Vestibular DiseasesPhase 2NCT00271791
Prednisone Treatment for Vestibular Neuronitis
A Phase 2 study testing Prednisone in people with Vestibular Diseases and Vestibular Neuronitis, run by Carmel Medical Center at 4 sites in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vestibular Diseases, Vestibular Neuronitis
- What is being tested?
- Prednisone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 4 sitesIsrael
- Study dates
- Sep 2005to May 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of vestibular neuronitis.
- Documentation of unilateral reduced caloric response (caloric asymmetry >25%) on the EOG caloric study.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
Israel4 sites
Unit of Otolaryngology Head and Neck Surgery, Hillel Yaffe Medical Center
Hadera, 38100
Department of Otolaryngology Head and Neck Surgery, Rambam Medical Center
Haifa, 31096
Department of Otolaryngology Head and Neck Surgery, Carmel Medical Center
Haifa, 34362
Otoneurolgy Unit, Lin Medical Center, Clalit Health Services
Haifa, 35152
About this study
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.
Read the detailed description
Vestibular neuronitis is the second most common cause of peripheral vestibulopathy (the first being benign paroxysmal positional vertigo) with incidence of about 3.5/100000. Currently vestibular neuronitis is explained by a viral pathogenesis.
Vestibular neuronitis is considered to have a benign course. The static rotatory vertigo and disequilibrium, present even when the patient is completely at rest, subside in most cases within a few days, and a gradual return to daily activities is the rule. However, it has been shown that there is generally incomplete restoration of peripheral function, and clinical recovery is achieved by proprioceptive and visual substitution for the unilateral vestibular deficit, combined with central vestibular compensation of the imbalance in vestibular tone. Although vestibular neuronitis is usually restricted to one attack, several studies have reported continuous or episodic vertigo or unsteadiness in 43% -53% of patients. The main residua include impaired vision and disequilibrium during walking and especially during head movement toward the affected ear. The rate of positive finding on vestibular evaluation may reach 60%. However, vestibular impairment as reflected by positive bedside testing and vestibular laboratory evaluation is not necessarily accompanied by subjective complaints and does not always reflect the level of incapacity.
The assumed HSV-1 etiology of vestibular neuronitis and the reported benefit of the combination of steroids and acyclovir in Bell's palsy suggest similar advantage in the treatment of vestibular neuronitis. Also, glucocorticoid receptors activation was reported to enhance vestibular compensation after acute peripheral vestibular insults in various animal models. A recent study investigated the effect of prednisolone versus valacyclovir and placebo on canal paresis in vestibular neuronitis patients. It was found that steroid treatment significantly improved peripheral vestibular function to the extent reflected by the caloric testing. However, bedside findings, patients' complaints and daily handicap were not evaluated. The relevance of the EOG caloric test results to clinical improvement could be argued in light of a previous report showing no correlation between EOG findings and residual symptoms in a long-term follow-up of vestibular neuronitis patients, and the finding that corticosteroid therapy had no effect on symptoms despite significant recovery of the caloric-test results.
The purpose of the study:
Prospective controlled longitudinal 12-month evaluation of 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 EOG laboratory parameters.
- Conditions
- Vestibular Diseases, Vestibular Neuronitis
- Being tested
- Prednisone
- Keywords
- Vestibular Neuronitis, Vestibular Function Tests, Vestibular Adaptation, Steroids
- Medical subject headings
- Vestibular Diseases, Vestibular Neuronitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoneDrug
PO, 1 mg/kg body weight, 5 days Short tapering regimen: daily reductions in the dose, 12 days
PrednisoneDrug
PO, Placebo, 17 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Prednisone Receives: Drug: Prednisone |
| 2 | Placebo comparator | Placebo Receives: Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical: The presence of static and dynamic nystagmus, positional and positioning nystagmus, and disequilibrium on bedside examination.
Measured: 12 months
Secondary outcomes (2)
Functional: Scores on the Dizziness Handicap Inventory questionnaires.
Measured: 12 months
Laboratory: Caloric lateralization and directional preponderance on electro-oculography (EOG).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2006 (estimated)
- Study startSep 2005
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Vestibular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carmel Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Clalit Health Services, Haifa and West Galilee, Hillel Yaffe Medical Center, Rambam Health Care Campus, University Health Network, Toronto
- Investigators
- Avi Shupak, MD, Principal investigator, Carmel Medical Center and Clalit Health Services, Haifa and West GalileeItzhak Braverman, MD, Principal investigator, Hillel Yaffe Medical CenterAvishai Golz, MD, Principal investigator, Rambam Health Care CampusElhanan Greenberg, ND, Principal investigator, Carmel Medical CenterAvi Shupak, MD, Study chair, Carmel Medical Center and Clalit Health Services, Haifa and West Galilee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00271791
- Sponsor's protocol ID
- 42352
- Other IDs
- 20050277
- Status last verified
- Jul 2007
- First submitted
- 1 Jan 2006
- Last updated
- 6 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 15269315Ohbayashi 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.
PubMed 8470496Ariyasu 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.
PubMed 2187486Arbusow 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.
PubMed 10482275Bergenius J, Perols O. Vestibular neuritis: a follow-up study. Acta Otolaryngol. 1999;119(8):895-9. doi: 10.1080/00016489950180243.
PubMed 10728930Shupak 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.
PubMed 12567089Cameron 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.
PubMed 10373697Fife 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.
PubMed 11094095
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prednisone Treatment for Vestibular Neuronitis
- ClinicalTrials.gov ID
- NCT00271791
- Acronym / sponsor ID
- 42352
- Conditions
- Vestibular Diseases, Vestibular Neuronitis
- Keywords
- Vestibular Neuronitis, Vestibular Function Tests, Vestibular Adaptation, Steroids
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Carmel Medical CenterUniversity, hospital or other
- Collaborators
- Clalit Health Services, Haifa and West Galilee, Hillel Yaffe Medical Center, Rambam Health Care Campus, University Health Network, Toronto
- Study start
- Sep 2005
- Study completion
- May 2007 (actual)
- First posted
- 4 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Vestibular neuronitis is the second most common cause of peripheral vestibulopathy (the first being benign paroxysmal positional vertigo) with incidence of about 3.5/100000. Currently vestibular neuronitis is explained by a viral pathogenesis.
Vestibular neuronitis is considered to have a benign course. The static rotatory vertigo and disequilibrium, present even when the patient is completely at rest, subside in most cases within a few days, and a gradual return to daily activities is the rule. However, it has been shown that there is generally incomplete restoration of peripheral function, and clinical recovery is achieved by proprioceptive and visual substitution for the unilateral vestibular deficit, combined with central vestibular compensation of the imbalance in vestibular tone. Although vestibular neuronitis is usually restricted to one attack, several studies have reported continuous or episodic vertigo or unsteadiness in 43% -53% of patients. The main residua include impaired vision and disequilibrium during walking and especially during head movement toward the affected ear. The rate of positive finding on vestibular evaluation may reach 60%. However, vestibular impairment as reflected by positive bedside testing and vestibular laboratory evaluation is not necessarily accompanied by subjective complaints and does not always reflect the level of incapacity.
The assumed HSV-1 etiology of vestibular neuronitis and the reported benefit of the combination of steroids and acyclovir in Bell's palsy suggest similar advantage in the treatment of vestibular neuronitis. Also, glucocorticoid receptors activation was reported to enhance vestibular compensation after acute peripheral vestibular insults in various animal models. A recent study investigated the effect of prednisolone versus valacyclovir and placebo on canal paresis in vestibular neuronitis patients. It was found that steroid treatment significantly improved peripheral vestibular function to the extent reflected by the caloric testing. However, bedside findings, patients' complaints and daily handicap were not evaluated. The relevance of the EOG caloric test results to clinical improvement could be argued in light of a previous report showing no correlation between EOG findings and residual symptoms in a long-term follow-up of vestibular neuronitis patients, and the finding that corticosteroid therapy had no effect on symptoms despite significant recovery of the caloric-test results.
The purpose of the study:
Prospective controlled longitudinal 12-month evaluation of 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 EOG laboratory parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: PrednisonePrednisone |
| 2 | Placebo comparator | Drug: PrednisonePlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of vestibular neuronitis.
- Documentation of unilateral reduced caloric response (caloric asymmetry >25%) on the EOG caloric study.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrednisonePO, 1 mg/kg body weight, 5 days Short tapering regimen: daily reductions in the dose, 12 days | Drug | 1 |
| PrednisonePO, Placebo, 17 days | Drug | 2 |
Primary outcome
Clinical: The presence of static and dynamic nystagmus, positional and positioning nystagmus, and disequilibrium on bedside examination.
Time frame: 12 months
2 secondary outcomes
Functional: Scores on the Dizziness Handicap Inventory questionnaires.
Time frame: 12 months
Laboratory: Caloric lateralization and directional preponderance on electro-oculography (EOG).
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2007.
- Background: PubMed 15269315Strupp 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.
- Background: PubMed 8470496Ohbayashi 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.
- Background: PubMed 2187486Ariyasu 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.
- Background: PubMed 10482275Arbusow 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.
- Background: PubMed 10728930Bergenius J, Perols O. Vestibular neuritis: a follow-up study. Acta Otolaryngol. 1999;119(8):895-9. doi: 10.1080/00016489950180243.
- Background: PubMed 12567089Shupak 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.
- Background: PubMed 10373697Cameron 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.
- Background: PubMed 11094095Fife 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Avi Shupak, MD principal investigator
Carmel Medical Center and Clalit Health Services, Haifa and West Galilee
Itzhak Braverman, MD principal investigator
Hillel Yaffe Medical Center
Avishai Golz, MD principal investigator
Rambam Health Care Campus
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Prednisone in people with Vestibular Diseases and Vestibular Neuronitis, run by Carmel Medical Center at 4 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical: The presence of static and dynamic nystagmus, positional and positioning nystagmus, and disequilibrium on bedside examination. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00271791, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2007.