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: 9.1 Level: LLT Classification co
Conditions
Interventions
Trade Name: Vasomotal 24mg
Product Name: Betahistin
Pharmaceutical Form: Tablet
INN or Proposed INN: betahistin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 24-
Sponsors
Klinikum Grosshadern
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Investigation of the effect of high-dose (3x48mg/d), low dose (2x24mg/d) betahistin and placebo on the number of vertigo attacks during the last 3 months of the 9-month treatment period.;Secondary Objective: Investigation of the effect of high-dose (3x48mg/d), low dose (2x24mg/d) betahistin and placebo on the number of vertigo attacks during the last 3 months of the total follow-up period; median duration of vertigo attacks, median severity of vertigo attacks during the last 3 months of the treatment period and the last 3 months of the total follow-up period; change of peripheral vestibular function, tinnitus intensity, effect of tinnitus on quality of life, subjective hearing loss, objective hearing loss – determined by acoustic evoked potentials, change of handicap / impairment due to vertigo or dizziness – assessed by the Dizziness Handicap Inventory (DHI) and the Vestibular Disorders Activities of Daily Living (VADL) score – between baseline, 9-month and 12-month follow-up visit.;Primary end point(s): Number of attacks in the three treatment arms during the last 3 months of the treatment period. | — |
Countries
Germany
Outcome results
None listed