Clinical trial • Phase III • Neurology|Other
PREDNISOLONE for Vestibular neuritis
Phase III trial of PREDNISOLONE for Vestibular neuritis.
Overview
- Trial Therapeutic Area
- Neurology|Other
- Trial Disease
- Vestibular neuritis
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 13-10-2025
- First CTIS Authorization Date
- 11-02-2026
Trial design
Randomised, prednisolon actavis 10 mg tablets (oral), 10-day tapering oral prednisolone treatment versus placebo (laktosmonohydrat supertab 11sd). product information indicates up to 60 mg/day and a maximum total dose amount listed as 450 mg over a maximum treatment period of 10 days; exact starting dose and taper schedule not specified in available documents.-controlled Phase III trial across 17 sites in Sweden, Denmark, Norway.
- Randomised
- Yes
- Comparator
- Prednisolon Actavis 10 mg tablets (oral), 10-day tapering oral prednisolone treatment versus placebo (Laktosmonohydrat SuperTab 11SD). Product information indicates up to 60 mg/day and a maximum total dose amount listed as 450 mg over a maximum treatment period of 10 days; exact starting dose and taper schedule not specified in available documents.
- Target Sample Size
- 404
- Trial Duration For Participant
- 365
Eligibility
Recruits 404 No vulnerable populations selected. Written informed consent from the participant is required. Individuals with "mental inability, reluctance or language difficulties that result in difficulty to comprehend study information and provide informed consent" are excluded..
- Pregnancy Exclusion
- Among women of childbearing potential: Pregnancy or non-acceptance to take highly effective contraceptive measures during 14 days after inclusion
- Vulnerable Population
- No vulnerable populations selected. Written informed consent from the participant is required. Individuals with "mental inability, reluctance or language difficulties that result in difficulty to comprehend study information and provide informed consent" are excluded.
Inclusion criteria
- {"criterion_text":"- Age ≥18 years old\n- Has given written consent to participate in the study\n- New acute/subacute onset of sustained spinning or non-spinning vertigo of moderate to severe intensity with a duration of at least 3 hours\n- Spontaneous peripheral vestibular nystagmus, i.e. horizontal-torsional, direction-fixed\n- Reduced vestibulo-ocular reflex function on the side opposite the direction of the fast phase of the nystagmus\n- Screening and inclusion within 7 days (inclusive) of onset of continuous symptoms\n- Symptoms present at inclusion"}
Exclusion criteria
- {"criterion_text":"- Symptoms or signs indicating central neurological cause of vertigo, including cranial nerve symptoms outside the vestibular nerve (including sudden concomitant ipsilateral hearing loss)\n- History of psychotic illness\n- History of bleeding gastric ulcer\n- Current vestibular disease severely affecting balance\n- Hypersensitivity to active substance or excipient\n- Ongoing systemic fungal infection, tuberculosis, or active bout of varicella, measles or other serious infection which may be exacerbated by immunosuppressive treatment\n- Recent (4 weeks) or planned (within 2 weeks from randomization) vaccination with live vaccine\n- Pheochromocytoma\n- Systemic sclerosis\n- Severe cardiac failure with pronounced fluid retention\n- Current neurological disease severely affecting balance\n- Any other contraindication to study drug\n- Mental inability, reluctance or language difficulties that result in difficulty to comprehend study information and provide informed consent\n- Among women of childbearing potential: Pregnancy or non-acceptance to take highly effective contraceptive measures during 14 days after inclusion\n- Breast-feeding\n- Ongoing treatment with corticosteroids, including recent intake due to vestibular neuritis (before randomization)\n- History of type 1 diabetes mellitus or insulin-dependent type 2 diabetes mellitus\n- History of bipolar disorder with hypomania or mania"}
Endpoints
Primary endpoints
- {"endpoint_text":"- The primary outcome measure is the between groups mean vertigo symptom scale short form (VSS-SF) score at 6 weeks after randomization.","definition_or_measurement_approach":"Between-groups mean VSS-SF score at 6 weeks after randomization, measured using the Vertigo Symptom Scale Short Form (VSS-SF)."}
Secondary endpoints
- {"endpoint_text":"- Comparison of the between groups mean VSS-SF, DHI and EQ-5D-3L scores at 2 weeks after randomization.","definition_or_measurement_approach":"Between-groups mean scores on VSS-SF, DHI (Dizziness Handicap Inventory) and EQ-5D-3L at 2 weeks post-randomization."}
- {"endpoint_text":"- Comparison of the between groups mean DHI and EQ-5D-3L scores at 6 weeks and 3 and 12 months after randomization, and the between groups VSS-SF at 3 and 12 months after randomization.","definition_or_measurement_approach":"Between-groups mean DHI and EQ-5D-3L at 6 weeks, 3 months and 12 months; between-groups VSS-SF at 3 and 12 months."}
- {"endpoint_text":"- Comparison of the mean video head impulse test (vHIT) measured lateral canal VOR gain change from baseline to 6 weeks and the change in proportions with saccades from baseline to 6 weeks.","definition_or_measurement_approach":"vHIT measured lateral canal VOR gain change from baseline to 6 weeks; change in proportion of participants with saccades from baseline to 6 weeks."}
- {"endpoint_text":"- Comparison of the between groups mean timed 25-foot walk test (T25-FW) at 6 weeks; the between groups mean body sway during standing and walking at 6 weeks; and the between groups mean number of seconds standing on a foam pad at 6 weeks.","definition_or_measurement_approach":"Between-groups comparisons of T25-FW, body sway measures during standing/walking, and seconds standing on a foam pad at 6 weeks."}
- {"endpoint_text":"- BPPV-tests and questionnaires at 6 weeks, comparing proportions with positive tests, and/or questionnaire-positive BPPV between treatment arms.","definition_or_measurement_approach":"Proportion of participants with positive BPPV tests and questionnaire-positive BPPV at 6 weeks compared between arms."}
- {"endpoint_text":"- Register-based search for health economic effects on all levels of care (primary, specialized) and society (sick leave).","definition_or_measurement_approach":"Register-based health economic analysis of resource use at primary and specialized care levels and societal measures such as sick leave."}
Recruitment
- Planned Sample Size
- 404
- Recruitment Window Months
- 42
- Consent Approach
- Written informed consent required from each participant. Subject information and informed consent forms are provided (country-specific versions for Sweden, Denmark and Norway are listed). No assent procedures (study includes adults aged ≥18).
Geography
- Total Number Of Sites
- 17
- Total Number Of Participants
- 404
Sweden
- Earliest CTIS Part Ii Submission Date
- 12-12-2025
- Latest Decision Or Authorization Date
- 13-05-2026
- Processing Time Days
- 152
- Number Of Sites
- 12
- Number Of Participants
- 244
Sites
- Site Name
- Region Vaesternorrland
- Department Name
- Sollefteå hälsocentral
- Principal Investigator Name
- Erik Faergemann
- Principal Investigator Email
- erik-faergemann@umu.se
- Contact Person Name
- Erik Faergemann
- Contact Person Email
- erik-faergemann@umu.se
- Site Name
- Laenssjukhuset I Kalmar Region Kalmar Laen
- Department Name
- ÖNH-kliniken, Kalmar länssjukhus
- Principal Investigator Name
- Julia Sjögren
- Principal Investigator Email
- julia.sjogren@med.lu.se
- Contact Person Name
- Julia Sjögren
- Contact Person Email
- julia.sjogren@med.lu.se
- Site Name
- Region Dalarna
- Department Name
- ÖNH-kliniken, Falu lasarett
- Principal Investigator Name
- Josefine Winberg
- Principal Investigator Email
- josefine.Winberg@regiondalarna.se
- Contact Person Name
- Josefine Winberg
- Contact Person Email
- josefine.Winberg@regiondalarna.se
- Site Name
- Region Skane Skanes Universitetssjukhus
- Department Name
- ÖNH-kliniken, Skånes universitetssjukhus
- Principal Investigator Name
- Mikael Karlberg
- Principal Investigator Email
- mikael.karlberg@med.lu.se
- Contact Person Name
- Mikael Karlberg
- Contact Person Email
- mikael.karlberg@med.lu.se
- Site Name
- Soedra Aelvsborg Hospital Vaestra Goetalandsregionen
- Department Name
- ÖNH-mottagning, Södra Älvsborgs sjukhus
- Principal Investigator Name
- Ellen Lindell
- Principal Investigator Email
- ellen.lindell@vgregion.se
- Contact Person Name
- Ellen Lindell
- Contact Person Email
- ellen.lindell@vgregion.se
- Site Name
- Capio S:t Goerans Sjukhus AB
- Department Name
- Neurologiska kliniken, Capio St Görans sjukhus
- Principal Investigator Name
- Jan Mathé
- Principal Investigator Email
- jan.mathe@capiostgoran.se
- Contact Person Name
- Jan Mathé
- Contact Person Email
- jan.mathe@capiostgoran.se
- Site Name
- Uppsala University Hospital
- Department Name
- ÖNH-kliniken, Akademiska sjukhuset
- Principal Investigator Name
- Christine Ölander
- Principal Investigator Email
- christine.olander@surgsci.uu.se
- Contact Person Name
- Christine Ölander
- Contact Person Email
- christine.olander@surgsci.uu.se
- Site Name
- Region Oerebro Laen
- Department Name
- ÖNH-sektionen, Universitetssjukhuset Örebro
- Principal Investigator Name
- Svante Hugosson
- Principal Investigator Email
- svante.hugosson@oru.se
- Contact Person Name
- Svante Hugosson
- Contact Person Email
- svante.hugosson@oru.se
- Site Name
- Region Vaesterbotten
- Department Name
- Neuro-huvud-hals-centrum, Norrlands universitestssjukhus
- Principal Investigator Name
- Jonatan Salzer
- Principal Investigator Email
- jonatan.salzer@umu.se
- Contact Person Name
- Jonatan Salzer
- Contact Person Email
- jonatan.salzer@umu.se
- Site Name
- Karolinska University Hospital
- Department Name
- ME ÖNH Hörsel och Balans, Karolinska universitetssjukhuset
- Principal Investigator Name
- Tatjana Tomanovic
- Principal Investigator Email
- tatjana.tomanovic@regionstockholm.se
- Contact Person Name
- Tatjana Tomanovic
- Contact Person Email
- tatjana.tomanovic@regionstockholm.se
- Site Name
- Region Vaesternorrland
- Department Name
- Geriatrik, neurologi och rehabiliteringskliniken, Sundsvalls sjukhus
- Principal Investigator Name
- Erik Faergemann
- Principal Investigator Email
- erik.faergemann@umu.se
- Contact Person Name
- Erik Faergemann
- Contact Person Email
- erik.faergemann@umu.se
- Site Name
- Region Joenkoepings Laen
- Department Name
- ÖNH-kliniken, Länssjukhuset Ryhov
- Principal Investigator Name
- Pia Bergman
- Principal Investigator Email
- pia.a.bergman@rjl.se
- Contact Person Name
- Pia Bergman
- Contact Person Email
- pia.a.bergman@rjl.se
Denmark
- Earliest CTIS Part Ii Submission Date
- 21-01-2026
- Latest Decision Or Authorization Date
- 29-04-2026
- Processing Time Days
- 98
- Number Of Sites
- 4
- Number Of Participants
- 120
Sites
- Site Name
- Rigshospitalet
- Department Name
- ØNH afdeling, Rigshospitalet, Copenhagen
- Principal Investigator Name
- Måns Magnusson
- Principal Investigator Email
- mans.magnusson@med.lu.se
- Contact Person Name
- Måns Magnusson
- Contact Person Email
- mans.magnusson@med.lu.se
- Site Name
- Aalborg University Hospital
- Department Name
- ØNH-kirurgisk afdeling, Aalborg Universitetshospital
- Principal Investigator Name
- Dan Dupont Hougaard
- Principal Investigator Email
- d.hougaard@rn.dk
- Contact Person Name
- Dan Dupont Hougaard
- Contact Person Email
- d.hougaard@rn.dk
- Site Name
- Esbjerg Og Grindsted Sygehus
- Department Name
- ØNH afdeling, Esbjerg Sygehus
- Principal Investigator Name
- Helle Elisabeth Agger-Nielsen
- Principal Investigator Email
- helle.elisabeth.agger-nielsen@rsyd.dk
- Contact Person Name
- Helle Elisabeth Agger-Nielsen
- Contact Person Email
- helle.elisabeth.agger-nielsen@rsyd.dk
- Site Name
- Region Midtjylland
- Department Name
- ØNH-kirurgisk afdeling, Aarhus Universitetshospital
- Principal Investigator Name
- Louise Devantier
- Principal Investigator Email
- Louise.Devantier@aarhus.rm.dk
- Contact Person Name
- Louise Devantier
- Contact Person Email
- Louise.Devantier@aarhus.rm.dk
Norway
- Earliest CTIS Part Ii Submission Date
- 20-01-2026
- Latest Decision Or Authorization Date
- 16-02-2026
- Processing Time Days
- 27
- Number Of Sites
- 1
- Number Of Participants
- 40
Sites
- Site Name
- Helse Bergen HF
- Department Name
- ØNH-avdelingen, Haukeland universitetssykehus
- Principal Investigator Name
- Jan Erik Berge
- Principal Investigator Email
- jan.erik.berge@sus.no
- Contact Person Name
- Jan Erik Berge
- Contact Person Email
- jan.erik.berge@sus.no
Sponsor
Primary sponsor
- Full Name
- Region Vaesterbotten
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Sweden
Third parties
- {"country":"Denmark","full_name":"Aalborg University Hospital","duties_or_roles":"sponsorDuties code 1","organisation_type":"Hospital/Clinic/Other health care facility"}
Co-sponsors
- Umea University
Investigational products
- Investigational Product Name
- Prednisolon Actavis 10 mg tabletter
- Active Substance
- PREDNISOLONE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Marketing authorisation in SE (marketingAuthNumber 52713, euMpNumber PRD11998405)
- Frequency
- Up to 60 mg per day
- Maximum Dose
- 60 mg per day
- Investigational Product Name
- Laktosmonohydrat SuperTab 11SD
- Modality
- Other
- Authorisation Status
- No marketing authorisation (manufacturer country IS / no EU product number)
Related trials
Other published trials that may interest you.
- Ropivacaine hydrochloride for Lumbar fusion (lumbar arthrodesis)
- LIDOCAINE HYDROCHLORIDE for Spontaneous subarachnoid hemorrhage|Headache secondary to subarachnoid hemorrhage
- FLORTAUCIPIR (18F) for Alzheimer's disease|Alzheimer's pathology
- O15-WATER for Hydrocephalus|Communicating hydrocephalus|Non-communicating hydrocephalus
- [18F]MC225 for Alzheimer's disease|Sporadic cerebral amyloid angiopathy|Parkinson's disease