Prednisone Treatment for Vestibular Neuronitis
2 other identifiers
interventional
17
1 country
4
Brief Summary
The purpose of the study is to investigate the value of steroids in the treatment of vestibular neuronitis. The potential benefits of steroid therapy would be analyzed by the clinical response, self-perceived handicap and laboratory parameters.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Sep 2005
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
January 1, 2006
CompletedFirst Posted
Study publicly available on registry
January 4, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedNovember 6, 2007
July 1, 2007
January 1, 2006
November 4, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical: The presence of static and dynamic nystagmus, positional and positioning nystagmus, and disequilibrium on bedside examination.
12 months
Secondary Outcomes (2)
Functional: Scores on the Dizziness Handicap Inventory questionnaires.
12 months
Laboratory: Caloric lateralization and directional preponderance on electro-oculography (EOG).
12 months
Study Arms (2)
1
EXPERIMENTALPrednisone
2
PLACEBO COMPARATORPlacebo
Interventions
PO, 1 mg/kg body weight, 5 days Short tapering regimen: daily reductions in the dose, 12 days
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of vestibular neuronitis.
- Documentation of unilateral reduced caloric response (caloric asymmetry \>25%) on the EOG caloric study.
You may not qualify if:
- Complaints of new hearing loss, tinnitus, or neurological deficits.
- The presence of previously non-diagnosed sensorineural hearing loss (SNHL)
- History of vestibular dysfunction.
- Patient younger than 18 years of age.
- Known contra-indication to systemic steroids: Unbalanced hypertension, un-controlled diabetes mellitus, immunodeficiency, active peptic disease, and avascular necrosis of the femoral head.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Carmel Medical Centerlead
- Clalit Health Services, Haifa and West Galileecollaborator
- Hillel Yaffe Medical Centercollaborator
- Rambam Health Care Campuscollaborator
- University Health Network, Torontocollaborator
Study Sites (4)
Unit of Otolaryngology Head and Neck Surgery, Hillel Yaffe Medical Center
Hadera, 38100, Israel
Department of Otolaryngology Head and Neck Surgery, Rambam Medical Center
Haifa, 31096, Israel
Department of Otolaryngology Head and Neck Surgery, Carmel Medical Center
Haifa, 34362, Israel
Otoneurolgy Unit, Lin Medical Center, Clalit Health Services
Haifa, 35152, Israel
Related Publications (8)
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: 15269315BACKGROUNDOhbayashi S, Oda M, Yamamoto M, Urano M, Harada K, Horikoshi H, Orihara H, Kitsuda C. Recovery of the vestibular function after vestibular neuronitis. Acta Otolaryngol Suppl. 1993;503:31-4. doi: 10.3109/00016489309128067.
PMID: 8470496BACKGROUNDAriyasu L, Byl FM, Sprague MS, Adour KK. The beneficial effect of methylprednisolone in acute vestibular vertigo. Arch Otolaryngol Head Neck Surg. 1990 Jun;116(6):700-3. doi: 10.1001/archotol.1990.01870060058010.
PMID: 2187486BACKGROUNDArbusow V, Schulz P, Strupp M, Dieterich M, von Reinhardstoettner A, Rauch E, Brandt T. Distribution of herpes simplex virus type 1 in human geniculate and vestibular ganglia: implications for vestibular neuritis. Ann Neurol. 1999 Sep;46(3):416-9. doi: 10.1002/1531-8249(199909)46:33.0.co;2-w.
PMID: 10482275BACKGROUNDBergenius J, Perols O. Vestibular neuritis: a follow-up study. Acta Otolaryngol. 1999;119(8):895-9. doi: 10.1080/00016489950180243.
PMID: 10728930BACKGROUNDShupak A, Nachum Z, Stern Y, Tal D, Gil A, Gordon CR. Vestibular neuronitis in pilots: follow-up results and implications for flight safety. Laryngoscope. 2003 Feb;113(2):316-21. doi: 10.1097/00005537-200302000-00022.
PMID: 12567089BACKGROUNDCameron SA, Dutia MB. Lesion-induced plasticity in rat vestibular nucleus neurones dependent on glucocorticoid receptor activation. J Physiol. 1999 Jul 1;518(Pt 1):151-8. doi: 10.1111/j.1469-7793.1999.0151r.x.
PMID: 10373697BACKGROUNDFife TD, Tusa RJ, Furman JM, Zee DS, Frohman E, Baloh RW, Hain T, Goebel J, Demer J, Eviatar L. Assessment: vestibular testing techniques in adults and children [RETIRED]: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. 2000 Nov 28;55(10):1431-41. doi: 10.1212/wnl.55.10.1431. No abstract available.
PMID: 11094095BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Avi Shupak, MD
Carmel Medical Center and Clalit Health Services, Haifa and West Galilee
- PRINCIPAL INVESTIGATOR
Itzhak Braverman, MD
Hillel Yaffe Medical Center
- PRINCIPAL INVESTIGATOR
Avishai Golz, MD
Rambam Health Care Campus
- PRINCIPAL INVESTIGATOR
Elhanan Greenberg, ND
Carmel Medical Center
- STUDY CHAIR
Avi Shupak, MD
Carmel Medical Center and Clalit Health Services, Haifa and West Galilee
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 1, 2006
First Posted
January 4, 2006
Study Start
September 1, 2005
Study Completion
May 1, 2007
Last Updated
November 6, 2007
Record last verified: 2007-07