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Nordic PREdnisolon for VEstibular NeuriTis Study – an investigator-driven, triple blind, placebo controlled randomized trial
EU CTIS ID: 2025-522399-10-00
What this study is testing
Evaluate the effect on vestibular symptoms of a 10-day tapering oral prednisolone treatment compared to placebo in patients with vestibular neuritis.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥18 years old
- Has given written consent to participate in the study
- New acute/subacute onset of sustained spinning or non-spinning vertigo of moderate to severe intensity with a duration of at least 3 hours
- Spontaneous peripheral vestibular nystagmus, i.e. horizontal-torsional, direction-fixed
- Reduced vestibulo-ocular reflex function on the side opposite the direction of the fast phase of the nystagmus
- Screening and inclusion within 7 days (inclusive) of onset of continuous symptoms
You likely can't join if
- Symptoms or signs indicating central neurological cause of vertigo, including cranial nerve symptoms outside the vestibular nerve (including sudden concomitant ipsilateral hearing loss)
- History of psychotic illness
- History of bleeding gastric ulcer
- Current vestibular disease severely affecting balance
- Hypersensitivity to active substance or excipient
- Ongoing systemic fungal infection, tuberculosis, or active bout of varicella, measles or other serious infection which may be exacerbated by immunosuppressive treatment
See the full eligibility criteria
- Age ≥18 years old
- Has given written consent to participate in the study
- New acute/subacute onset of sustained spinning or non-spinning vertigo of moderate to severe intensity with a duration of at least 3 hours
- Spontaneous peripheral vestibular nystagmus, i.e. horizontal-torsional, direction-fixed
- Reduced vestibulo-ocular reflex function on the side opposite the direction of the fast phase of the nystagmus
- Screening and inclusion within 7 days (inclusive) of onset of continuous symptoms
- Symptoms present at inclusion
- Symptoms or signs indicating central neurological cause of vertigo, including cranial nerve symptoms outside the vestibular nerve (including sudden concomitant ipsilateral hearing loss)
- History of psychotic illness
- History of bleeding gastric ulcer
- Current vestibular disease severely affecting balance
- Hypersensitivity to active substance or excipient
- Ongoing systemic fungal infection, tuberculosis, or active bout of varicella, measles or other serious infection which may be exacerbated by immunosuppressive treatment
- Recent (4 weeks) or planned (within 2 weeks from randomization) vaccination with live vaccine
- Pheochromocytoma
- Systemic sclerosis
- Severe cardiac failure with pronounced fluid retention
- Current neurological disease severely affecting balance
- Any other contraindication to study drug
- Mental inability, reluctance or language difficulties that result in difficulty to comprehend study information and provide informed consent
- Among women of childbearing potential: Pregnancy or non-acceptance to take highly effective contraceptive measures during 14 days after inclusion
- Breast-feeding
- Ongoing treatment with corticosteroids, including recent intake due to vestibular neuritis (before randomization)
- History of type 1 diabetes mellitus or insulin-dependent type 2 diabetes mellitus
- History of bipolar disorder with hypomania or mania
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.