A Phase 3 interventional study of Methylprednisolon and Placebo in Meniere Disease, sponsored by Leiden University Medical Center. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-04.
Sponsored by Leiden University Medical Center · Phase 3, Interventional, and Treatment
Ménière's disease is an inner ear disorder in which patients suffer from attacks of vertigo, tinnitus and hearing loss. To date, it is unclear what the best treatment for this condition is. Giving injections in the inner ear with the adrenal cortical hormone methylprednisolone is a treatment that is already widely used, but still there is insufficient evidence in the effectiveness of this treatment. This multicenter trial compares a patient group which receives injections of methylprednisolone to a patient group which receives placebo injections. Subsequently, dizziness, tinnitus, hearing loss and quality of life will be assed and compared for the above mentioned groups, over a period of one year.
Meniere's disease is an inner ear disease characterized by recurrent episodes of vertigo, hearing loss, tinnitus and aural fullness. It is estimated that 15000 patients in de Netherlands suffer from this disease. Endolymfactic hydrops is thought to be the underlying pathophysiology of the symptoms. Salt restriction, oral medication (diuretics and betahistine), intratympanic gentamicin and steroids, ablative surgery, and endolymphatic sac surgery are some of the current therapy options. A probable effectiveness of the treatment with intratympanic gentamicin is found but this treatment is ototoxic and carries a risk of hearing loss. Methylprednisolone injections have been shown to be safer, however there is insufficient data to support the efficacy of this treatment. Therefore in this double-blinded, randomized, placebo-controlled trial, effectiveness of intratympanic injections with methylPREDnisolon versus placebo in the treatment of vertigo attacks in MENière's disease is compared.
The investigators aim to include 74 patients in each arm, based on a statistical power of 80 percent. Patients will be randomly randomized to one of the two treatment arms, receiving either a placebo injection or a methylprednisolone sodium succinate injection at a dose of 62.5 mg/ml. After 14 days, this injection will be given once more. A follow-up visit will be scheduled after six and twelve months and telephone follow-up calls will be scheduled after three and nine months. The primary objective will be the control of vertigo, with secondary outcomes including hearing loss, tinnitus, the frequency of escape interventions, quality of life, adverse events and cost effectiveness.
74 studies on the registry are indexed under Meniere Disease; 12 are open to participants now.
This study's planned enrollment of 148 is above the median of 44 across 61 interventional studies indexed under Meniere Disease.
Browse Meniere Disease studies →Leiden University Medical Center is the lead sponsor of 334 studies on the registry; 110 are open to participants now.
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Definite MD Two or more spontaneous episodes of vertigo, each lasting 20 minutes to 12 hours, AND Audiometrically documented low- to medium-frequency sensorineural hearing loss in one ear, defining the affected ear on at least one occasion before, during or after one of the episodes of vertigo, AND Fluctuating aural symptoms (hearing, tinnitus, or fullness) in affected ear (not better accounted for by another vestibular diagnosis)
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intratympanal injection with Methylprednisolon 62.5 mg/ ml
Drug: Methylprednisolon
Intratympanal injection with saline, natriumchloride 0.9%
Drug: Placebo
Intratympanal injection with Methylprednisolon 62.5 mg/ ml
Intratympanal injection with saline, natriumchloride 0.9%
Vertigo spells
A definitive vertigo spell is defined as a spontaneous rotational vertigo symptom, which lasts at least 20 minutes and is often accompanied by disequilibrium and vomiting. No loss of consciousness is present. Vertigo spells are measured daily with the dizzy quest ap. Futhermore, at baseline after 6 and 12 months, caloric testing and a video-head impusle test are performend. Additionally the dizziness handicap inventory will be taken.
Time frame: Daily, change from baseline to one year
Hearing loss
Hearing loss will be measured at baseline, 6 and 12 months after injection. Pure tone audimetry and extended fletcher index including the speech discrimination score will be tested.
Time frame: At baseline, 6 months and 12 months
Tinnitus
Tinnitus will be measured with the tinnitus handicap inventory at baseline, after 6 and 12 months.
Time frame: At baseline, 6 months and 12 months
health-related quality of life
The health realted quality of life will be evaluated with the generic quality of life questionnaire: EQ-5D
Time frame: At baseline, 6 months and 12 months
health-related quality of life
The health realted quality of life will be evaluated with the generic quality of life questionnaire: EQ-VAS, this will be a scale from 0 to 100 in which 0 means the worst health you can imagine and 100 means the best health you can imagine
Time frame: At baseline, 6 months and 12 months
Escape medication
The frequency of use of metoclopramide in the acute phase of vertigo will be registered.
Time frame: At baseline, 3 months, 6 months, 9 months, 12 months
Adverse events
At each study visit, subjects will be questioned about adverse events they have experienced since the last study visit.
Time frame: Daily, change from baseline to one year
Cost-effectiveness
Costs per QALY, this will be calculated from above mentioned outcomes on quality of life.
Time frame: At baseline, 6 months and 12 months
Co-interventions
The use of additional methylprednisolon or gentamicine will be evaluated during the entire study.
Time frame: Daily, change from baseline to one year
Overall function
The functional level scale will be measured with the questionnaire: Functional level scale: a scale from 1-6 in which 1 means: my dizziness has no effect on my activities and 6 means: I have been disabled for one year or longer and/or I received compensation (money) because of y dizziness or balance problem.
Time frame: At baseline, 6 months and 12 months
Impact of Dizziness
The impact of dizziness will be measured with the questionnaire: Dizziness handicap inventory
Time frame: Change from baseline to 6 months to 12 months
Tinnitus severity
The tinnitus severety will be measured with the questionnaire: Tinnitus functional index
Time frame: At baseline, 6 months and 12 months
Plan to share: Yes — Individual patient data after deidentification will be shared upon reasonable request with researchers who provide a methodologically sound proposal. For analyses to achieve aims as described in the approved proposal.
Supporting information: Study protocol, Informed consent form, Analytic code
Time frame: Data will be accessible after publication of the data
Access criteria: Data can be shared upon reasonable request for multiple purposes. Proposals should be directed to M.M.E.Boreel@lumc.nl. To share data we will use the data transfer agreement in line with the template provided by the LUMC
No publications or documents are linked to this record.
Started Oct 2023 (actual). Primary completion is estimated for May 2026, 31 months after the start.
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Studies of the drug tested here: Methylprednisolone
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