Endolymphatic hydrops Trials in Disease

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

This trial is investigating whether methylprednisolone injections can help reduce the frequency of vertigo attacks in patients with Menière's disease. The medication is delivered directly into the ear through a method called intratympanic injection. The study will compare the effects of methylprednisolone with those of a placebo over a period of one year.

Main inclusion criteria:

• Diagnosed with unilateral Menière's disease, meaning the condition affects only one ear
• Over 18 years of age
• Experienced at least 4 vertigo attacks in the last 6 months
• Both males and females can participate

Main exclusion criteria:

• No diagnosis of unilateral Menière's disease
• Part of a vulnerable population such as children, pregnant women, or those unable to give consent
• Other medical conditions that might interfere with the study
• Currently participating in another clinical trial
• Allergies or adverse reactions to the study medication
• Recent surgery or medical procedures that might affect the study
• Unable to follow study procedures or attend follow-up visits

Focus and goal of the trial: The main goal is to determine whether intratympanic methylprednisolone is more effective than a placebo in reducing vertigo attacks. The study will also monitor participants' quality of life, including aspects related to dizziness and tinnitus. Additionally, the trial will track the impact of the treatment on hearing and overall well-being throughout the one-year study period.

Investigational drug: Methylprednisolone is a corticosteroid medication that reduces inflammation and suppresses the immune response. In this trial, it is injected directly into the ear at a dosage of 62.5 mg/ml. By targeting the affected area more effectively, the medication aims to reduce the inflammation that contributes to vertigo episodes. The treatment is designed to provide relief from symptoms and potentially decrease the frequency of vertigo attacks.