Recruiting

A Study of Prednisolone Compared to Placebo for Patients with Vestibular Neuritis to Evaluate Effects on Balance and Dizziness Symptoms

Verified siteRegistered drug

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is looking at vestibular neuritis, which is a condition that affects the inner ear and causes sudden spinning sensations or a feeling of being off balance, along with dizziness. These symptoms happen because of inflammation in the nerve that helps control balance. The study will test whether a medicine called prednisolone can help reduce these balance and dizziness symptoms. Prednisolone is a type of steroid medicine that reduces inflammation in the body. Some participants will receive prednisolone tablets while others will receive placebo. The purpose of the study is to see if a 10-day treatment with prednisolone, where the dose is gradually reduced over time, works better than placebo at improving symptoms in people with vestibular neuritis.

Participants in this study will be randomly assigned to receive either prednisolone or placebo for 10 days. The study is designed so that neither the participants nor the doctors will know who is receiving which treatment. To make the treatments look the same, the prednisolone tablets will be placed inside capsules. During the study, participants will be asked to complete questionnaires that measure dizziness and balance symptoms, as well as how these symptoms affect daily life and overall quality of life. These questionnaires will be completed at different times: 2 weeks, 6 weeks, 3 months, and 12 months after starting the treatment.

The study will also include tests to measure how well the balance system is working. These include a video test that measures eye movements when the head is moved quickly, a timed walking test, measurements of body movement while standing and walking, and a test of standing on a foam pad. Some of these tests will be done at the beginning of the study and again at 6 weeks to see if there are any changes. The main focus will be on comparing the dizziness symptom scores between the two groups at 6 weeks after treatment starts. The study will also look at healthcare use and time off work to understand the broader impact of the treatment.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Treatment period with study medication
Your treatment will begin within 7 days of the onset of your continuous symptoms.
You will receive either prednisolone tablets or placebo tablets (inactive tablets that look identical to the active medication). The assignment will be random, and neither you nor your doctor will know which treatment you are receiving.
The treatment consists of oral tablets (taken by mouth) containing either prednisolone 10 mg or placebo.
The treatment will last for 10 days with a tapering schedule, meaning the dose will be gradually reduced over this period.
You must take the tablets according to the specific dosing schedule provided to you.
Step 2
Assessment at 2 weeks after starting treatment
At 2 weeks after you begin the treatment, you will complete several questionnaires to assess your symptoms and quality of life.
These questionnaires include the vertigo symptom scale short form (a questionnaire measuring dizziness and spinning sensations), the dizziness handicap inventory (measuring how dizziness affects your daily activities), and a quality of life questionnaire.
Step 3
Main assessment at 6 weeks after starting treatment
At 6 weeks after starting treatment, you will undergo a comprehensive assessment.
You will complete the same questionnaires as before: the vertigo symptom scale short form, the dizziness handicap inventory, and the quality of life questionnaire.
You will undergo a video head impulse test, which measures how well your inner ear balance system is working by tracking your eye movements while your head is moved quickly.
You will perform a timed 25-foot walk test, where the time it takes you to walk 25 feet will be measured.
Your body sway (how much you move while trying to stand still) will be measured during standing and walking.
You will be asked to stand on a foam pad, and the number of seconds you can maintain balance will be recorded.
Tests for benign paroxysmal positional vertigo (a specific type of dizziness triggered by head position changes) will be performed, along with related questionnaires.
Step 4
Follow-up assessment at 3 months after starting treatment
At 3 months after starting treatment, you will complete the vertigo symptom scale short form, the dizziness handicap inventory, and the quality of life questionnaire.
Step 5
Final assessment at 12 months after starting treatment
At 12 months after starting treatment, you will complete the final assessment.
You will complete the vertigo symptom scale short form, the dizziness handicap inventory, and the quality of life questionnaire.
Information about your use of healthcare services and any sick leave during the study period may be collected from health registers.

Who can join the trial?

7 criteria

You must be 18 years old or older
You must have provided written consent, which means you have agreed in writing to take part in the study
You must have a new sudden onset of continuous spinning sensation or non-spinning dizziness that is moderate to severe in strength and has lasted for at least 3 hours
You must have spontaneous peripheral vestibular nystagmus, which means your eyes make involuntary jerking movements in a specific pattern (horizontal-torsional and direction-fixed) without you trying to move them
You must have reduced function of the vestibulo-ocular reflex on one side, which is a normal reflex that helps your eyes stay focused when your head moves, and this reduced function must be on the side opposite to the direction of the fast eye movement
You must be screened and enrolled in the study within 7 days from when your continuous symptoms started
Your symptoms must still be present when you join the study

Who cannot join the trial?

8 criteria

Central vestibular disorders (problems with balance that come from the brain or brainstem, rather than the inner ear)
Previous episodes of similar symptoms (having had the same balance problems before)
Known chronic vestibular dysfunction (long-term ongoing problems with the balance system in the inner ear)
Contraindications to corticosteroids (reasons why you should not take steroid medications, such as certain infections, severe high blood pressure, or stomach ulcers)
Current use of corticosteroids (already taking steroid medications)
Pregnancy or breastfeeding
Not able to give informed consent (unable to understand and agree to participate in the study)
Not able to complete the study procedures or follow-up visits

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Aalborg University Hospital
Verified
Aalborg, Denmark
Region Midtjylland
Responsive
Aarhus, Denmark
Region Vaesterbotten
Responsive
Umea, Sweden

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

RecruitingNot yet recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Prednisolone is a steroid medication that helps reduce inflammation in the body. In this trial, it is being tested to see if it can help reduce symptoms in patients who have vestibular neuritis, which is a condition that affects the inner ear and causes dizziness and balance problems. The medication is taken by mouth over a period of 10 days with the dose gradually decreasing over time.

Prednisolone

What is already known about the treatment

Prednisolone – Prednisolone is a corticosteroid medication that comes in oral tablet form and is taken by mouth, typically following a tapering schedule where the dose is gradually reduced over time. This medicine works by reducing inflammation in the body through suppressing the immune system's response at the cellular level, specifically by blocking the production of substances that cause swelling and irritation. It is widely used in medical practice to treat various inflammatory conditions, including vestibular neuritis, which is an inner ear disorder that causes sudden dizziness and balance problems. In this clinical trial, researchers are testing whether a 10-day course of prednisolone can help improve symptoms in patients suffering from vestibular neuritis compared to a placebo treatment.

Investigated diseases

Vestibular Neuritis – Vestibular neuritis is a condition that affects the inner ear and the nerve that connects it to the brain. It causes sudden, severe dizziness and problems with balance. The condition occurs when the vestibular nerve becomes inflamed, usually due to a viral infection. Patients typically experience intense spinning sensations, nausea, and difficulty maintaining balance. The symptoms usually appear suddenly and are most severe during the first few days. Over time, the brain learns to compensate for the imbalance, and symptoms gradually improve over weeks to months.