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Clinical Trials in the EU / 2025-522399-10-00
Authorised, recruiting Phase III

Nordic PREdnisolon for VEstibular NeuriTis Study – an investigator-driven, triple blind, placebo controlled randomized trial

2025-522399-10-00 · tracked via the Priya Life Science EU tracker
Sponsor
Region Vaesterbotten, Umea University
Sponsor type
Hospital/Clinic/Other health care facility, Educational Institution
Therapeutic area
Nervous System Diseases
Decision date
11/02/2026
Enrollment target
404
Sites
Sweden, Denmark, Norway

Condition studied

Vestibular neuritis

Investigational medicinal product(s)

Prednisolon Actavis 10 mg tabletterLaktosmonohydrat SuperTab 11SD

Eligibility

Age group
65+ years, 18-64 years
Sex
Female, Male

Primary endpoint

The primary outcome measure is the between groups mean vertigo symptom scale short form (VSS-SF) score at 6 weeks after randomization.

Endpoint detail

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).

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2025-522399-10-00 on CTIS ↗ ← All trials in the EU