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CompletedNCT05024448Updated Aug 27, 2021

Glucocorticosteroid Treatment in Acute Unilateral Vestibulopathy (Vestibular Neuronitis)

A Phase 4 interventional study of Prednisone in Acute Peripheral Vestibulopathy, sponsored by University Hospital, Geneva. Completed. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-08-27.

Sponsored by University Hospital, Geneva · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
96
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The vestibular system is a part of the inner ear and functions as a motion sensor. It provides the central nervous system with information about changes of the head position. This information is essential for the proper functioning of the balance system. In particular, it ensures effective postural control and gaze stabilization. Abrupt vestibular deficit is defined as a sudden loss of the vestibular function. In the acute phase the patient presents mainly with intense rotatory vertigo and instability, most often accompanied by nausea. The symptoms are exacerbated by head movements. The diagnosis is made by observation of a spontaneous nystagmus, measurement of a pathological head impulse test and an asymmetric response to caloric tests, in the absence of other neurological symptoms. Although the etiology is unknown, it could be of viral or vascular origin. Symptoms usually regress within a few days or weeks. Vestibular function recovers in about half of the cases, in the other half a central compensation process is set up. The benefit of a 3-week course of corticosteroids has been demonstrated in one study. The dosage has been debated. The aim of this study is to demonstrate the benefit of a 10-day course of oral corticosteroids. The primary objective is to demonstrate a significant reduction in the rate of asymmetry of caloric response and the secondary objective is to demonstrate a significant reduction in the impact of symptoms assessed with the Dizziness Handicap Inventory (DHI) score at 1 year.

02

Conditions studied

  • Acute Peripheral Vestibulopathy

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03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Medical History :

  • severe and prolonged rotatory vertigo;
  • acute onset, subacute, within 3 days;
  • nausea ;
  • imbalance.

Physical examination :

  • spontaneous nystagmus beating towards the healthy ear (fast phase);
  • no evidence of central vestibular lesion;
  • Head impulse test abnormal, at least for the lateral semicircular canal (in some cases, the sign is only detectable for the 2 vertical semicircular canals with specific equipment, mostly not available in current practice);
  • areflexia or hyporeflexia (asymetry > 70% calculated according to the classical Jongkees formula [slow phase velocity of the nystagmus in response to caloric stimulation at (right at 30°C + right at 44°C) - ( left at 30°C + left at 44°C ) / (right 30°C + left 30°C + right 44°C + left at 44°C) x 100], in the caloric test (10 cc in 20 s, at 30 and 44° C)

Exclusion criteria

Exclusion Criteria:

  • history of vestibular disorders other than benign paroxysmal positionning vertigo (BPPV);
  • symptoms lasting more than 3 days;
  • cochlear symptoms (deafness before, during or after vertigo);
  • central oculomotor dysfunction;
  • central vestibular dysfunction;
  • signs of brain dysfunction (e.g. epilepsy);
  • MRI (if done) abnormal central vestibular pathways;
  • psychiatric disease (history of psychiatric disease);
  • glaucoma ;
  • acute infection (herpes simplex, herpes zoster, corneal herpes, chicken pox, tuberculosis);
  • patients already on corticosteroids;
  • severe diabetes (fasting blood glucose > 7 mmol/l);
  • Severe hypertension (systolic >180; diastolic > 110);
  • contraindications to glucocorticoids (peptic ulceration, osteoporosis confirmed by bone density tests or pathological fractures);
  • allergy to glucocorticoids or mannitol
  • malignant disease;
  • cardiac disease (recent myocardial infarction, heart failure);
  • liver dysfunction (cirrhosis)
  • renal insufficiency;
  • Pregnancy or breastfeeding.
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
96 participants (actual)

Study arms

  • Active comparator
    Prednisone

    Prednisone, 60mg/d, for 10 days

    Drug: Prednisone

  • Placebo comparator
    Placebo

    Drug: Prednisone

Interventions

  • DrugPrednisone

    oral administration, 60mg/d for 10d

05

What researchers measure

Primary outcomes

  1. Bithermal calorics asymetry

    Time frame: Day 1

  2. Bithermal calorics asymetry

    Time frame: Day 21

  3. Bithermal calorics asymetry

    Time frame: Day 365

Secondary outcomes

  1. Dizziness Hanidcap Inventory (Questionnaire)

    min: 0 / max:100, higher score is worse

    Time frame: Day 1, Day 21, Day 365

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05024448
Lead sponsor
University Hospital, Geneva
Responsible party
Nils Guinand (Principal Investigator, University Hospital, Geneva) — Principal investigator
First posted
Aug 27, 2021
Start date
Aug 27, 2013
Primary completion
Jun 9, 2021
Completion
Jun 9, 2021
Last update
Aug 27, 2021

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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