LEVOTHYROXINE SODIUM for Acute unilateral vestibulopathy (AUVP) | Vestibular function disorder

Inclusion criteria

• {"criterion_text":"- Patients with AUVP according to the criteria of the International Classification of Vestibular Disorders (ICVD) (i.e. an unambiguous evidence of reduced vestibulo-ocular reflex function on the side opposite the direction of the fast phase of the spontaneous nystagmus, exclusion of central pathologies) (i.e., proven unilateral vestibular hypofunction by vHIT, exclusion of central pathologies) (Strupp et al. 2022)\n- Symptom duration of AUVP < 3 days\n- Signed written informed consent\n- Female participants of childbearing potential: negative β-hCG blood test\n- Patients with reproductive potential who are sexually active with opposite partners have to perform adequate contraception with one of the following methods with high effectiveness: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomised partner, sexual abstinence. The following methods with lower effectiveness will also be accepted: Progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action, male or female condom with or without spermicide, and cap, diaphragm or sponge with spermicide. Contraception has to be used for the first 60 days after the beginning of study medication\n- Patient age ≥ 18 years"}

Exclusion criteria

• {"criterion_text":"- Patients who are unable to give informed consent\n- Episodic or chronic vestibular or balance disorders assessed by medical history: vestibular migraine, Menière’s disease, neuropathy with sensory deficit, postural deficits, genetic disor-ders (i.e. episodic ataxia, CANVAS)\n- Neurodegenerative diseases assessed by medical history: dementia, typical and atypical parkinsonian syndromes\n- Active breast feeding\n- Disorders of the thyroid: Hyperthyroidism defined as lower than normal TSH values and/or elevated serum free T4 and/or T3 levels (based on blood analysis before study inclusion); known thyroid autonomy assessed by medical history)\n- Known allergy to Levothyroxine Sodium\n- Existing treatment with Levothyroxine Sodium\n- Contraindication for the administration of the standard therapy (methylprednisolone)\n- Cardiovascular disorders assessed by medical history: tachycardia or cardiac arrhythmia, heart failure (NYHA score ≥ 2), coronary artery disease, angina pectoris, uncontrolled hyper-tension (blood pressure that remains above goal in spite of concurrent use of three antihyper-tensive agents of different classes), hypopituitarism and/or adrenal insufficiency, past or cur-rent myocarditis, past or current myocardial infarction\n- Participation in other clinical studies within 90 days before study inclusion\n- Patients not able to comply with study requirements as per investigator assessment\n- Lactose intolerance\n- Epilepsy\n- Existing medication with: Amiodarone, tyrosine kinase inhibitors, salicylates, high doses of furosemide (≥ 80mg/day)\n- Medication with coumarin derivatives (e.g. Phenprocoumon)\n- Pathological ECG\n- Psychiatric disorders assessed by medical history: depression, suicidality, bipolar disorders, schizophrenia"}

Primary endpoints

• {"endpoint_text":"- Disease-related quality of life assessed by the change of the DHI value between inclusion and day 14 post study inclusion.","definition_or_measurement_approach":"Change in Dizziness Handicap Inventory (DHI) score from baseline (inclusion) to day 14 post study inclusion."}

Secondary endpoints

• {"endpoint_text":"- Disease-related quality of life assessed by change of the DHI value between inclusion and day 7, 45, 60, 90 and 180 post study inclusion","definition_or_measurement_approach":"Longitudinal change in DHI score at days 7, 45, 60, 90 and 180 compared to baseline."}
• {"endpoint_text":"- Health-related quality of life (assessed by EQ-5D-5L) at day 7, 14, 45, 60, 90, and 180 post study inclusion.","definition_or_measurement_approach":"EQ-5D-5L instrument scores collected at days 7, 14, 45, 60, 90 and 180 post inclusion."}
• {"endpoint_text":"- Slow-phase velocity (SPV) of spontaneous nystagmus at day 7, 45, and 180 days after study inclusion","definition_or_measurement_approach":"Measurement of slow-phase velocity (SPV) of spontaneous nystagmus using video-oculography at days 7, 45 and 180 post inclusion."}
• {"endpoint_text":"- Total postural sway (with eyes closed) at day 7, 45, and 180 post study inclusion","definition_or_measurement_approach":"Posturography measurement of total postural sway with eyes closed at days 7, 45 and 180 post inclusion."}
• {"endpoint_text":"- Rate of conversion to secondary functional dizziness at day 180 post study inclusion","definition_or_measurement_approach":"Proportion of participants meeting criteria for secondary functional dizziness at day 180 post inclusion."}

Germany

Earliest CTIS Part Ii Submission Date

25-03-2026

Latest Decision Or Authorization Date

02-04-2026

Processing Time Days

8

Number Of Sites

1

Number Of Participants

48

Primary sponsor

Full Name

Klinikum der Universitaet Muenchen AöR

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Germany

Contract research organisations

Name

TUM Klinikum Deutsches Herzzentrum

Responsibilities

Sponsor duties codes: 1, 11, 12, 5, 6, 8; contact email: t4u_cro@dhm.mhn.de

Third parties

• {"country":"Germany","full_name":"TUM Klinikum Deutsches Herzzentrum","duties_or_roles":"Codes: 1, 11, 12, 5, 6, 8 (as listed in sponsorDuties)","organisation_type":"Hospital/Clinic/Other health care facility"}