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L-Thyroxine for the treatment of acute unilateral ves-tibulopathy (AUVP): a monocentric, double-blind, pla-cebo-controlled trial. Acronym: T4U
EU CTIS ID: 2024-519515-34-00
What this study is testing
The primary objective of the study is to demonstrate an effect of L-T4 on disease-related quality of life, measured by the change of the Dizziness Handicap Inventory (DHI) value between inclusion and 14 days of treatment.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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)
- Symptom duration of AUVP < 3 days
- Signed written informed consent
- Female participants of childbearing potential: negative β-hCG blood test
- 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
- Patient age ≥ 18 years
You likely can't join if
- Patients who are unable to give informed consent
- Pathological ECG
- Psychiatric disorders assessed by medical history: depression, suicidality, bipolar disorders, schizophrenia
- Existing medication with: Amiodarone, tyrosine kinase inhibitors, salicylates, high doses of furosemide (≥ 80mg/day)
- Medication with coumarin derivatives (e.g. Phenprocoumon)
- Lactose intolerance
See the full eligibility criteria
Who can join
- 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)
- Symptom duration of AUVP < 3 days
- Signed written informed consent
- Female participants of childbearing potential: negative β-hCG blood test
- 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
- Patient age ≥ 18 years
What rules you out
- Patients who are unable to give informed consent
- Pathological ECG
- Psychiatric disorders assessed by medical history: depression, suicidality, bipolar disorders, schizophrenia
- Existing medication with: Amiodarone, tyrosine kinase inhibitors, salicylates, high doses of furosemide (≥ 80mg/day)
- Medication with coumarin derivatives (e.g. Phenprocoumon)
- Lactose intolerance
- Epilepsy
- Patients not able to comply with study requirements as per investigator assessment
- Participation in other clinical studies within 90 days before study inclusion
- 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)
- Neurodegenerative diseases assessed by medical history: dementia, typical and atypical parkinsonian syndromes
- Active breast feeding
- 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)
- Known allergy to Levothyroxine Sodium
- Existing treatment with Levothyroxine Sodium
- Contraindication for the administration of the standard therapy (methylprednisolone)
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.