Ongoing Clinical Trials for Meniere’s Disease
Currently, there are 2 ongoing clinical trials investigating new treatments for Meniere’s disease. These studies are testing different medications aimed at reducing vertigo attacks and improving quality of life for patients affected by this inner ear disorder. (Also known as: Menière’s disease, Ménière’s syndrome)
Clinical trial locations
- Netherlands
- Spain
Study on Meniere’s Disease: Comparing Methylprednisolone and Placebo for Patients with Unilateral Meniere’s Disease
This clinical trial is taking place in the Netherlands and is investigating whether methylprednisolone injections can help reduce the frequency of vertigo attacks in patients with Meniere’s disease affecting one ear.
Main focus: The study aims to determine if methylprednisolone, a corticosteroid medication that reduces inflammation, is more effective than a placebo in controlling vertigo attacks over a one-year period. The medication is delivered through intratympanic injection, which means it is injected directly into the ear to target the affected area more effectively.
Who can participate:
- Adults over 18 years old
- Diagnosed with unilateral Meniere’s disease (affecting 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 whose disease affects both ears
- Those belonging to vulnerable populations (such as pregnant women or those unable to give consent)
- Patients with allergies to the study medication
- Those currently participating in another clinical trial
- Patients with other medical conditions that might interfere with the study
- Those unable to attend follow-up visits or follow study procedures
Investigational drug: Methylprednisolone (62.5 mg/ml) is administered as an injection into the ear. As a corticosteroid, it works by reducing inflammation and suppressing the immune response in the inner ear, which may help decrease the frequency of vertigo episodes. The study will also monitor participants’ quality of life, including symptoms like dizziness and tinnitus (ringing in the ears).
Study on Betahistine Dihydrochloride for Treating Adults with Menière’s Disease
This clinical trial is being conducted in Spain and is comparing two different formulations of betahistine dihydrochloride for treating symptoms of Meniere’s disease.
Main focus: The study compares a prolonged-release version of betahistine taken once daily with a conventional-release version taken twice daily. Researchers want to evaluate whether the prolonged-release form is as effective as the conventional form in managing symptoms such as vertigo, hearing loss, tinnitus, and ear pressure. The prolonged-release formulation releases the medication slowly over time, potentially offering more convenient dosing and steady symptom control throughout the day.
Who can participate:
- Males or non-pregnant females aged 18 years or older
- Diagnosed with unilateral definite Meniere’s disease with a history of frequent vertigo attacks while on betahistine
- Must fall into one of these categories: never treated for vertigo with recent severe episodes; previously treated with less than 48 mg/day betahistine with recent severe vertigo; or treated with 48 mg/day betahistine with recent vertigo of any severity
- Have documented asymmetric sensorineural hearing loss (a type of inner ear hearing loss)
- Women of childbearing age must have a negative pregnancy test and use pregnancy prevention measures
- Must stop certain other medications at least 7 days before starting the study
Who cannot participate:
- Patients without a diagnosis of Meniere’s disease
- Those belonging to vulnerable populations such as children, pregnant women, or those unable to give consent
Investigational drugs: The study uses two forms of betahistine dihydrochloride. Betahistine PR 48 mg is a prolonged-release tablet taken once daily that releases the medication slowly over time. Betahistine IR 24 mg is an immediate-release tablet taken twice daily. Both medications work by improving blood flow in the inner ear, which helps reduce the pressure that leads to vertigo, dizziness, and other symptoms. Betahistine is classified as a histamine analog, meaning it mimics the action of histamine, a natural substance in the body.
Throughout the trial, participants will record their experiences with vertigo attacks, including intensity, duration, and frequency. They will also report changes in hearing, tinnitus, and pressure sensations through regular check-ups with the study team.
Summary
Two clinical trials are currently underway to investigate treatments for Meniere’s disease, with one trial in the Netherlands and one in Spain. Both studies focus on reducing vertigo attacks and improving quality of life for patients, but they are testing different therapeutic approaches.
The Netherlands trial is examining methylprednisolone, a corticosteroid delivered through injection directly into the ear, comparing it against a placebo. This represents an anti-inflammatory approach to managing the condition.
The Spain trial is comparing two formulations of betahistine dihydrochloride—a once-daily prolonged-release version versus a twice-daily conventional-release version. This study focuses on optimizing the delivery method of an established medication that improves blood flow in the inner ear.
Both trials are open only to patients with unilateral disease (affecting one ear) and require participants to have experienced recent vertigo attacks. The studies reflect different strategies in managing this complex inner ear disorder: one targeting inflammation, the other improving inner ear circulation. These trials may provide important insights into treatment options that could help patients better control their symptoms and improve their daily lives.
