AuthorisedTherapeutic exploratory (Phase II)Interventional

L-Thyroxine for the treatment of acute unilateral vestibulopathy (AUVP): a monocentric, double-blind, placebo-controlled trial (T4U)

This study, called T4U, is investigating a common medicine called L-Thyroxine to see if it can help people who experience sudden, one-sided dizziness. This condition is also known as acute unilateral vestibulopathy (AUVP). The researchers want to find out if this medication can improve how people feel and their daily lives when affected by this dizziness. Half of the participants will receive the L-Thyroxine tablets, and the other half will receive a placebo (a pill with no active medicine, like a sugar pill). Nobody, not even the doctors, will know who is getting which tablet until the end of the study. This helps ensure fair and accurate results. The main focus is to see how your quality of life changes after 14 days of starting treatment.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Klinikum der Universitaet Muenchen AöR

Enrolment target

Start

02 Apr 2026

Patients with acute unilateral vestibulopathy (AUVP)

What is this study about?

This study is investigating a condition called acute unilateral vestibulopathy, or AUVP for short. This is a medical term for when someone suddenly experiences severe dizziness, often feeling like spinning, because of a problem with one of the balance nerves in their inner ear. It can be a very distressing condition that significantly affects daily life.

The researchers want to see if a medication called L-Thyroxine can help people recover from AUVP. L-Thyroxine is a hormone replacement medicine commonly used to treat an underactive thyroid. However, in this study, the researchers are exploring if it might have a different role in helping the balance system recover. This type of research is called 'exploratory' because it's a relatively new idea to use this particular medication for AUVP.

To find out if L-Thyroxine works, the study will compare it to a 'dummy' pill, called a placebo. This means some participants will get the active medication, and others will get a pill that looks the same but contains no medicine. Neither you nor the study team will know which you are receiving. This is a standard and important way to ensure the results are accurate and not due to people expecting to feel better.

Key takeaways

This study investigates if L-Thyroxine helps with sudden, one-sided dizziness (AUVP).
Half of the participants get L-Thyroxine, half get a dummy pill (placebo).
Neither you nor the doctors will know which treatment you receive.
The main goal is to see if your quality of life improves after 14 days.
Participation involves taking tablets and having regular check-ups over 6 months.

Who may be eligible?

To be part of this study, you need to be an adult, 18 years old or older. The study is open to both men and women.

The most important requirement is that you have been recently diagnosed with acute unilateral vestibulopathy (AUVP). This means you've suddenly experienced severe dizziness due to an issue with your inner ear's balance system on one side.

There might be other specific reasons why you can or cannot join, such as other health conditions or medications you are taking. The study team will check all these details carefully with you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you recently been diagnosed with acute unilateral vestibulopathy (sudden one-sided dizziness)?
Are you able to attend regular study appointments for about 6 months?
Do you understand that you might receive a dummy pill instead of the active medication?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given either L-Thyroxine tablets or dummy tablets (a placebo) to take. You won't know which one you are receiving. Over several months, you will have several study visits.

During these visits, the study team will ask you questions about how you are feeling and how your dizziness is affecting your daily life. They will use special questionnaires to understand your 'quality of life' – this means how well you can do everyday things and how you feel generally. This will be checked at different times, including after 7, 14, 45, 60, 90, and 180 days.

They may also perform specific balance tests, such as checking your eye movements (known as 'nystagmus') and how steady you are when standing with your eyes closed. These tests help the researchers understand how your balance system is recovering. The total duration of your active participation, including follow-up, will be around 6 months.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is that the L-Thyroxine medication might help improve your dizziness and overall quality of life sooner than if you didn't take part. Even if you receive the placebo, your participation will help researchers learn more about AUVP, which could help future patients. There might be side effects from the medication, but you will be closely monitored for any changes or problems. L-Thyroxine is generally considered safe, but like all medications, it has potential side effects. You are always free to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Germany

Common questions

What is AUVP?

AUVP stands for acute unilateral vestibulopathy. It's when you suddenly get severe dizziness and balance problems because of an issue with the balance nerve on one side of your inner ear.

What is L-Thyroxine?

L-Thyroxine is a medication usually used to treat an underactive thyroid. In this study, doctors are exploring if it could also help with dizziness from AUVP.

What is a placebo?

A placebo is a 'dummy' pill that looks just like the study medication but doesn't contain any active medicine. It helps researchers fairly compare the effects of the actual drug.

Will I know if I'm getting the medicine or the dummy pill?

No, neither you nor the doctors will know who is getting which treatment until the study is over. This is called 'double-blind' and ensures the results are unbiased.

How long will I be in the study?

If you join the study, your participation, including follow-up, will last for about 6 months.