Condition category
Ear, Nose and Throat
Date applied
10/08/2007
Date assigned
12/09/2007
Last edited
25/01/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

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 number

ClinicalTrials.gov number

Protocol/serial number

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

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

Trial setting

Not specified

Trial 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

Phase

Not Specified

Drug names

Betahistin

Primary outcome measures

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 trial start date

01/11/2007

Overall trial end date

30/01/2012

Reason abandoned

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

Patient

Age group

Not Specified

Gender

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

Trial 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

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2016 results in http://www.ncbi.nlm.nih.gov/pubmed/26797774

Publication citations

Additional files

Editorial Notes