Meniere's DiseasePhase 4NCT00831688
Efficacy of Local Overpressure Treatment for Meniere's Disease
A Phase 4 study testing Meniett(C) device by MedTronic in people with Meniere's Disease, run by Klinikum der Universitaet Muenchen, Grosshadern at 1 site in Germany.
Trial summary
The purpose of this study to date, is that no causal therapy for Meniere's disease has been discovered. Local overpressure treatment for Meniere's disease is a new treatment form that has been shown in animal and human experiments to reduce the endolymphatic hydrops, a condition that is generally believed to be the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meniere's Disease
- What is being tested?
- Meniett(C) device by MedTronic
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2005to Apr 2009
- Phase
- Phase 4
- 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
- unilateral definite Meniere's disease according to the AAO-HNS criteria
Who cannot join
- previous destructive treatment (gentamicin, saccotomy, vestibular neurectomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 3 Study of Efficacy of Local Overpressure Treatment for Meniere's Disease
The purpose of this study to date, is that no causal therapy for Meniere's disease has been discovered. Local overpressure treatment for Meniere's disease is a new treatment form that has been shown in animal and human experiments to reduce the endolymphatic hydrops, a condition that is generally believed to be the pathologic hallmark of Meniere's disease. This study analyzes the efficacy of local overpressure treatment by measuring subjective vertigo severity and objective audiovestibular function parameters.
Read the detailed description
Randomized double-blind controlled trial. Patients with unilateral Meniere's disease that suffer from recurring vertigo attacks are allocated to either a verum or a placebo device and are treated for 4 months. Before during and after the treatment period, subjective and objective audiovestibular function parameters are measured.
- Conditions
- Meniere's Disease
- Being tested
- Meniett(C) device by MedTronic, placebo treatment
- Keywords
- Meniere, vertigo, overpressure treatment, caloric irrigation, hearing levels, vertigo severity, functional disability scale
- Medical subject headings
- Meniere Disease, Vertigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meniett(C) device by MedTronicDevice
Also called Meniett
pulsed pressure application, up to 12 cm H20 column, 3 times daily for 5 minutes, generated by Meniett device and conducted to middle ear cavity via tympanostomy tube
placebo treatmentDevice
Also called Placebo
device seemingly identical to active device, manufactured by Medtronic. 3 times daily for 5 minutes.Produces similar sound effect, but without pulsed pressure elevation.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Local overpressure treatment Receives: Device: Meniett(C) device by MedTronic |
| 2 | Placebo comparator | Placebo treatment Receives: Device: placebo treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in vertigo score from pre-therapy to post-therapy. (Vertigo score = summation of daily vertigo severity over 4 weeks. Daily vertigo score = a number between = and 4.)
Measured: 4 months
Secondary outcomes (4)
Pure tone audiometric thresholds
Measured: 4 months
Speech recognition hearing levels
Measured: 4 months
Horizontal semicircular canal paresis
Measured: 4 Months
Subjective Daily Activity levels (Number between 0 and 4)
Measured: 4 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2009 (estimated)
- Study startAug 2005
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meniere's DiseaseStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Klinikum der Universitaet Muenchen, Grosshadern
- Sponsor type
- University, hospital or other
- Investigators
- Eike Krause, MD, Principal investigator, LMU Munich, Department of ENTRobert Gürkov, MD, Principal investigator, LMU Munich, Department of ENT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00831688
- Sponsor's protocol ID
- Meniere trial 037/05
- Status last verified
- Apr 2009
- First submitted
- 28 Jan 2009
- Last updated
- 21 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study of Efficacy of Local Overpressure Treatment for Meniere's Disease
- ClinicalTrials.gov ID
- NCT00831688
- Acronym / sponsor ID
- Meniere trial 037/05
- Conditions
- Meniere's Disease
- Keywords
- Meniere, vertigo, overpressure treatment, caloric irrigation, hearing levels, vertigo severity, functional disability scale
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Klinikum der Universitaet Muenchen, GrosshadernUniversity, hospital or other
- Study start
- Aug 2005
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 29 Jan 2009 (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 this study to date, is that no causal therapy for Meniere's disease has been discovered. Local overpressure treatment for Meniere's disease is a new treatment form that has been shown in animal and human experiments to reduce the endolymphatic hydrops, a condition that is generally believed to be the pathologic hallmark of Meniere's disease. This study analyzes the efficacy of local overpressure treatment by measuring subjective vertigo severity and objective audiovestibular function parameters.
Detailed description
Randomized double-blind controlled trial. Patients with unilateral Meniere's disease that suffer from recurring vertigo attacks are allocated to either a verum or a placebo device and are treated for 4 months. Before during and after the treatment period, subjective and objective audiovestibular function parameters are measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Meniett(C) device by MedTronicLocal overpressure treatment |
| 2 | Placebo comparator | Device: placebo treatmentPlacebo treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- unilateral definite Meniere's disease according to the AAO-HNS criteria
Key exclusion criteria (1 listed)
- previous destructive treatment (gentamicin, saccotomy, vestibular neurectomy
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 |
|---|---|---|
| Meniett(C) device by MedTronicAlso: Meniettpulsed pressure application, up to 12 cm H20 column, 3 times daily for 5 minutes, generated by Meniett device and conducted to middle ear cavity via tympanostomy tube | Device | 1 |
| placebo treatmentAlso: Placebodevice seemingly identical to active device, manufactured by Medtronic. 3 times daily for 5 minutes.Produces similar sound effect, but without pulsed pressure elevation. | Device | 2 |
Primary outcome
Change in vertigo score from pre-therapy to post-therapy. (Vertigo score = summation of daily vertigo severity over 4 weeks. Daily vertigo score = a number between = and 4.)
Time frame: 4 months
4 secondary outcomes
Pure tone audiometric thresholds
Time frame: 4 months
Speech recognition hearing levels
Time frame: 4 months
Horizontal semicircular canal paresis
Time frame: 4 Months
Subjective Daily Activity levels (Number between 0 and 4)
Time frame: 4 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 21 Apr 2009.
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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.
Eike Krause, MD principal investigator
LMU Munich, Department of ENT
Robert Gürkov, MD principal investigator
LMU Munich, Department of ENT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Meniett(C) device by MedTronic in people with Meniere's Disease, run by Klinikum der Universitaet Muenchen, Grosshadern at 1 site in Germany.
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 1 inclusion and 1 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 21 Apr 2009. 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 Germany. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Change in vertigo score from pre-therapy to post-therapy. (Vertigo score = summation of daily vertigo severity over 4 weeks. Daily vertigo score = a number between = and 4.) (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Apr 2009.