Treatment of Ménière's disease with intratympanic methylprednisolone (PREDMEN trial)

Phase 1

Recruiting

• Conditions: Ménière's disease; MedDRA version: 20.1Level: PTClassification code: 10049934Term: Endolymphatic hydrops Class: 100000004854; MedDRA version: 21.1Level: LLTClassification code: 10081113Term: Otitis media with effusion Class: 10021881; MedDRA version: 20.0Level: PTClassification code: 10022086Term: Injection site pain Class: 100000004867; MedDRA version: 20.0Level: LLTClassification code: 10047339Term: Vertiginous syndromes and other disorders of vestibular system Class: 10013993; MedDRA version: 20.0Level: PTClassification code: 10045210Term: Tympanic membrane perforation Class: 100000004854; MedDRA version: 20.0Level: SOCClassification code: 10013993Term: Ear and labyrinth disorders Class: 10; MedDRA version: 20.1Level: LLTClassification code: 10019246Term: Hearing loss Class: 10013993; MedDRA version: 20.0Level: PTClassification code: 10033078Term: Otitis media Class: 100000004862; MedDRA version: 20.0Level: PTClassification code: 10013573Term: Dizziness Class: 100000004852

• Registration Number: CTIS2023-503340-13-00
• Lead Sponsor: eiden University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-06
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 148

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., Age > 18 years at the start of the trial., = 4 vertigo attacks over the last 6 months.

Exclusion Criteria

Bilateral Meniere's Disease., 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., Women of child bearing age not using contraception, pregnant women, nursing women.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified