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 study about?

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.

Who Can Join the Study?

  • 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 Study?

  • 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).

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Kupjvfmy dsw Ulvjnzskcqqi Mjurszni Apg Munich Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Not yet recruiting
01.05.2026

Trial locations

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.

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 ID:
2024-519515-34-00
Protocol code:
T4U-LMU-2026
Trial Phase:
Therapeutic exploratory (Phase II)

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