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Vestibular DiseasesPhase 4NCT02912182

Acute Unilateral Vestibulopathy and Corticosteroid Treatment

A Phase 4 study testing Betamethasone and Prednisolone in people with Vestibular Diseases and Vestibular Neuronitis, run by Lund University at 3 sites in Sweden.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Vestibular Diseases, Vestibular Neuronitis
What is being tested?
Betamethasone and Prednisolone
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
78 participants
Where
3 sitesSweden
Study dates
Dec 2015to 1 Mar 2021
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • definite unilateral vestibulopathy
  • no pathological HINTS (examination criteria in acute vestibular syndrome)
  • capable of making their own decisions

Who cannot join

  • tinnitus or hearing loss with same debut as vertigo
  • history of bleeding peptic ulcer
  • glaucoma
  • pregnancy or non-acceptance to use anticonception measures during 13 days after debut
  • high blood pressure >180 systolic, 105, diastolic
  • ketoacidosis with a Base Excess >=2
Show all 10Show fewer
  • psychic disorder (not including mild depression)
  • serious infection (neutropenia, tuberculosis)
  • chronic otitis
  • history of vertiginous disease; Ménière, Vertiginous migraine, atypical BPPV

Trial locations and contacts

3 sites in 1 country.

Sweden3 sites

  • Dept OtoRhinoLaryngology

    Helsingborg

  • Dept. Otorhinolaryngology

    Kristianstad

  • Dept. OtoRhinoLaryngology Head and Neck Surgery, Skane University Hospital

    Lund, 22185

Other trials in Sweden

About this study

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.

Read the detailed description

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.

Being tested
Betamethasone, Placebo, Prednisolone
Medical subject headings
Vestibular Diseases, Vestibular Neuronitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BetamethasoneDrug

    Also called Betapred

    Betamethasone intravenous

  • PlaceboDrug

    Also called Sodiumchloride

    Placebo intravenous NaCl intravenous administration Placebo tablets

  • PrednisoloneDrug

    Also called Prednisolon

    Oral tablets

Study groups in NCT02912182
Study groupRoleWhat they receive
PlaceboPlacebo comparatorDay 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
Receives: Drug: Placebo
Short treatmentActive comparatorDay 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
Receives: Drug: Betamethasone; Drug: Prednisolone
Standard treatmentActive comparatorDay 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
Receives: Drug: Betamethasone; Drug: Prednisolone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: after 3 months

  2. 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

    Measured: 1 year

Secondary outcomes (21)

  1. vHIT

    measurement of vestibulo-ocular reflex in all semicircular canals. Gain <0.7 (ratio between head and eye movement) is regarded as pathological

    Measured: 2-5 days after debut

  2. 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

    Measured: 2-5 days after debut,

  3. 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

    Measured: 2-5 days after debut,

  4. Vertigo Diary

    Self-assessment of vertigo according to a Liknert scale daily (1= no vertigo and 10= worst possible vertigo

    Measured: Daily from debut and until no subjective vertigo is experienced, longest 4 weeks

  5. 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)

    Measured: Daily from debut and 14 days onwards (2 days after last treatment)

  6. HADS-enquiry

    Hospital Anxiety and Depression Scale. To asses the degree of anxiety and depression among the patients, often associated with chronic dizziness

    Measured: 3 and 12 months after debut

  7. VSS-enquiry

    Vertigo sympton score, To assess vertigo symptoms

    Measured: 3 and 12 months after debut

  8. DHI-enquiry

    Dizziness Handicap Inventory, to assess the degree of how dizziness affect daily life

    Measured: 3 and 12 months after debut

  9. VHQ-enquiry

    Vertigo Handicap Questionnaire. To assess the degree of how vertigo affect daily life

    Measured: 3 and 12 months after debut

  10. 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

    Measured: At debut and 1 year

  11. Saliva-Cortisol

    Daily measurement of saliva cortisol as measurement of stress

    Measured: At debut and up to 1 week

  12. Adverse Events

    Analysis of adverse events to treatment as well as functional outcome

    Measured: From debut to 1 year after

  13. Hospital stay

    Duration of hospital stay

    Measured: From debut up to 10 days

  14. vHIT

    measurement of vestibulo-ocular reflex in all semicircular canals. Gain <0.7 (ratio between head and eye movement) is regarded as pathological

    Measured: 1 year

  15. 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

    Measured: 1 month

  16. 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

    Measured: 3 months

  17. 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

    Measured: 1 year

  18. 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

    Measured: 3 months

  19. 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

    Measured: 1 year

  20. Sick-leave

    Time needed for sick-leave

    Measured: debut up to 1 year

  21. Daily living

    Time until daily activities are as prior to th disease

    Measured: debut up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2016 (estimated)
  2. Study startDec 2015
  3. Primary completion1 Mar 2021
  4. Study completion1 Mar 2021

Why it stopped: Placebo medication expired

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
78 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02912182
Sponsor's protocol ID
VN-FT-01
Status last verified
Sep 2021
First submitted
15 Sep 2016
Last updated
10 Sep 2021
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Fishman JM, Burgess C, Waddell A. Corticosteroids for the treatment of idiopathic acute vestibular dysfunction (vestibular neuritis). Cochrane Database Syst Rev. 2011 May 11;2011(5):CD008607. doi: 10.1002/14651858.CD008607.pub2.

    PubMed 21563170

  • Strupp M, Zingler VC, Arbusow V, Niklas D, Maag KP, Dieterich M, Bense S, Theil D, Jahn K, Brandt T. Methylprednisolone, valacyclovir, or the combination for vestibular neuritis. N Engl J Med. 2004 Jul 22;351(4):354-61. doi: 10.1056/NEJMoa033280.

    PubMed 15269315

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Betamethasone and Prednisolone in people with Vestibular Diseases and Vestibular Neuronitis, run by Lund University at 3 sites in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Placebo medication expired). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Caloric function (time frame: after 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02912182, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2021.

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