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

Conditions

Vestibular neuritis

Brief summary

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

Detailed description

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).

Related papers

No related papers found yet.

Interventions

DRUGPrednisolon Actavis 10 mg tabletter

DRUGLaktosmonohydrat SuperTab 11SD

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

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

Secondary

Measure	Time frame
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).	—

Measure

Time frame

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).

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Outcome results

None listed