Medical treatment of Menière’s disease with betahistine:a placebo-controlled, dose-finding study

Active, not recruiting

Conditions: Ménière’s disease is a disorder of the inner ear membranous labyrinth characterized by paroxysmal vertiginous attacks, fluctuating sensorineural hearing loss, aural fullness, and tinnitus .The underlying pathophysiology of Ménière’s disease is commonly seen in a hydrops of the endolymphatic space of the membranous labyrinth, resulting in recurrent ruptures of the endolymphatic sac and spillage of potassium-rich fluid into the perilymphatic space.
MedDRA version: 9.1Level: LLTClassification code 10027183Term: Meniere's disease

Registration Number: EUCTR2005-000752-32-DE

Lead Sponsor: Klinikum Grosshadern

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Definite Ménière’s disease according to the American Academy of Ophthalmology and Otolaryngology, Head and Neck Surgery: Two or more attacks of vertigo, each lasting more than 20 minutes; audiometrically documented hearing loss in at least one examination;tinnitus or aural fullness in the affected ear; other causes excluded.
Further: at least two attacks of Ménière’s disease per month for at least 3 subsequent months. Age: 18 to 80 yrs; written informed consent to all protocol-specified procedures.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Other vestibular disorders such as vestibular migraine or phobic postural vertigo; contraindications for treatment with betahistine-dihydrochloride, such as asthma bronchiale, pheochromacytoma, pregnancy or breast-feeding, severe dysfunction of kidneys or liver, ulcer of the stomach or duodenum, tumors, severe coronary heart disease, treatment with other antihistamines.