A Phase 4 interventional study of Betamethasone and Placebo in Vestibular Diseases and Vestibular Neuronitis, sponsored by Lund University. Terminated at 3 sites in Sweden. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-09-10.
Sponsored by Lund University · Phase 4, Interventional, and Treatment
Randomized placebo controlled trial on patients suffering from acute unilateral vestibulopathy. Patients will be randomized into 3 arms; 1) Placebo only, 2) Short corticosteroid treatment (3days) 3) Longer corticosteroid treatment (11 days).
Vestibular function as well as subjective symptoms will be estimated in the acute stage and regularly up to one year after the debut.
Randomized controlled trial in 3 arms to see if a short or a even shorter period of steroid treatment on patients diagnosed with vestibular neuritis can be as effective as the only comparable study thus far (Strupp et al, NEJM 22, 351(4) 354-61). If a shorter treatment with a lower dose has the same outcome, then more patients might be eligible for the treatment as many are excluded due to risk for adverse effects.
Corticosteroid treatment in acute unilateral vestibulopathy has recently been the subject for a Cochrane review with the conclusion of insufficient evidence for treatment effect and recommend studies with subjective symptom based evaluation together with functional testing.
Patients with acute unilateral vestibulopathy diagnosed within 48hrs after debut. The patients (after acceptance) will be randomized into either of 3 arms and will receive placebo/short treatment (3days)/standard treatment (in Sweden 11 days).
Patients will record subjective symptoms according to Liknert scale during the acute stage and fill out enquiries after 3 and 12 months.
Vestibular function will be assessed with caloric irrigation and video-Head-Impulse-Test (vHIT) as soon as possible after the debut and again after 1, 3 and 12 months.
170 studies on the registry are indexed under Vestibular Diseases; 41 are open to participants now.
This study's enrollment of 78 is above the median of 46 across 127 interventional studies indexed under Vestibular Diseases.
Browse Vestibular Diseases studies →Lund University is the lead sponsor of 234 studies on the registry; 36 are open to participants now.
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Exclusion Criteria:
Day 1: Intravenous sodium-chloride 2ml Day 2-6: 10 tablets placebo Day 7: 8 tablets placebo Day 8: 6 tablets placebo Day 9: 4 tablets placebo Day 10: 2 tablets placebo Day 11: 1 tablet placebo
Drug: Placebo
Day 1: Intravenous betamethasone 8mg (2ml of 4mg/ml) Day 2-3: 10 tablets prednisolone 5 mg Day 4-6: 10 tablets placebo Day 7: 8 tablets placebo Day 8: 6 tablets placebo Day 9: 4 tablets placebo Day 10: 2 tablets placebo Day 11: 1 tablet placebo
Drug: Betamethasone · Drug: Prednisolone
Day 1: Intravenous betamethasone 8mg (2ml of 4mg/ml) Day 2-6: 10 tablets prednisolone 5 mg Day 7: 8 tablets prednisolone 5 mg Day 8: 6 tablets prednisolone 5 mg Day 9: 4 tablets prednisolone 5 mg Day 10: 2 tablets prednisolone 5 mg Day 11: 1 tablet prednisolone 5 mg
Drug: Betamethasone · Drug: Prednisolone
Betamethasone intravenous
Also known as: Betapred
Placebo intravenous NaCl intravenous administration Placebo tablets
Also known as: Sodiumchloride
Oral tablets
Also known as: Prednisolon
Caloric function
Warm (44deg C) and cold (30 deg C) water irrigation of the ear canals of both ears. Jongkees formula (ratio of response between the ears) is assessed for abnormal or normal function
Time frame: after 3 months
Caloric function
Warm (44deg C) and cold (30 deg C) water irrigation of the ear canals of both ears. Jongkees formula (ratio of response between the ears) is assessed for abnormal or normal function
Time frame: 1 year
vHIT
measurement of vestibulo-ocular reflex in all semicircular canals. Gain \<0.7 (ratio between head and eye movement) is regarded as pathological
Time frame: 2-5 days after debut
Subjective visual vertical/horizontal
Assessment of spatial orientation or utricular function (of the inner ear) as a measure of degree of vestibular loss and of compensation
Time frame: 2-5 days after debut,
Covert saccades
Covert catch-up eye saccades are sometimes seen during vHIT. The origin is unknown. The frequency as well as latency times will be analyzed and correlated to subjective measures
Time frame: 2-5 days after debut,
Vertigo Diary
Self-assessment of vertigo according to a Liknert scale daily (1= no vertigo and 10= worst possible vertigo
Time frame: Daily from debut and until no subjective vertigo is experienced, longest 4 weeks
Sleep Diary
Patients often experience troubled sleep when treated with corticosteroids. How much has not been assessed. The patients will assess their sleep the previous night according to a Liknert scale (1=good nights sleep, 10=hardly slept at all)
Time frame: Daily from debut and 14 days onwards (2 days after last treatment)
HADS-enquiry
Hospital Anxiety and Depression Scale. To asses the degree of anxiety and depression among the patients, often associated with chronic dizziness
Time frame: 3 and 12 months after debut
VSS-enquiry
Vertigo sympton score, To assess vertigo symptoms
Time frame: 3 and 12 months after debut
DHI-enquiry
Dizziness Handicap Inventory, to assess the degree of how dizziness affect daily life
Time frame: 3 and 12 months after debut
VHQ-enquiry
Vertigo Handicap Questionnaire. To assess the degree of how vertigo affect daily life
Time frame: 3 and 12 months after debut
Stress hormones
Measurement of Plasma thyroid hormones, adrenocorticoid hormones (ACTH, Cortisone) as stress indicators in acute vertigo. Baseline will be taken 1 year after debut
Time frame: At debut and 1 year
Saliva-Cortisol
Daily measurement of saliva cortisol as measurement of stress
Time frame: At debut and up to 1 week
Adverse Events
Analysis of adverse events to treatment as well as functional outcome
Time frame: From debut to 1 year after
Hospital stay
Duration of hospital stay
Time frame: From debut up to 10 days
vHIT
measurement of vestibulo-ocular reflex in all semicircular canals. Gain \<0.7 (ratio between head and eye movement) is regarded as pathological
Time frame: 1 year
Subjective visual vertical/horizontal
Assessment of spatial orientation or utricular function (of the inner ear) as a measure of degree of vestibular loss and of compensation
Time frame: 1 month
Subjective visual vertical/horizontal
Assessment of spatial orientation or utricular function (of the inner ear) as a measure of degree of vestibular loss and of compensation
Time frame: 3 months
Subjective visual vertical/horizontal
Assessment of spatial orientation or utricular function (of the inner ear) as a measure of degree of vestibular loss and of compensation
Time frame: 1 year
Covert saccades
Covert catch-up eye saccades are sometimes seen during vHIT. The origin is unknown. The frequency as well as latency times will be analyzed and correlated to subjective measures
Time frame: 3 months
Covert saccades
Covert catch-up eye saccades are sometimes seen during vHIT. The origin is unknown. The frequency as well as latency times will be analyzed and correlated to subjective measures
Time frame: 1 year
Sick-leave
Time needed for sick-leave
Time frame: debut up to 1 year
Daily living
Time until daily activities are as prior to th disease
Time frame: debut up to 1 year
Plan to share: No
This study is terminated, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Betamethasone · Prednisolone