Acute Unilateral Vestibulopathy and Corticosteroid Treatment

Lund University

Status and phase: Terminated; Phase 4

Conditions: Vestibular Neuronitis; Vestibular Diseases

Treatments: Drug: Placebo; Drug: Prednisolone; Drug: Betamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT02912182

VN-FT-01

Details and patient eligibility

About

Randomized placebo controlled trial on patients suffering from acute unilateral vestibulopathy. Patients will be randomized into 3 arms; 1) Placebo only, 2) Short corticosteroid treatment (3days) 3) Longer corticosteroid treatment (11 days).

Vestibular function as well as subjective symptoms will be estimated in the acute stage and regularly up to one year after the debut.

Full description

Randomized controlled trial in 3 arms to see if a short or a even shorter period of steroid treatment on patients diagnosed with vestibular neuritis can be as effective as the only comparable study thus far (Strupp et al, NEJM 22, 351(4) 354-61). If a shorter treatment with a lower dose has the same outcome, then more patients might be eligible for the treatment as many are excluded due to risk for adverse effects.

Corticosteroid treatment in acute unilateral vestibulopathy has recently been the subject for a Cochrane review with the conclusion of insufficient evidence for treatment effect and recommend studies with subjective symptom based evaluation together with functional testing.

Patients with acute unilateral vestibulopathy diagnosed within 48hrs after debut. The patients (after acceptance) will be randomized into either of 3 arms and will receive placebo/short treatment (3days)/standard treatment (in Sweden 11 days).

Patients will record subjective symptoms according to Liknert scale during the acute stage and fill out enquiries after 3 and 12 months.

Vestibular function will be assessed with caloric irrigation and video-Head-Impulse-Test (vHIT) as soon as possible after the debut and again after 1, 3 and 12 months.

Enrollment: 78 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• definite unilateral vestibulopathy
• no pathological HINTS (examination criteria in acute vestibular syndrome)
• capable of making their own decisions

Exclusion criteria

• tinnitus or hearing loss with same debut as vertigo
• history of bleeding peptic ulcer
• glaucoma
• pregnancy or non-acceptance to use anticonception measures during 13 days after debut
• high blood pressure >180 systolic, 105, diastolic
• ketoacidosis with a Base Excess >=2
• psychic disorder (not including mild depression)
• serious infection (neutropenia, tuberculosis)
• chronic otitis
• history of vertiginous disease; Ménière, Vertiginous migraine, atypical BPPV

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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78 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Day 1: Intravenous sodium-chloride 2ml Day 2-6: 10 tablets placebo Day 7: 8 tablets placebo Day 8: 6 tablets placebo Day 9: 4 tablets placebo Day 10: 2 tablets placebo Day 11: 1 tablet placebo

Treatment:

Drug: Placebo

Short treatment

Active Comparator group

Description:

Day 1: Intravenous betamethasone 8mg (2ml of 4mg/ml) Day 2-3: 10 tablets prednisolone 5 mg Day 4-6: 10 tablets placebo Day 7: 8 tablets placebo Day 8: 6 tablets placebo Day 9: 4 tablets placebo Day 10: 2 tablets placebo Day 11: 1 tablet placebo

Treatment:

Drug: Betamethasone

Drug: Prednisolone

Standard treatment

Active Comparator group

Description:

Day 1: Intravenous betamethasone 8mg (2ml of 4mg/ml) Day 2-6: 10 tablets prednisolone 5 mg Day 7: 8 tablets prednisolone 5 mg Day 8: 6 tablets prednisolone 5 mg Day 9: 4 tablets prednisolone 5 mg Day 10: 2 tablets prednisolone 5 mg Day 11: 1 tablet prednisolone 5 mg

Treatment:

Drug: Betamethasone

Drug: Prednisolone