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Leiden PREDMEN intratympanic methylprednisolone Meniere disease study

Also known as: Methylprednisolon, Methylprednisolone, PREDMEN, NCT05851508

Institution-led study

Primary source

Sponsor / Institution

Institution-led study

Program Type

Therapeutic

Modality

Steroid/Anti-inflammatory

Stage

Phase 3

Status

Active

Target Gene

—

Route / Mode

Intratympanic injection

Confidence

86%

Status Confidence

Status needs checking

Evidence Strength

Needs more support

Last Reviewed

2026-06-09

Geography

Netherlands

Population

adult, meniere-disease, tinnitus, hearing-loss

Trial IDs

Mechanism

Intratympanic methylprednisolone sodium succinate injections, 62.5 mg/mL, compared with placebo for control of vertigo attacks in Meniere disease, with hearing loss and tinnitus tracked as secondary outcomes.

Indications

Hearing Loss Tinnitus Meniere Disease

Notes

Corrected primary sponsor from Maastricht UMC to Leiden University Medical Center. The registry lists the PREDMEN trial as recruiting, Phase 3, and institution-led, with a 2024 BMJ Open protocol publication referenced by ClinicalTrials.gov.

Evidence & Sources

2 structured sources

clinicaltrials

Supports: canonicalName, aliases, allCompanies, isIndustrySponsored, stage, status, route, indications...

IDs: NCT05851508, PREDMEN

Open

publication

Supports: stage, mechanism, route, notes

IDs: PMID:39209781

Open

Key Events

2023-05-09