Tympanic membrane hyperaemia 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 vertigo attacks in patients with Menière's disease, a condition affecting the inner ear that causes episodes of spinning sensations, hearing loss, ringing in the ears, and a feeling of fullness or pressure.

Who can participate:

• Adults over 18 years of age
• Diagnosed with unilateral Menière's disease, meaning the condition affects only one ear
• Have experienced at least 4 vertigo attacks in the last 6 months
• Both males and females are eligible

Who cannot participate:

• Patients without a diagnosis of unilateral Menière's disease
• Vulnerable populations such as children, pregnant women, or those unable to give informed consent
• Those with other medical conditions that might interfere with the study
• Patients currently participating in another clinical trial
• Those with allergies or adverse reactions to the study medication
• Patients who have had recent surgery or medical procedures that might affect the study
• Those unable to follow study procedures or attend follow-up visits

What the trial involves:

The main goal of this study is to determine whether methylprednisolone, a corticosteroid medication, is more effective than a placebo in reducing the frequency of vertigo attacks over one year. The medication is delivered through intratympanic injections, which means it is injected directly into the ear. This method allows the medication to target the affected area more effectively.

Participants will receive either methylprednisolone at a dose of 62.5 mg/ml or a placebo injection. Throughout the trial, researchers will monitor the quality of life of participants, including aspects related to dizziness and tinnitus. The study will also track the frequency of vertigo attacks and assess the impact on hearing and overall well-being.

Investigational medication:

Methylprednisolone is a corticosteroid that works by reducing inflammation and suppressing the immune response in the inner ear. By targeting inflammation, the medication aims to decrease the frequency of vertigo episodes. This medication mimics the effects of hormones produced by the adrenal glands and is administered directly into the middle ear through injection to provide more targeted relief from symptoms.

The trial will also consider monitoring the use of other medications such as dexamethasone, triamcinolone, and gentamicin, which are also administered through intratympanic injections, as well as metoclopramide for managing nausea and vomiting that often accompany vertigo attacks.