Acute Unilateral Vestibulopathy and Corticosteroid Treatment

NCT02912182 | Terminated Phase 4 DMC

• 1 other identifier: VN-FT-01
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 3

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.

Conditions

Vestibular Diseases; Vestibular Neuronitis

Outcome Measures

Primary Outcomes (2)

• Caloric function

  Warm (44deg C) and cold (30 deg C) water irrigation of the ear canals of both ears. Jongkees formula (ratio of response between the ears) is assessed for abnormal or normal function

  after 3 months

• Caloric function

  Warm (44deg C) and cold (30 deg C) water irrigation of the ear canals of both ears. Jongkees formula (ratio of response between the ears) is assessed for abnormal or normal function

  1 year

Secondary Outcomes (21)

• vHIT

  2-5 days after debut

• Subjective visual vertical/horizontal

  2-5 days after debut,

• Covert saccades

  2-5 days after debut,

• Vertigo Diary

  Daily from debut and until no subjective vertigo is experienced, longest 4 weeks

• Sleep Diary

  Daily from debut and 14 days onwards (2 days after last treatment)

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Short treatment

ACTIVE COMPARATOR

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

Drug: Betamethasone; Drug: Prednisolone

Standard treatment

ACTIVE COMPARATOR

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

Drug: Betamethasone; Drug: Prednisolone

Interventions

Betamethasone DRUG

Betamethasone intravenous

Also known as: Betapred

Short treatment; Standard treatment

Placebo DRUG

Placebo intravenous NaCl intravenous administration Placebo tablets

Also known as: Sodiumchloride

Placebo

Prednisolone DRUG

Oral tablets

Also known as: Prednisolon

Short treatment; Standard treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lund University: lead

Study Sites (3)

Dept OtoRhinoLaryngology

Helsingborg, Sweden

Location

Dept. Otorhinolaryngology

Kristianstad, Sweden

Location

Dept. OtoRhinoLaryngology Head and Neck Surgery, Skane University Hospital

Lund, 22185, Sweden

Location

Related Publications (2)

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

  PMID: 21563170 BACKGROUND

• 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.

  PMID: 15269315 RESULT

MeSH Terms

Conditions

Vestibular Diseases; Vestibular Neuronitis

Interventions

Betamethasone; Prednisolone

Condition Hierarchy (Ancestors)

Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Cranial Nerve Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Fredrik Tjernström, MD, PhD

  Lund University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2016
• First Posted: September 23, 2016
• Study Start: December 1, 2015
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: September 10, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (3)