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A study to evaluate the use of levothyroxine sodium in patients with sudden onset of dizziness caused by inner ear issues.

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What is this trial about?

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

This study investigates the treatment of acute unilateral vestibulopathy, a condition that affects the inner ear and causes sudden dizziness or a spinning sensation known as vertigo. The research aims to determine if the medication levothyroxine sodium can improve the quality of life for individuals experiencing these symptoms. Participants will receive either the active medication or a placebo.

The investigation is conducted using a double-blind method, meaning that neither the participants nor the researchers know which specific treatment is being administered to prevent bias. During the study, individuals will take a tablet daily for a period of time to observe how the treatment influences their ability to function in daily life and their overall sense of balance.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    <b>medication administration</b>

    You will take either l-thyroxin (200 micrograms per tablet) or a placebo (a tablet with no active medicine).

    The medication is taken by mouth.

  2. Step 2

    <b>monitoring and evaluations</b>

    Quality of life related to dizziness will be assessed using a questionnaire called the dizziness handicap inventory (dhi) at the start, on day 7, day 14, day 45, day 60, day 90, and day 180.

    Health-related quality of life will be assessed using a questionnaire called eq-5d-5l on day 7, day 14, day 45, day 60, day 90, and day 180.

    Measurements of eye movements (spontaneous nystagmus) will be performed on day 7, day 45, and day 180.

    Tests of body balance (total postural sway with eyes closed) will be performed on day 7, day 45, and day 180.

    The rate of transition to secondary functional dizziness will be recorded on day 180.

Who can join the trial?

7 criteria

  • You must be 18 years of age or older.
  • You must have acute unilateral vestibulopathy, which is a sudden problem with the balance organ in only one ear.
  • The balance problem must be confirmed by tests showing a reduced vestibulo-ocular reflex, which means your eyes do not move correctly to compensate for head movements, and it must be proven that the issue is not caused by problems in the brain (central pathologies).
  • Your symptoms must have started less than 3 days before joining the study.
  • You must provide signed written informed consent, which means you agree to participate after being told all the details of the study.
  • Women who are able to become pregnant must have a negative β-hCG blood test, which is a blood test used to confirm that you are not pregnant.
  • Women who can become pregnant and are sexually active must use highly effective contraception (methods used to prevent pregnancy, such as birth control pills, an IUD, or a partner having a vasectomy) for at least 60 days after starting the study medication.

Who cannot join the trial?

19 criteria

  • People who are unable to provide informed consent, which means being unable to personally agree to take part in the study after understanding all the details.
  • People with a pathological ECG, which means an abnormal test of the electrical activity of the heart.
  • People with psychiatric disorders, such as depression (persistent low mood), suicidality (thoughts of self-harm), bipolar disorders (extreme mood swings), or schizophrenia (a serious mental condition affecting thoughts and perceptions).
  • People currently taking Amiodarone (a heart rhythm medication), tyrosine kinase inhibitors (medications often used in cancer treatment), salicylates (such as aspirin), or high doses of furosemide (a water pill used to reduce swelling).
  • People taking coumarin derivatives, which are types of blood thinners used to prevent blood clots.
  • People with lactose intolerance, which is the inability to digest the sugar found in milk.
  • People with epilepsy, a condition that causes recurring seizures.
  • People who, according to the doctor, cannot follow the specific rules or requirements of the study.
  • People who have participated in other clinical studies within the last 90 days.
  • People with ongoing or recurring vestibular or balance disorders, such as vestibular migraine (migraines that cause dizziness), Menière’s disease (an inner ear disorder), neuropathy (nerve damage causing loss of feeling), postural deficits (difficulty maintaining balance while standing), or genetic disorders like episodic ataxia or CANVAS (conditions passed down through families that affect movement and balance).
  • People with neurodegenerative diseases, which are conditions where brain cells break down over time, such as dementia (memory loss) or parkinsonian syndromes (conditions affecting movement and coordination).
  • People who are currently breastfeeding.
  • People with thyroid disorders, specifically hyperthyroidism, which is when the thyroid gland is too active and produces too much hormone, or thyroid autonomy, where parts of the thyroid work on their own without control.
  • People with a known allergy to Levothyroxine Sodium, which is the specific medication being studied.
  • People who are already taking Levothyroxine Sodium.
  • People who cannot take the standard treatment, methylprednisolone (a type of steroid used to reduce inflammation).
  • People with cardiovascular disorders, such as tachycardia (fast heart rate), cardiac arrhythmia (irregular heart rhythm), heart failure (the heart cannot pump blood well enough), coronary artery disease (clogged heart arteries), angina pectoris (chest pain), or uncontrolled hypertension (high blood pressure that does not respond to medicine).
  • People with hypopituitarism (underactive pituitary gland) or adrenal insufficiency (the body does not produce enough adrenal hormones).
  • People who have had or currently have myocarditis (inflammation of the heart muscle) or a myocardial infarction (a heart attack).
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Investigated drugs

Levothyroxine is a medication used to replace a hormone that the body naturally produces. In this study, it is being tested to see if it can help treat a condition that causes sudden dizziness and balance problems.

What is already known about the treatment

  • Levothyroxine sodium

    This medication is taken as a tablet by mouth and is a well-established hormone replacement therapy used primarily to treat an underactive thyroid. It works by acting as a synthetic version of the natural thyroid hormone, helping to regulate the body's energy levels and metabolic processes at a cellular level. In this study, it is being investigated for its potential role in managing symptoms related to certain inner ear balance issues.

  • Placebo

    This is an inactive substance administered as a tablet by mouth that contains no medicinal ingredients. It is used in clinical trials as a control to help researchers determine if the effects seen in a study are actually caused by the test medication. It serves no therapeutic purpose and is used solely to ensure the scientific accuracy of the study results.

Investigated diseases

Acute unilateral vestibulopathy - This condition occurs when there is a sudden loss of function in one of the inner ear balance organs. It typically manifests as a rapid onset of intense dizziness and spinning sensations. The imbalance often leads to difficulty maintaining stability while standing or walking. As the condition progresses, individuals may experience involuntary eye movements. It can also result in nausea and a general feeling of instability.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-519515-34-00Protocol codeT4U-LMU-2026Estimated enrolment48 patientsSponsorKlinikum Der Universitat Munchen AöR

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