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

NCT05851508 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 148

Last updated 2023-12-04

No results posted yet for this study

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.

Conditions

  • Meniere Disease

Interventions

DRUG

Methylprednisolon

Intratympanal injection with Methylprednisolon 62.5 mg/ ml

DRUG

Placebo

Intratympanal injection with saline, natriumchloride 0.9%

Sponsors & Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER

  • Gelre Hospitals

    collaborator OTHER

  • Maasstad Hospital

    collaborator OTHER

  • Maastricht University Medical Center

    collaborator OTHER

  • Medisch Spectrum Twente

    collaborator OTHER

  • HagaZiekenhuis

    collaborator OTHER

  • Leiden University Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-01
Primary Completion
2026-05-01
Completion
2027-02-01

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05851508 on ClinicalTrials.gov