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

NCT ID: NCT05851508

Last Updated: 2023-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2027-02-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Meniere Disease

Keywords

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Meniere's disease Methylprednisolon Intratimpanic corticosteroids Dizziness Hearing loss tinnitus aural fullness randomized control trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A multicenter, double-blinded, randomized, placebo-controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
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.

Study Groups

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Methylprednisolon

Intratympanal injection with Methylprednisolon 62.5 mg/ ml

Group Type ACTIVE_COMPARATOR

Methylprednisolon

Intervention Type DRUG

Intratympanal injection with Methylprednisolon 62.5 mg/ ml

Placebo

Intratympanal injection with saline, natriumchloride 0.9%

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Intratympanal injection with saline, natriumchloride 0.9%

Interventions

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Methylprednisolon

Intratympanal injection with Methylprednisolon 62.5 mg/ ml

Intervention Type DRUG

Placebo

Intratympanal injection with saline, natriumchloride 0.9%

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

Sponsor Role collaborator

Gelre Hospitals

OTHER

Sponsor Role collaborator

Maasstad Hospital

OTHER

Sponsor Role collaborator

Maastricht University Medical Center

OTHER

Sponsor Role collaborator

Medisch Spectrum Twente

OTHER

Sponsor Role collaborator

HagaZiekenhuis

OTHER

Sponsor Role collaborator

Leiden University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Babette F van Esch, MD, PhD

dr. van Esch, MD, PHD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Leiden University Medical Centre

Leiden, South Holland, Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Maud Boreel, MD

Role: CONTACT

Phone: +3171 526 9111

Email: [email protected]

Babette van Esch, MD, PHD

Role: CONTACT

Phone: +3171 526 9111

Email: [email protected]

Facility Contacts

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Maud Boreel, Msc

Role: primary

References

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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.

Reference Type DERIVED
PMID: 39209781 (View on PubMed)

Other Identifiers

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10140022110009

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PREDMEN

Identifier Type: -

Identifier Source: org_study_id