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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario Y Politecnico La Fe	Valencia	Spain

Other Sites

Site Name	City	Country
Hospital Del Mar	Barcelona	Spain
El Hospital Universitario De Gran Canaria Dr. Negrin	Las Palmas De Gran Canaria	Spain
Hospital Universitario Virgen Macarena	Sevilla	Spain
Hospital Clinic De Barcelona	Barcelona	Spain
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Ccjnviua Hsvdixicdtcl du Plrodoyqye &jydtmb Hfxzrakv dt Mqraxjleh	Pontevedra	Spain
Fdwmelnor Pmxu Lx Ivrinbulczzpj Biccbxegi Dpt Hahpptda Uzjhtibcbvfjm Lm Ptj	Madrid	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	08.06.2022

Trial locations

Investigated drugs:

Betahistine Dihydrochloride

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.

Investigated diseases:

Meniere's disease

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 ID:

2024-518347-38-00

Protocol code:

0796-19

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

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