Acute Unilateral Vestibulopathy and Corticosteroid Treatment

NCT ID: NCT02912182

Last Updated: 2021-09-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2021-03-01

Brief Summary

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.

Detailed 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.

Conditions

Vestibular Diseases; Vestibular Neuronitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo intravenous NaCl intravenous administration Placebo tablets

Short treatment

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

Group Type: ACTIVE_COMPARATOR

Betamethasone

Intervention Type: DRUG

Betamethasone intravenous

Prednisolone

Intervention Type: DRUG

Oral tablets

Standard treatment

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

Group Type: ACTIVE_COMPARATOR

Betamethasone

Intervention Type: DRUG

Betamethasone intravenous

Prednisolone

Intervention Type: DRUG

Oral tablets

Interventions

Betamethasone

Betamethasone intravenous

Intervention Type: DRUG

Placebo

Placebo intravenous NaCl intravenous administration Placebo tablets

Intervention Type: DRUG

Prednisolone

Oral tablets

Intervention Type: DRUG

Other Intervention Names

Betapred; Sodiumchloride; Prednisolon

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lund University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fredrik Tjernström, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Lund University

Locations

Dept OtoRhinoLaryngology

Helsingborg, , Sweden

Dept. Otorhinolaryngology

Kristianstad, , Sweden

Dept. OtoRhinoLaryngology Head and Neck Surgery, Skane University Hospital

Lund, , Sweden

Countries

Sweden

References

Fishman JM, Burgess C, Waddell A. Corticosteroids for the treatment of idiopathic acute vestibular dysfunction (vestibular neuritis). Cochrane Database Syst Rev. 2011 May 11;(5):CD008607. doi: 10.1002/14651858.CD008607.pub2.

Reference Type: BACKGROUND

PMID: 21563170 (View on PubMed)

Strupp M, Zingler VC, Arbusow V, Niklas D, Maag KP, Dieterich M, Bense S, Theil D, Jahn K, Brandt T. Methylprednisolone, valacyclovir, or the combination for vestibular neuritis. N Engl J Med. 2004 Jul 22;351(4):354-61. doi: 10.1056/NEJMoa033280.

Reference Type: RESULT

PMID: 15269315 (View on PubMed)

Other Identifiers

VN-FT-01

Identifier Type: -

Identifier Source: org_study_id