Vestibular NeuritisEarly Phase 1NCT01231009
The Role of Corticosteroids and Vestibular Exercises in Recovery of Vestibular Neuritis
A Early Phase 1 study testing Corticosteroids and Vestibular exercises in people with Vestibular Neuritis, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
Aim of present study is to determine whether corticosteroids and vestibular exercises are equal effective in the recovery of balance in patients with acute vestibular neuritis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Vestibular Neuritis
- What is being tested?
- Corticosteroids and Vestibular exercises
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteGreece
- Study dates
- Jan 2010to Jan 2013
- Phase
- Early Phase 1
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with history of acute or sub-acute rotatory vertigo with postural imbalance, nausea and imbalance.
- Horizontal-rotatory spontaneous nystagmus.
Who cannot join
- History of vestibular disfunction before the acute onset of symptoms
- Simultaneous Hearing loss
- Neurologic disorder
- Pregnancy or lactation
- History of psychiatric disorders
- History of glaucoma
Show all 9Show fewer
- Diabetes
- Hypertension
- Contraindication in receiving corticosteroids
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
1st ENT Department, AHEPA University Hospital
Thessaloniki, 54636
John Goudakos, MD, MSc
Konstantinos Markou, MD, PhD
About this study
Official title: The Role of Corticosteroids and Vestibular Exercises in Recovery of Vestibular Neuritis: a Prospective Randomized Controlled Clinical Trial
Aim of present study is to determine whether corticosteroids and vestibular exercises are equal effective in the recovery of balance in patients with acute vestibular neuritis.
- Conditions
- Vestibular Neuritis
- Being tested
- Corticosteroids, Vestibular exercises
- Medical subject headings
- Vestibular Neuronitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CorticosteroidsDrug
Intravenous Dexamethasone, 8mg three times per day tapering down for 7 days Per os dexamethasone, 2mg per day tapering down for 7 days
Vestibular exercisesOther
Vestibular exercises in order to enhance vestibulo-ocular reflex for 15 days under the suspicion of physiotherapist
| Study group | Role | What they receive |
|---|---|---|
| Corticosteroids | Active comparator | Patients receive for 7 days intravenous corticosteroids, dexamethasone, and they continue receiving for 7 days corticosteroids per os Receives: Drug: Corticosteroids; Other: Vestibular exercises |
| Vestibular exercises | Placebo comparator | Patients perform for 15 days certain vestibular exercises under suspicion of an expert physiotherapist Receives: Drug: Corticosteroids; Other: Vestibular exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical recovery of vestibular function
clinical examination (nystagmus, Romberg test, head-thrust test, head-shaking test) and questionnaires (Greek edition of Dizziness Handicap Inventory and European Evaluation of Vertigo Scale)
Measured: 1 year
Laboratory recovery of vestibular
caloric test and vestibular evoked myogenic potentials
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2010 (estimated)
- Study startJan 2010
- Primary completionJan 2012 (estimated)
- Study completionJan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vestibular NeuritisStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01231009
- Sponsor's protocol ID
- VN-01-JG
- Status last verified
- Jan 2010
- First submitted
- 29 Oct 2010
- Last updated
- 1 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Goudakos JK, Markou KD, Psillas G, Vital V, Tsaligopoulos M. Corticosteroids and vestibular exercises in vestibular neuritis. Single-blind randomized clinical trial. JAMA Otolaryngol Head Neck Surg. 2014 May;140(5):434-40. doi: 10.1001/jamaoto.2014.48.
PubMed 24604142
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Corticosteroids and Vestibular Exercises in Recovery of Vestibular Neuritis: a Prospective Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT01231009
- Acronym / sponsor ID
- VN-01-JG
- Conditions
- Vestibular Neuritis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Jan 2013 (estimated)
- First posted
- 1 Nov 2010 (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.
Aim of present study is to determine whether corticosteroids and vestibular exercises are equal effective in the recovery of balance in patients with acute vestibular neuritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Corticosteroids | Active comparator | Drug: Corticosteroids, Other: Vestibular exercisesPatients receive for 7 days intravenous corticosteroids, dexamethasone, and they continue receiving for 7 days corticosteroids per os |
| Vestibular exercises | Placebo comparator | Drug: Corticosteroids, Other: Vestibular exercisesPatients perform for 15 days certain vestibular exercises under suspicion of an expert physiotherapist |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with history of acute or sub-acute rotatory vertigo with postural imbalance, nausea and imbalance.
- Horizontal-rotatory spontaneous nystagmus.
Key exclusion criteria (9 listed)
- History of vestibular disfunction before the acute onset of symptoms
- Simultaneous Hearing loss
- Neurologic disorder
- Pregnancy or lactation
- History of psychiatric disorders
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 |
|---|---|---|
| CorticosteroidsIntravenous Dexamethasone, 8mg three times per day tapering down for 7 days Per os dexamethasone, 2mg per day tapering down for 7 days | Drug | Corticosteroids, Vestibular exercises |
| Vestibular exercisesVestibular exercises in order to enhance vestibulo-ocular reflex for 15 days under the suspicion of physiotherapist | Other | Corticosteroids, Vestibular exercises |
Primary outcome
clinical recovery of vestibular function
Time frame: 1 year
clinical examination (nystagmus, Romberg test, head-thrust test, head-shaking test) and questionnaires (Greek edition of Dizziness Handicap Inventory and European Evaluation of Vertigo Scale)
Laboratory recovery of vestibular
Time frame: 1 year
caloric test and vestibular evoked myogenic potentials
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2010.
- Derived from this study: PubMed 24604142Goudakos JK, Markou KD, Psillas G, Vital V, Tsaligopoulos M. Corticosteroids and vestibular exercises in vestibular neuritis. Single-blind randomized clinical trial. JAMA Otolaryngol Head Neck Surg. 2014 May;140(5):434-40. doi: 10.1001/jamaoto.2014.48.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Corticosteroids and Vestibular exercises in people with Vestibular Neuritis, run by Aristotle University Of Thessaloniki at 1 site in Greece.
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 9 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: status not confirmed, as of the sponsor's last update on 1 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact John Goudakos, MD, MSc (00306944183682, jgoudakos@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical recovery of vestibular function (time frame: 1 year). The study lists 2 primary outcomes in all. 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 NCT01231009, which also lists 1 linked publication.
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 1 Nov 2010.