Efficacy of a 10-day tapering oral prednisolone regimen versus placebo in patients with vestibular neuritis: A randomized, triple-blind, placebo-controlled trial

The primary objective is to evaluate the effect of a 10-day tapering oral prednisolone treatment on vestibular symptoms compared to a placebo in patients diagnosed with vestibular neuritis. This assessment aims to determine the clinical efficacy of corticosteroid administration in managing acute vestibular dysfunction. Secondary objectives include:

• Evaluation of the recovery rate.
• Assessment of well-being, quality of life, and daily living activities, including long-term effects on vestibular symptoms.
• Investigation of vestibulo-ocular reflex (VOR) recovery.
• Evaluation of walking ability and balance.
• Determination of the frequency of benign paroxysmal positional vertigo (BPPV) following the initial episode and the influence of treatment.
• Analysis of health economic effects.

The sponsor did not provide information regarding the total number of participants. The study population consists of patients diagnosed with vestibular neuritis. Eligible participants include both males and females within specific age ranges. Inclusion requires a new acute or subacute onset of sustained vertigo of moderate to severe intensity lasting at least 3 hours. Clinical requirements include spontaneous peripheral vestibular nystagmus that is horizontal-torsional and direction-fixed. Additionally, there must be a reduction in vestibulo-ocular reflex function on the side opposite the fast phase of the nystagmus. Participants must be screened and included within 7 days of the onset of continuous symptoms, and symptoms must be present at the time of inclusion.

This Phase III, triple-blind, placebo-controlled, randomized trial is designed to evaluate the efficacy of a 10-day tapering oral prednisolone treatment compared to a placebo in patients diagnosed with vestibular neuritis. The study methodology involves comparing the effects of the active treatment against a placebo on vestibular symptoms. The research protocol includes a screening visit to confirm eligibility based on specific clinical criteria, such as acute onset of vertigo, nystagmus, and reduced vestibulo-ocular reflex function. Following randomization, the primary outcome is assessed using the Vertigo Symptom Scale Short Form at 6 weeks. Secondary assessments include the Dizziness Handicap Inventory, EQ-5D-3L scores, video head impulse test, timed 25-foot walk test, and various measures of body sway. Follow-up evaluations are scheduled at 2 weeks, 6 weeks, 3 months, and 12 months after randomization to monitor long-term outcomes and potential Benign Paroxysmal Positional Vertigo. The total duration of participant involvement extends through the final 12-month follow-up assessment.

The experimental treatment consists of prednisolone administered as a 10 mg tablet. The total daily dose is 60 mg, delivered via the oral route. The administration follows a 10-day tapering schedule to evaluate its effect on vestibular neuritis symptoms.

The control group receives a placebo consisting of lactose monohydrate. This substance is utilized to maintain the triple-blind design of the randomized trial.

The efficacy of a 10-day tapering oral prednisolone treatment for vestibular neuritis is evaluated through several parameters. The primary outcome measure is the mean Vertigo Symptom Scale Short Form (VSS-SF) score between groups at 6 weeks following randomization. Secondary endpoints include comparisons of mean Dizziness Handicap Inventory (DHI) and EQ-5D-3L scores at 2 weeks, 6 weeks, 3 months, and 12 months after randomization. Additionally, the VSS-SF is assessed at 3 and 12 months.

Further efficacy assessments involve the video head impulse test (vHIT) to measure changes in lateral canal vestibulo-ocular reflex (VOR) gain and the proportion of saccades from baseline to 6 weeks. At the 6-week timepoint, the timed 25-foot walk test (T25-FW), body sway during standing and walking, and the duration of standing on a foam pad are measured. The assessment also includes Benign Paroxysmal Positional Vertigo (BPPV) tests and questionnaires at 6 weeks to compare proportions of positive results. Health economic effects across various levels of care and society are analyzed via a register-based search.