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

ISRCTN	ISRCTN44359668
DOI	https://doi.org/10.1186/ISRCTN44359668
Protocol serial number	04T-617
Sponsor	University Hospital Grosshadern (Klinikum Grosshadern) (Germany) - Department of Neurology
Funder	German Federal Ministry of Education and Research (Bundesministerium Fur Bildung und Forschung [BMBF]) (Germany)

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 of protocol

Not provided at time of registration

Contact information

Prof Michael Strupp
Scientific

Klinikum Grosshadern
Abt. f. Neurologie
Marchioninistrasse 15
Munich
81377
Germany

Phone	+49 (0)89 7095 6678
Email	michael.strupp@med.uni-muenchen.de

Study information

Primary study design	Interventional
Study design	Placebo-controlled, double-blind, randomised controlled trial.
Secondary study design	Randomised controlled trial
Scientific title	Medical treatment of Meniere's disease with betahistine: a placebo-controlled, dose-finding study
Study acronym	BEMED
Study objectives	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.
Health condition(s) or problem(s) studied	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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Betahistin
Primary outcome measure(s)	Number of vertigo attacks in the three treatment arms during the last three months of the treatment period.
Key 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
Completion date	30/01/2012

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	All
Target sample size at registration	186
Key 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
Key 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
Date of first enrolment	01/11/2007
Date of final enrolment	30/01/2012

Locations

Countries of recruitment

Germany

Study participating centre

Klinikum Grosshadern

Munich
81377
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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