Medical treatment of Meniere's disease with betahistine: a placebo-controlled, dose-finding study
| ISRCTN | ISRCTN44359668 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44359668 |
| Secondary identifying numbers | 04T-617 |
- Submission date
- 10/08/2007
- Registration date
- 12/09/2007
- Last edited
- 25/01/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Ear, Nose and Throat
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Prof Michael Strupp
Scientific
Scientific
Klinikum Grosshadern
Abt. f. Neurologie
Marchioninistrasse 15
Munich
81377
Germany
| Phone | +49 (0)89 7095 6678 |
|---|---|
| michael.strupp@med.uni-muenchen.de |
Study information
| Study design | Placebo-controlled, double-blind, randomised controlled trial. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | Medical treatment of Meniere's disease with betahistine: a placebo-controlled, dose-finding study |
| Study acronym | BEMED |
| 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. As of 20/12/2011, target number of participants and anticipated end date have been modified. Previous target number of participants: 84 Previous anticipated end date: 31/10/2010 |
| Ethics approval(s) | Ethics approval received from the local medical ethics board on the 2nd February 2008. |
| Condition | Meniere's disease |
| Intervention | 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). |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Betahistin |
| Primary outcome measure | Number of vertigo attacks in the three treatment arms during the last three months of the treatment period. |
| Secondary outcome measures | 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 |
| Overall study start date | 01/11/2007 |
| Overall study end date | 30/01/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | 186 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 01/11/2007 |
| Recruitment end date | 30/01/2012 |
Locations
Countries of recruitment
- Germany
Study participating centre
Klinikum Grosshadern
Munich
81377
Germany
81377
Germany
Sponsor information
University Hospital Grosshadern (Klinikum Grosshadern) (Germany) - Department of Neurology
Hospital/treatment centre
Hospital/treatment centre
c/o Prof. Dr. Michael Strupp
Klinikum Grosshadern
Abt. f. Neurologie
Marchioninistrasse 15
Munich
81377
Germany
| Phone | +49 (0)89 7095 6678 |
|---|---|
| michael.strupp@med.uni-muenchen.de | |
| Website | http://www.klinikum.uni-muenchen.de/de/www/index.php |
"ROR" |
https://ror.org/02jet3w32 |
Funders
Funder type
Government
German Federal Ministry of Education and Research (Bundesministerium Fur Bildung und Forschung [BMBF]) (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 21/01/2016 | Yes | No |
