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RECRUITING
NCT05851508
PHASE3

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

Sponsor: Leiden University Medical Center

View on ClinicalTrials.gov

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.

Official title: 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).

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

148

Start Date

2023-10-01

Completion Date

2027-02-01

Last Updated

2023-12-04

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

Methylprednisolon

Intratympanal injection with Methylprednisolon 62.5 mg/ ml

DRUG

Placebo

Intratympanal injection with saline, natriumchloride 0.9%

Locations (1)

Leiden University Medical Centre

Leiden, South Holland, Netherlands