Contact information
Type
Scientific
Contact name
Prof Michael Strupp
ORCID ID
Contact details
Klinikum Grosshadern
Abt. f. Neurologie
Marchioninistrasse 15
Munich
81377
Germany
+49 (0)89 7095 6678
michael.strupp@med.uni-muenchen.de
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Secondary identifying numbers
04T-617
Study information
Scientific title
Medical treatment of Meniere's disease with betahistine: a placebo-controlled, dose-finding 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.
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
Patient information sheet
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
Reason abandoned (if study stopped)
Eligibility
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 type(s)
Patient
Age group
Not Specified
Sex
Both
Target number of participants
186
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
Sponsor information
Organisation
University Hospital Grosshadern (Klinikum Grosshadern) (Germany) - Department of Neurology
Sponsor details
c/o Prof. Dr. Michael Strupp
Klinikum Grosshadern
Abt. f. Neurologie
Marchioninistrasse 15
Munich
81377
Germany
+49 (0)89 7095 6678
michael.strupp@med.uni-muenchen.de
Sponsor type
Hospital/treatment centre
Website
http://www.klinikum.uni-muenchen.de/de/www/index.php
ROR
Funders
Funder type
Government
Funder name
German Federal Ministry of Education and Research (Bundesministerium Fur Bildung und Forschung [BMBF]) (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) Intention to share
No
IPD sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 21/01/2016 | Yes | No |