Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruitment pending
Participants planned
404
Countries
3
Sites
17
Vestibular neuritis
Evaluate the effect on vestibular symptoms of a 10-day tapering oral prednisolone treatment compared to placebo in patients with vestibular neuritis.
Key facts
- Sponsor
- Region Vaesterbotten, Umea University
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Otorhinolaryngologic Diseases [C09], Diseases [C] - Nervous System Diseases [C10]
- Decision date (initial)
- 2026-02-16
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
Evaluate the effect on vestibular symptoms of a 10-day tapering oral prednisolone treatment compared to placebo in patients with vestibular neuritis.
Secondary objectives 6
- Evaluate the impact on recovery rate of a 10-day tapering oral prednisolone treatment compared to placebo in patients with vestibular neuritis.
- Evaluate the impact on well-being, quality of life and everyday living and the long-term effect on vestibular symptoms of a 10-day tapering oral prednisolone treatment compared to placebo in patients with vestibular neuritis.
- Investigate the effect on lateral canal vestibuloccular reflex (VOR) recovery of a 10-day tapering oral prednisolone treatment compared to placebo in patients with vestibular neuritis.
- Investigate the effect on walking ability and balance of a 10-day tapering oral prednisolone treatment compared to placebo in patients with vestibular neuritis.
- Evaluate the frequency of benign paroxysmal positional vertigo (BPPV) after vestibular neuritis and if treatment with corticosteroids influence this.
- Investigate the health economic effects among Swedish participants of a 10-day tapering oral prednisolone treatment compared to placebo in patients with vestibular neuritis.
Conditions and MedDRA coding
Vestibular neuritis
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- 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
Exclusion criteria 18
- Symptoms or signs indicating central neurological cause of vertigo, including cranial nerve symptoms outside the vestibular nerve (including sudden concomitant ipsilateral hearing loss)
- 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
- 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
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary outcome measure is the between groups mean vertigo symptom scale short form (VSS-SF) score at 6 weeks after randomization.
Secondary endpoints 6
- Comparison of the between groups mean VSS-SF, DHI and EQ-5D-3L scores at 2 weeks after randomization.
- 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.
- 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.
- 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.
- BPPV-tests and questionnaires at 6 weeks, comparing proportions with positive tests, and/or questionnaire-positive BPPV between treatment arms.
- Register-based search for health economic effects on all levels of care (primary, specialized) and society (sick leave).
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Prednisolon Actavis 10 mg tabletter
PRD11998405 · Product
- Active substance
- Prednisolone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 60 mg milligram(s)
- Max total dose
- 450 mg milligram(s)
- Max treatment duration
- 10 Day(s)
- Authorisation status
- Authorised
- ATC code
- H02AB06 — PREDNISOLONE
- Marketing authorisation
- 52713
- MA holder
- ACTAVIS GROUP PTC EHF.
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Over-encapsulation for blinding (Prednisolone tablets are encapsulated in gelatin capsules).
Placebo 1
Laktosmonohydrat SuperTab 11SD
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Region Vaesterbotten
- Sponsor organisation
- Region Vaesterbotten
- Address
- Koksvagen 11, Alidhem Alidhem
- City
- Umea
- Postcode
- 907 37
- Country
- Sweden
Scientific contact point
- Organisation
- Region Vaesterbotten
- Contact name
- Jonatan Salzer
Public contact point
- Organisation
- Region Vaesterbotten
- Contact name
- Jonatan Salzer
Umea University
- Sponsor organisation
- Umea University
- Address
- Universitetstorget 4, Alidhem Alidhem
- City
- Umea
- Postcode
- 907 36
- Country
- Sweden
Scientific contact point
- Organisation
- Umea University
- Contact name
- Jonatan Salzer
Public contact point
- Organisation
- Umea University
- Contact name
- Jonatan Salzer
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Aalborg University Hospital ORG-100022335
|
Aalborg, Denmark | On site monitoring |
Sponsor responsibilities
- Article 77 compliance
- Region Vaesterbotten
- Contact point sponsor
- Region Vaesterbotten
- Article 77 implementation
- Region Vaesterbotten
Locations
3 EU/EEA countries · 17 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Authorised, recruitment pending | 120 | 4 |
| Norway | Authorised, recruitment pending | 40 | 1 |
| Sweden | Authorised, recruitment pending | 244 | 12 |
| Rest of world | — | 0 | — |
Investigational sites
Aalborg University Hospital
ØNH-kirurgisk afdeling, Aalborg Universitetshospital, Havrevangen 1, 9000, Aalborg
Rigshospitalet
ØNH afdeling, Rigshospitalet, Copenhagen, Inge Lehmanns Vej 7, 2100, Copenhagen Oe
Esbjerg Og Grindsted Sygehus
ØNH afdeling, Esbjerg Sygehus, Finsensgade 35, 6700, Esbjerg
Region Midtjylland
ØNH-kirurgisk afdeling, Aarhus Universitetshospital, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Helse Bergen HF
ØNH-avdelingen, Haukeland universitetssykehus, Haukelandsveien 22, 5021, Bergen
Region Vaesternorrland
Geriatrik, neurologi och rehabiliteringskliniken, Sundsvalls sjukhus, Lasarettsvagen 21, 856 43, Sundsvall
Uppsala University Hospital
ÖNH-kliniken, Akademiska sjukhuset, Akademiska Sjukhuset, 751 85, Uppsala
Region Oerebro Laen
ÖNH-sektionen, Universitetssjukhuset Örebro, Sodra Grev Rosengatan, 701 85, Orebro
Region Skane Skanes Universitetssjukhus
ÖNH-kliniken, Skånes universitetssjukhus, Entregatan 7, 222 42, Lund
Region Vaesterbotten
Neuro-huvud-hals-centrum, Norrlands universitestssjukhus, Koksvagen 11, Alidhem, Umea
Soedra Aelvsborg Hospital Vaestra Goetalandsregionen
ÖNH-mottagning, Södra Älvsborgs sjukhus, Bramhultsvagen 53, Boras Gustav Adolf, Boras
Karolinska University Hospital
ME ÖNH Hörsel och Balans, Karolinska universitetssjukhuset, Halsovagen, Flemingsberg, Huddinge
Capio S:t Goerans Sjukhus AB
Neurologiska kliniken, Capio St Görans sjukhus, Sankt Goransplan 1, Vastermalm, Stockholm
Region Vaesternorrland
Sollefteå hälsocentral, Lasarettsvagen 21, 856 43, Sundsvall
Region Dalarna
ÖNH-kliniken, Falu lasarett, Vasagatan 27, Falu Kristine, Falun
Laenssjukhuset I Kalmar Region Kalmar Laen
ÖNH-kliniken, Kalmar länssjukhus, Lasarettsvagen 8, Kalmar S:t Johannes, Kalmar
Region Joenkoepings Laen
ÖNH-kliniken, Länssjukhuset Ryhov, Lanssjukhuset Ryhov, Sjukhusgatan, Jonkoping
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 21 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_BPPV_2025-522399-10-00 | 1 |
| Protocol (for publication) | D1_Protocol 2025-522399-10-00 | 1.1 |
| Protocol (for publication) | D1_Vestibular rehabilitation instructions_2025-522399-10-00 | 1 |
| Protocol (for publication) | D1_VSS-SF DHI EQ5D-3L_2025-522399-10-00 | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_DK | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_NO | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_SE | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_DK | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_NO | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_SE | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS_DK | 1.2 |
| Subject information and informed consent form (for publication) | L2 Oplysningspligt Aarhus | 1 |
| Subject information and informed consent form (for publication) | L2_Information leaflet participants_DK | 1 |
| Subject information and informed consent form (for publication) | L2_Oplysningspligt Aalborg | 1 |
| Subject information and informed consent form (for publication) | L2_Oplysningspligt Esbjerg | 1 |
| Subject information and informed consent form (for publication) | L2_Oplysningspligt Rigshospitalet | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_SmPC Prednisolone | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_SmPC Prednisolone_SE | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis DK 2025-522399-10-00 | 1.1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis NO 2025-522399-10-00 | 1.1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis SE 2025-522399-10-00 | 1.1 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-10-13 | Sweden | Acceptable 2026-02-11
|
2026-02-11 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-04-02 | Sweden | Acceptable | 2026-05-13 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-04-02 | Acceptable | 2026-04-29 |