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02 September 2010
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| [ Print-friendly version ] |
| Medical treatment of Meniere's disease with betahistine: a placebo-controlled, dose-finding study |
| ISRCTN | ISRCTN44359668 |
| ClinicalTrials.gov identifier | |
| Public title | Medical treatment of Meniere's disease with betahistine: a placebo-controlled, dose-finding study |
| Scientific title | |
| Acronym | BEMED |
| Serial number at source | 04T-617 |
| Study hypothesis | High-dose betahistin (3 x 48 mg per day) is more effective in reducing the number of vertigo attacks in Meniere's disease than low-dose betahistin (3 x 24 mg) or placebo. |
| Ethics approval | Ethics approval received from the local medical ethics board on the 2nd February 2008. |
| Study design | Placebo-controlled, double-blind, randomised controlled trial. |
| Countries of recruitment | Germany |
| Disease/condition/study domain | Meniere's disease |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/11/2007 |
| Anticipated end date | 31/10/2010 |
| Status of trial | Ongoing |
| Patient information material | |
| Target number of participants | 84 |
| 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. Placebo The total treatment time will be nine months with a three month follow-up. The trial is estimated to last three years (first patient in to last patient out). |
| Primary outcome measure(s) | Number of vertigo attacks in the three treatment arms during the last three months of the treatment period. |
| Secondary outcome measure(s) |
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 |
| Sources of funding | German Federal Ministry of Education and Research (Bundesministerium Fur Bildung und Forschung [BMBF]) (Germany) |
| Trial website | |
| Publications | |
| Contact name | Prof Michael Strupp |
| Address |
Klinikum Grosshadern
Abt. f. Neurologie Marchioninistrasse 15 |
| City/town | Munich |
| Zip/Postcode | 81377 |
| Country | Germany |
| Tel | +49 (0)89 7095 6678 |
| Fax | +49 (0)89 7095 6673 |
| michael.strupp@med.uni-muenchen.de | |
| Sponsor | University Hospital Grosshadern (Klinikum Grosshadern) (Germany) - Department of Neurology |
| Address |
c/o Prof. Dr. Michael Strupp
Klinikum Grosshadern Abt. f. Neurologie Marchioninistrasse 15 |
| City/town | Munich |
| Zip/Postcode | 81377 |
| Country | Germany |
| Tel | +49 (0)89 7095 6678 |
| Fax | +49 (0)89 7095 6673 |
| michael.strupp@med.uni-muenchen.de | |
| Sponsor website: | http://www.klinikum.uni-muenchen.de/de/www/index.php |
| Date applied | 10/08/2007 |
| Last edited | 29/04/2008 |
| Date ISRCTN assigned | 12/09/2007 |
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