NCT05851508 The Effecttiveness of Intratympanic Methylprednisolon Injections Compared to Placebo in the Treatment of Vertigo Attacks in Meniere's Disease
| NCT ID | NCT05851508 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Leiden University Medical Center |
| Condition | Meniere Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 148 participants |
| Start Date | 2023-10-01 |
| Primary Completion | 2026-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 148 participants in total. It began in 2023-10-01 with a primary completion date of 2026-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05851508 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Meniere Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05851508 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 148 participants.
Is NCT05851508 currently recruiting?
Yes, NCT05851508 is actively recruiting participants. Contact the research team at m.m.e.boreel@lumc.nl for enrollment information.
Where is the NCT05851508 trial being conducted?
This trial is being conducted at Leiden, Netherlands.
Who is sponsoring the NCT05851508 clinical trial?
NCT05851508 is sponsored by Leiden University Medical Center. The trial plans to enroll 148 participants.