch, MD, PHD

+3171 526 9111

b.f.van_esch@lumc.nl

CONTACT