L-Thyroxine for the treatment of acute unilateral ves-tibulopathy (AUVP): a monocentric, double-blind, pla-cebo-controlled trial. Acronym: T4U

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Klinikum der Universitaet Muenchen AöR

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Decision date (initial)

2026-04-02

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Cures Within Reach (134 N LaSalle Street, '1130, Chicago, IL 60602)

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

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.

Secondary objectives 1

1. Secondary objectives are to assess a therapeutic effect of L-T4 on disease-related quality of life (measured longitudinally by DHI), health-related quality of life (measured longitudinally be EQ-5D-5L), vestibular function and mobility (measured by video-oculography and posturography), and to reduce the rate of conversion to secondary functional dizziness at long term

Conditions and MedDRA coding

Patients with acute unilateral vestibulopathy (AUVP)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. 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)
2. Symptom duration of AUVP < 3 days
3. Signed written informed consent
4. Female participants of childbearing potential: negative β-hCG blood test
5. 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
6. Patient age ≥ 18 years

Exclusion criteria 17

1. Patients who are unable to give informed consent
2. 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)
3. Neurodegenerative diseases assessed by medical history: dementia, typical and atypical parkinsonian syndromes
4. Active breast feeding
5. 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)
6. Known allergy to Levothyroxine Sodium
7. Existing treatment with Levothyroxine Sodium
8. Contraindication for the administration of the standard therapy (methylprednisolone)
9. 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
10. Pathological ECG
11. Psychiatric disorders assessed by medical history: depression, suicidality, bipolar disorders, schizophrenia
12. Existing medication with: Amiodarone, tyrosine kinase inhibitors, salicylates, high doses of furosemide (≥ 80mg/day)
13. Medication with coumarin derivatives (e.g. Phenprocoumon)
14. Lactose intolerance
15. Epilepsy
16. Patients not able to comply with study requirements as per investigator assessment
17. Participation in other clinical studies within 90 days before study inclusion

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Disease-related quality of life assessed by the change of the DHI value between inclusion and day 14 post study inclusion.

Secondary endpoints 5

1. 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
2. Health-related quality of life (assessed by EQ-5D-5L) at day 7, 14, 45, 60, 90, and 180 post study inclusion.
3. Slow-phase velocity (SPV) of spontaneous nystagmus at day 7, 45, and 180 days after study inclusion
4. Total postural sway (with eyes closed) at day 7, 45, and 180 post study inclusion
5. Rate of conversion to secondary functional dizziness at day 180 post study inclusion

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Klinikum der Universitaet Muenchen AöR

Sponsor organisation

Klinikum der Universitaet Muenchen AöR

Address

Marchioninistrasse 15, Hadern Hadern

City

Munich

Postcode

81377

Country

Germany

Scientific contact point

Organisation

Klinikum der Universitaet Muenchen AöR

Contact name

Prof. Dr. med. Andreas Zwergal

Public contact point

Organisation

Klinikum der Universitaet Muenchen AöR

Contact name

Ambulanz des Deutsches Schwindel- und Gleichgewichtszentrum

Third parties 1

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 15 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications