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

Not Applicable

Completed

Conditions: Meniere's disease
Ear, Nose and Throat
Disorder of the inner ear

Registration Number: ISRCTN44359668

Lead Sponsor: niversity Hospital Grosshadern (Klinikum Grosshadern) (Germany) - Department of Neurology

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 186

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of vertigo attacks in the three treatment arms during the last three months of the treatment period.

Secondary Outcome Measures

Name	Time	Method
1. Number of vertigo attacks during the last three months of the total follow-up period<br>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<br>3. Change of:<br>3.1. Peripheral vestibular function<br>3.2. Tinnitus intensity<br>3.3. Effect of tinnitus on quality of life<br>3.4. Subjective hearing loss<br>3.5. Objective hearing loss - determined by acoustic evoked potentials<br>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<br>Between baseline, nine-month and 12-month follow-up visit