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

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for Menière’s disease, a condition that affects the inner ear and can cause episodes of vertigo, which is a sensation of spinning or dizziness. The treatment being tested is an injection of methylprednisolone, a type of medication known as a corticosteroid, which is used to reduce inflammation and suppress the immune system. The trial aims to determine if methylprednisolone is more effective than a placebo in reducing the frequency of vertigo attacks in patients with Menière’s disease.

Participants in the study will receive injections directly into the ear, a method known as intratympanic injection. The study will compare the effects of methylprednisolone with those of a placebo over a period of one year. The goal is to see if the treatment can provide better control over vertigo attacks compared to not receiving the active medication. The study will also monitor the quality of life of participants, including aspects related to dizziness and tinnitus, which is a ringing or buzzing noise in one or both ears that may be associated with Menière’s disease.

In addition to methylprednisolone, the study will also consider the use of other medications such as dexamethasone, triamcinolone, and gentamicin, which are also administered through intratympanic injections. The study will track the frequency of these injections and assess their impact on hearing and overall well-being. The trial will also evaluate the use of metoclopramide, a medication that can help manage nausea and vomiting, which are common symptoms during vertigo attacks. The study is designed to provide valuable insights into the effectiveness and safety of these treatments for managing Menière’s disease.

1 joining the trial

Upon joining the trial, you will be informed about the study’s purpose, which is to determine if intratympanic (injected into the ear) methylprednisolone is more effective than a placebo in reducing vertigo attacks in patients with Meniere’s disease.

You will be asked to provide consent to participate in the study, confirming your understanding and willingness to be part of the trial.

2 initial assessment

An initial assessment will be conducted to confirm your eligibility based on criteria such as age and the frequency of vertigo attacks.

This assessment may include a review of your medical history and a physical examination.

3 treatment phase

During the treatment phase, you will receive intratympanic injections of either methylprednisolone or a placebo. The dosage for methylprednisolone is 62.5 mg/ml.

The injections will be administered at specified intervals, as determined by the study protocol.

4 monitoring and follow-up

Throughout the trial, your health and response to the treatment will be closely monitored. This includes regular check-ups and assessments.

You may be asked to complete questionnaires about your quality of life and any changes in your symptoms.

5 end of trial

At the end of the trial, a final assessment will be conducted to evaluate the effectiveness of the treatment.

You will be informed about the results of the study and any further steps, if necessary.

Who Can Join the Study?

Must have been diagnosed with unilateral Menière’s disease. This means the condition affects only one ear.
Must be over 18 years old at the start of the trial.
Must have experienced at least 4 vertigo attacks in the last 6 months. Vertigo is a sensation of spinning or dizziness.
Both males and females can participate.

Who Cannot Join the Study?

Patients who do not have a diagnosis of unilateral Menière’s disease cannot participate. This means the disease affects only one ear.
Patients who are not within the specified age range cannot participate. The age range is typically defined in the study details.
Patients who are part of a vulnerable population cannot participate. This usually includes groups like children, pregnant women, or those unable to give consent.
Patients who have other medical conditions that might interfere with the study cannot participate. These conditions are usually specified in the study details.
Patients who are currently participating in another clinical trial cannot participate.
Patients who have allergies or adverse reactions to the study medication cannot participate.
Patients who have had recent surgery or medical procedures that might affect the study cannot participate.
Patients who are unable to follow the study procedures or attend follow-up visits cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
University Hospital Maastricht	Maastricht	The Netherlands

Other Sites

Site Name	City	Country
Academisch Ziekenhuis Leiden	Leiden	The Netherlands
Sint Franciscus Vlietland Groep Stichting	Rotterdam	The Netherlands
Haga Hospital	Hague	The Netherlands
Gelre Hospitals	Zutphen	The Netherlands
Medisch Spectrum Twente	Enschede	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	01.06.2023

Trial locations

Investigated drugs:

Methylprednisolone is a type of medication known as a corticosteroid. It is used in this trial to help reduce inflammation and swelling in the inner ear, which can help decrease the frequency of vertigo attacks in patients with Meniere’s disease. The medication is administered directly into the ear through an injection, which allows it to target the affected area more effectively. This method of delivery is intended to provide relief from the symptoms of vertigo by reducing the inflammation that contributes to these episodes.

Investigated diseases:

Menière’s disease – Menière’s disease is a disorder of the inner ear that can lead to dizzy spells, known as vertigo, and hearing loss. It typically affects only one ear and is characterized by episodes of vertigo, fluctuating hearing loss, tinnitus, and a feeling of fullness or pressure in the ear. The disease progresses with unpredictable episodes of vertigo that can last from 20 minutes to several hours, often accompanied by nausea and imbalance. Over time, the hearing loss may become permanent, and the frequency of vertigo attacks may decrease. The exact cause of Menière’s disease is unknown, but it is thought to be related to abnormal fluid buildup in the inner ear. The condition can significantly impact the quality of life due to its symptoms and the unpredictability of vertigo attacks.

Trial ID:

2023-503340-13-00

Protocol code:

PREDMEN

NCT ID:

NCT05851508

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?