The Effecttiveness of Intratympanic Methylprednisolon Injections Compared to Placebo in the Treatment of Vertigo Attacks in Meniere's Disease
PREDMEN
A 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).
2 other identifiers
interventional
148
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2023
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 20, 2023
CompletedFirst Posted
Study publicly available on registry
May 9, 2023
CompletedStudy Start
First participant enrolled
October 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2027
ExpectedDecember 4, 2023
November 1, 2023
2.6 years
February 20, 2023
November 28, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
Daily, change from baseline to one year
Secondary Outcomes (11)
Hearing loss
At baseline, 6 months and 12 months
Tinnitus
At baseline, 6 months and 12 months
health-related quality of life
At baseline, 6 months and 12 months
health-related quality of life
At baseline, 6 months and 12 months
Escape medication
At baseline, 3 months, 6 months, 9 months, 12 months
- +6 more secondary outcomes
Study Arms (2)
Methylprednisolon
ACTIVE COMPARATORIntratympanal injection with Methylprednisolon 62.5 mg/ ml
Placebo
PLACEBO COMPARATORIntratympanal injection with saline, natriumchloride 0.9%
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Leiden University Medical Centerlead
- ZonMw: The Netherlands Organisation for Health Research and Developmentcollaborator
- Gelre Hospitalscollaborator
- Maasstad Hospitalcollaborator
- Maastricht University Medical Centercollaborator
- Medisch Spectrum Twentecollaborator
- HagaZiekenhuiscollaborator
Study Sites (1)
Leiden University Medical Centre
Leiden, South Holland, 2300RC, Netherlands
Related Publications (1)
Boreel MME, van Esch B, Schermer TR, Mol BM, van Benthem PP, Bruintjes TD. The effectiveness of intratympanic injections with methylPREDnisolon versus placebo in the treatment of vertigo attacks in MENiere's disease (PREDMEN trial): a study protocol for a phase-3 multicentre, double-blinded, randomised, placebo-controlled trial. BMJ Open. 2024 Aug 29;14(8):e076872. doi: 10.1136/bmjopen-2023-076872.
PMID: 39209781DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Trial subjects, treating physicians and outcome assessors will be blinded throughout the entire study. Pharmacy staff will be unblinded for randomization and treatment allocation. Emergency unblinding may occur in the following situations: in case of a medical emergency where knowledge of the blinded treatment is necessary, for the treatment of (serious) adverse event, in the event of a SUSAR (Suspected Unexpected Serious Adverse Reaction) needing expedited reporting or if requested by the Safety Committee.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- dr. van Esch, MD, PHD
Study Record Dates
First Submitted
February 20, 2023
First Posted
May 9, 2023
Study Start
October 1, 2023
Primary Completion
May 1, 2026
Study Completion (Estimated)
February 1, 2027
Last Updated
December 4, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF, 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
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.