Acute Peripheral VestibulopathyPhase 4NCT05024448
Glucocorticosteroid Treatment in Acute Unilateral Vestibulopathy (Vestibular Neuronitis)
A Phase 4 study testing Prednisone in people with Acute Peripheral Vestibulopathy, run by University Hospital, Geneva.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Peripheral Vestibulopathy
- What is being tested?
- Prednisone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- 27 Aug 2013to 9 Jun 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Medical History :
- severe and prolonged rotatory vertigo;
- acute onset, subacute, within 3 days;
- nausea ;
- imbalance.
- Physical examination :
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- 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)
Who cannot join
- 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);
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- 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.
About this study
Official title: Glucocorticosteroid Treatment in Acute Unilateral Vestibulopathy, a Multicentric, Randomized, Double-blind, Placebo-controlled Study
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.
- Conditions
- Acute Peripheral Vestibulopathy
- Being tested
- Prednisone
- Medical subject headings
- Vestibular Neuronitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoneDrug
oral administration, 60mg/d for 10d
| Study group | Role | What they receive |
|---|---|---|
| Prednisone | Active comparator | Prednisone, 60mg/d, for 10 days Receives: Drug: Prednisone |
| Placebo | Placebo comparator | Not described Receives: Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bithermal calorics asymetry
Measured: Day 1
Bithermal calorics asymetry
Measured: Day 21
Bithermal calorics asymetry
Measured: Day 365
Secondary outcomes (1)
Dizziness Hanidcap Inventory (Questionnaire)
min: 0 / max:100, higher score is worse
Measured: Day 1, Day 21, Day 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start27 Aug 2013
- Primary completion9 Jun 2021
- Study completion9 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Peripheral VestibulopathyStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nils Guinand, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05024448
- Sponsor's protocol ID
- PB_2020-00001
- Status last verified
- Aug 2021
- First submitted
- 28 Jul 2021
- Last updated
- 27 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucocorticosteroid Treatment in Acute Unilateral Vestibulopathy, a Multicentric, Randomized, Double-blind, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT05024448
- Acronym / sponsor ID
- PB_2020-00001
- Conditions
- Acute Peripheral Vestibulopathy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 27 Aug 2013 (actual)
- Primary completion
- 9 Jun 2021 (actual)
- Study completion
- 9 Jun 2021 (actual)
- First posted
- 27 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prednisone | Active comparator | Drug: PrednisonePrednisone, 60mg/d, for 10 days |
| Placebo | Placebo comparator | Drug: Prednisone |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- severe and prolonged rotatory vertigo;
- acute onset, subacute, within 3 days;
- nausea ;
- imbalance.
- spontaneous nystagmus beating towards the healthy ear (fast phase);
Key exclusion criteria (20 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prednisoneoral administration, 60mg/d for 10d | Drug | Placebo, Prednisone |
Primary outcome
Bithermal calorics asymetry
Time frame: Day 1
Bithermal calorics asymetry
Time frame: Day 21
Bithermal calorics asymetry
Time frame: Day 365
1 secondary outcome
Dizziness Hanidcap Inventory (Questionnaire)
Time frame: Day 1, Day 21, Day 365
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2021.
- Individual participant dataSharing planned: No
Related trials for Acute Peripheral Vestibulopathy
Not yet recruiting
Quantitative Eye Movement Measurements in Patients with Acute Vestibular Syndrome
Acute Vestibular Syndrome, Vertigo
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prednisone in people with Acute Peripheral Vestibulopathy, run by University Hospital, Geneva.
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 10 inclusion and 20 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: finished, as of the sponsor's last update on 27 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Bithermal calorics asymetry (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Aug 2021.