Dizziness Trials in Disease

Study on Meniere's Disease: Comparing Methylprednisolone and Placebo for Patients with Unilateral Meniere's Disease

This clinical trial is investigating a treatment for Menière's disease, which is a disorder of the inner ear that causes episodes of vertigo, a spinning or dizziness sensation. The condition can also lead to hearing loss, tinnitus (ringing in the ears), and a feeling of fullness or pressure in the affected ear. The study is being conducted in the Netherlands.

Inclusion criteria: To participate in this trial, you must have been diagnosed with unilateral Menière's disease, meaning the condition affects only one ear. You must be over 18 years old and have experienced at least 4 vertigo attacks in the past 6 months. Both males and females are eligible to participate.

Exclusion criteria: You cannot participate if you do not have unilateral Menière's disease or if you fall outside the specified age range. Pregnant women, children, and those unable to provide informed consent are excluded. Patients currently enrolled in another clinical trial, those with allergies to the study medication, or those who have had recent surgery or medical procedures that might interfere with the study cannot join. Additionally, if you have other medical conditions that could affect the study results or are unable to follow study procedures and attend follow-up visits, you will not be eligible.

Trial focus: The main goal of this study is to determine whether injections of methylprednisolone delivered directly into the ear are more effective than a placebo in reducing the frequency of vertigo attacks. The treatment involves intratympanic injections, which means the medication is injected into the middle ear. Throughout the trial, researchers will monitor the frequency of vertigo attacks and assess participants' quality of life, including aspects related to dizziness and tinnitus. The study will track these outcomes over a one-year period.

Investigational drug: The medication being tested is methylprednisolone, a corticosteroid that reduces inflammation and suppresses the immune system. It is administered at a dosage of 62.5 mg/ml through injections directly into the ear. By targeting the affected area directly, the medication aims to reduce the inflammation in the inner ear that contributes to vertigo episodes. The study will compare the effects of methylprednisolone with those of a placebo to evaluate its effectiveness and safety.

During your participation, you will undergo an initial assessment to confirm your eligibility, followed by a treatment phase where you receive the injections at specified intervals. Your health and response to treatment will be closely monitored through regular check-ups, and you may be asked to complete questionnaires about your symptoms and quality of life. At the end of the trial, a final assessment will evaluate the treatment's effectiveness.