Meniere's disease Ear, Nose and Throat Disorder of the inner ear
Conditions
Interventions
Please note that the first patient was randomised in April 2008.
The trial comprises three arms:
1. Therapy with high-dose betahistine (3 x 48 mg)
2. Therapy with low-dose betahistine (2 x 24 mg)
3
Sponsors
University Hospital Grosshadern (Klinikum Grosshadern) (Germany) - Department of Neurology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Definite Meniere's disease according to the American Academy of Ophthalmology and Otolaryngology, Head and Neck Surgery: 1.1. Two or more attacks of vertigo, each lasting more than 20 minutes 1.2. Audiometrically documented hearing loss in at least one examination 1.3. Tinnitus or aural fullness in the affected ear 1.4. Other causes excluded 2. At least two attacks of Meniere's disease per month for at least three subsequent months 3. Aged 18 to 80 years 4. Written informed consent to all protocol-specified procedures
Exclusion criteria
Exclusion criteria: 1. Other vestibular disorders such as vestibular migraine or phobic postural vertigo 2. Contraindications for treatment with betahistine-dihydrochloride, such as: 2.1. Asthma bronchiale 2.2. Pheochromacytoma 2.3. Pregnancy or breast-feeding 2.4. Severe dysfunction of kidneys or liver 2.5. Ulcer of the stomach or duodenum 2.6. Tumours 2.7. Severe coronary heart disease 2.8. Treatment with other antihistamines
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of vertigo attacks in the three treatment arms during the last three months of the treatment period. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of vertigo attacks during the last three months of the total follow-up period 2. Median duration of vertigo attacks and median severity of vertigo attacks during the last three months of the treatment period and the last three months of the total follow-up period 3. Change of: 3.1. Peripheral vestibular function 3.2. Tinnitus intensity 3.3. Effect of tinnitus on quality of life 3.4. Subjective hearing loss 3.5. Objective hearing loss - determined by acoustic evoked potentials 3.6. 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, nine-month and 12-month follow-up visit | — |
Countries
Germany
Outcome results
None listed