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Study on Betahistine Dihydrochloride for Treating Adults with Menière's Disease

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying Menière's disease, a condition that can cause symptoms such as dizziness, nausea, ringing in the ears, and hearing loss. The study is comparing two forms of the medication betahistine dihydrochloride. One form is a prolonged-release tablet taken once daily, and the other is a conventional-release tablet taken twice daily. The purpose of the study is to evaluate the effectiveness and safety of these two forms of betahistine in treating Menière's disease.

Participants in the study will be randomly assigned to one of two groups. One group will receive the prolonged-release form of betahistine, while the other group will receive the conventional-release form. Some participants may also receive a placebo. The study will be conducted over a period of several months, during which participants will take the medication and attend regular check-ups to monitor their symptoms and overall health.

The goal is to determine if the prolonged-release form of betahistine is as effective as the conventional-release form in managing the symptoms of Menière's disease. Participants' experiences with vertigo, hearing, and other related symptoms will be closely monitored and recorded throughout the study. This research aims to provide valuable information that could improve treatment options for individuals living with Menière's disease.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Beginning of the trial

    Upon joining the study, you will be randomly assigned to one of two groups. This process is called randomization and ensures that each participant has an equal chance of receiving either the test medication or the reference medication.

  2. Step 2

    Medication administration

    If assigned to the test group, you will take a prolonged-release tablet of betahistine at a dose of 48 mg once daily. This means you will take one tablet each day.

    If assigned to the reference group, you will take a conventional-release tablet of betahistine at a dose of 24 mg twice daily. This means you will take one tablet in the morning and one in the evening.

  3. Step 3

    Monitoring and assessments

    Throughout the trial, you will be asked to record your experiences with vertigo, including the intensity, duration, and frequency of attacks. This will be done using a self-rating scale called GISFaV.

    You will also be asked to report any changes in your hearing, tinnitus (ringing in the ears), and any pressure sensations you may feel.

  4. Step 4

    Regular check-ups

    You will have regular appointments with the study team to discuss your progress and any side effects you may experience. These check-ups are important to ensure your safety and the effectiveness of the treatment.

  5. Step 5

    End of the trial

    At the end of the study, your overall experience with the treatment will be evaluated. You will be asked to provide feedback on the treatment's effectiveness and your acceptance of it.

    The study team will also assess whether the treatment has been successful in managing your symptoms of Menière's disease.

Who can join the trial?

10 criteria

  • Must be a male or non-pregnant female who is at least 18 years old.
  • Must have a diagnosis of unilateral definite Menière's disease according to specific medical criteria and have a history of frequent vertigo attacks while on betahistine before the study.
  • Must be either:
    • A patient who has never been treated for vertigo and has experienced severe vertigo recently.
    • A patient previously treated with less than 48 mg/day of betahistine who has experienced severe vertigo recently.
    • A patient previously treated with 48 mg/day of betahistine who has experienced vertigo of any severity recently.
    • Must have documented asymmetric sensorineural hearing loss (a type of hearing loss affecting the inner ear).
    • If currently on a low salt diet, must agree to continue this diet throughout the study.
    • Must stop using certain other medications that could interfere with the study at least 7 days before starting the study treatment. These include medications for vertigo, drugs affecting blood flow in the brain, and certain other types of medications.
    • Women who can have children must have a negative pregnancy test at the start of the study and agree to use measures to prevent pregnancy during the study.
    • Must provide informed consent, meaning they understand the study and agree to participate.

Who cannot join the trial?

3 criteria

  • Patients who do not have Menière's disease cannot participate. Menière's disease is a condition that can cause symptoms like dizziness, ringing in the ears, and hearing loss.
  • Patients who are not within the specified age range cannot participate. The age range for this study is not specified in the provided data.
  • Patients who are part of a vulnerable population cannot participate. Vulnerable populations may include groups like children, pregnant women, or those unable to give consent.
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Investigated drugs

  • Betahistine PR

    is a medication designed to help people with Meniere's disease, a condition that can cause symptoms like dizziness, nausea, ringing in the ears, and hearing loss. This medication is a prolonged-release form, which means it is made to release the active ingredient slowly over time. This can help maintain a steady level of the medication in the body throughout the day, potentially improving its effectiveness and making it more convenient to take.

  • Betahistine IR

    is another form of the same medication used to treat Meniere's disease. Unlike the prolonged-release version, this is an immediate-release form, which means it releases the active ingredient more quickly after taking it. This version is typically taken more frequently throughout the day to help manage the symptoms of Meniere's disease, such as dizziness and hearing problems.

What is already known about the treatment

  • Betahistine PR 48 mg

    This medication is taken orally in the form of a prolonged-release tablet, which means it is designed to release the active ingredient slowly over time, allowing for once-daily dosing. It is currently being studied in clinical trials to assess its effectiveness and safety compared to a conventional version of the medication for treating Menière's disease, a condition that can cause symptoms like dizziness, nausea, and hearing loss. Betahistine works by improving blood flow in the inner ear, which helps reduce the pressure that can lead to these symptoms. It is classified as a histamine analog, which means it mimics the action of histamine, a natural substance in the body that helps regulate various functions.

  • Betahistine IR 24 mg

    This medication is administered orally in the form of an immediate-release tablet, which means it releases the active ingredient quickly and is taken twice daily. It is being used as a reference in clinical trials to compare its effectiveness and safety with a prolonged-release version for treating Menière's disease, characterized by symptoms such as dizziness, nausea, and hearing loss. Betahistine helps by enhancing blood circulation in the inner ear, thereby reducing the pressure that can cause these symptoms. It belongs to the pharmacological class of histamine analogs, which are compounds that act like histamine, a natural body chemical involved in various bodily functions.

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, ringing in the ear (tinnitus), and a feeling of fullness or pressure in the ear. The disease often begins with occasional hearing loss, which may become permanent over time. Vertigo attacks can be sudden and severe, causing nausea and vomiting. The frequency and severity of these episodes can vary, with some individuals experiencing frequent attacks and others having long periods without symptoms. Over time, the hearing loss and tinnitus may become more constant.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518347-38-00Protocol code0796-19Estimated enrolment328 patientsSponsorIntas Pharmaceuticals Limited

sourced from the EU Clinical Trials Register and site verification

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