The Effecttiveness of Intratympanic Methylprednisolon Injections Compared to Placebo in the Treatment of Vertigo Attacks in Meniere's Disease

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified October 2023 by Leiden University Medical Center
Sponsor
Leiden University Medical Center
Information Provided by (Responsible Party)
Babette F van Esch, MD, PhD
Clinicaltrials.gov Identifier
NCT05851508
Other Study ID Numbers:
PREDMEN
First Submitted
February 19, 2023
First Posted
May 8, 2023
Last Update Posted
December 3, 2023
Last Verified
October 2023

ClinicalTrials.gov processed this data on November 2023. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

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.

Condition or DiseaseIntervention/Treatment
Meniere Disease
Drug: MethylprednisolonDrug: Placebo

Study Design

Study TypeInterventional
Actual Enrollment148 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposeTreatment
Official TitleA Multicenter, Double-blinded, Randomized, Placebo-controlled Trial to Compare the Effectiveness of Intratympanic Injections methylPREDnisolon Versus Placebo in the Treatment of Vertigo Attacks in MENière's Disease (PREDMEN Trial).
Study Start DateSeptember 30, 2023
Actual Primary Completion DateApril 30, 2026
Actual Study Completion Date8mos 2w from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Methylprednisolon
Intratympanal injection with Methylprednisolon 62.5 mg/ ml
Drug: Methylprednisolon
Intratympanal injection with Methylprednisolon 62.5 mg/ ml
Placebo
Intratympanal injection with saline, natriumchloride 0.9%
Drug: Placebo
Intratympanal injection with saline, natriumchloride 0.9%

Outcome Measures

Primary Outcome Measures
  1. 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.
Secondary Outcome Measures
  1. 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.
  2. Tinnitus
    Tinnitus will be measured with the tinnitus handicap inventory at baseline, after 6 and 12 months.
  3. health-related quality of life
    The health realted quality of life will be evaluated with the generic quality of life questionnaire: EQ-5D
  4. 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
  5. Escape medication
    The frequency of use of metoclopramide in the acute phase of vertigo will be registered.
  6. Adverse events
    At each study visit, subjects will be questioned about adverse events they have experienced since the last study visit.
  7. Cost-effectiveness
    Costs per QALY, this will be calculated from above mentioned outcomes on quality of life.
  8. Co-interventions
    The use of additional methylprednisolon or gentamicine will be evaluated during the entire study.
  9. 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.
  10. Impact of Dizziness
    The impact of dizziness will be measured with the questionnaire: Dizziness handicap inventory
  11. Tinnitus severity
    The tinnitus severety will be measured with the questionnaire: Tinnitus functional index

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersYes
Inclusion Criteria
Inclusion criteria: • Unilateral, definite MD according to the diagnostic criteria derived from the American Academy Otolaryngology Head and Neck Surgery, Classification Committee of the Bárány Society, European Academy of Otology and Neurotology and International Classification of Vestibular Disorders published in 2015 \[7\] (see Appendix 1): 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)
age \> 18 years at the start of the trial.
≥ 4 vertigo attacks over the last 6 months.
willing to adhere to daily trial medications and the follow-up assessments.
Exclusion Criteria
Inclusion criteria: • Unilateral, definite MD according to the diagnostic criteria derived from the American Academy Otolaryngology Head and Neck Surgery, Classification Committee of the Bárány Society, European Academy of Otology and Neurotology and International Classification of Vestibular Disorders published in 2015 \[7\] (see Appendix 1): 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)
age \> 18 years at the start of the trial.
≥ 4 vertigo attacks over the last 6 months.
willing to adhere to daily trial medications and the follow-up assessments. Exclusion criteria A potential subject who meets any of the following criteria will be excluded:
bilateral MD
severe disability (e.g. neurological, orthopaedic, cardiovascular) or serious concurrent illness that might interfere with treatment or follow-up.
active additional neuro-otologic disorders that may mimic MD (e.g. vestibular migraine, recurrent vestibulopathy, phobic postural vertigo, vertebro-basilar TIAs, acoustic neuroma).
otitis media with effusion based on tympanogram results.
history of intratympanic injections with corticosteroid less than 6 months ago.
history of intratympanic injections with gentamicin or ear surgery for treating MD.
pregnant women and nursing women.

Contacts and Locations

Sponsors and CollaboratorsLeiden University Medical Center
Locations
Leiden University Medical Centre | Leiden South Holland, Netherlands, 2300RC