Tympanic membrane perforation Trials in Disease

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

This clinical trial is investigating whether injections of methylprednisolone directly into the ear can help reduce vertigo attacks in people with Menière's disease. Vertigo is an intense sensation of spinning or dizziness that can be very disruptive to daily life.

Who can participate:

• Adults over 18 years old
• People diagnosed with unilateral Menière's disease, meaning the condition affects only one ear
• Those who have experienced at least 4 vertigo attacks in the past 6 months
• Both men and women are eligible

Who cannot participate:

• People whose Menière's disease affects both ears
• Those outside the specified age range
• Vulnerable populations including children and pregnant women
• People with other medical conditions that might interfere with the study
• Those currently enrolled in another clinical trial
• People with allergies or adverse reactions to the study medication
• Those who have had recent surgery or medical procedures affecting the ear
• People unable to attend follow-up visits or follow study procedures

What the trial involves:

The main goal of this study is to determine whether methylprednisolone, a corticosteroid medication that reduces inflammation, is more effective than a placebo in controlling vertigo attacks over a one-year period. Participants will receive injections directly into the affected ear, a method called intratympanic injection. The study will track the frequency of vertigo attacks and also monitor quality of life, including issues related to dizziness and tinnitus, which is a ringing or buzzing sound in the ear.

The investigational drug:

Methylprednisolone is a corticosteroid medication used to reduce inflammation and suppress the immune response. In this trial, it is given at a dose of 62.5 mg/ml through injections into the middle ear. By targeting the affected area directly, the medication aims to reduce the inflammation in the inner ear that contributes to vertigo episodes. The trial will also consider other medications such as dexamethasone, triamcinolone, and gentamicin, which are also given through ear injections, as well as metoclopramide to help manage nausea and vomiting during vertigo attacks.

Understanding Menière's disease:

Menière's disease is a disorder of the inner ear that causes episodes of vertigo, fluctuating hearing loss, tinnitus, and a feeling of fullness or pressure in the ear. These vertigo episodes can last from 20 minutes to several hours and are often accompanied by nausea and balance problems. Over time, hearing loss may become permanent, though the frequency of vertigo attacks may decrease. The exact cause is unknown but is believed to be related to abnormal fluid buildup in the inner ear. The unpredictable nature of the symptoms can significantly affect daily life and overall well-being.