The effect of a high dose compared to a low dose of betahistine in the treatment of vertigo attacks in Menière's disease
- Conditions
- Menière's disease, betahistine, randomised controlled trial
- Registration Number
- NL-OMON27414
- Lead Sponsor
- Prof. Dr. P.P.G. van Benthem (November 2015)Functie/ Position: Hoogleraar Keel-, neus-, oorheelkunde │Opleiding/Education: Studierichting/ Subject:T: +31 55 844 8207 │ F: +31 55 581 8194 │E: p.van.benthem@gelre.nl Prof. Dr. P.P.G. van Benthem (november 2015)University Medical Centre LeidenHead Otorhinolaryngolgy and Head- and Neck Surgery P.O. Box 96002300 RC Leiden
- Brief Summary
ot applicable
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 74
Inclusion Criteria
1. Unilateral MD (definite or probable) according to diagnostic criteria derived from the American Academy Otolaryngology Head and Neck Surgery, Classification Committee of the Bárány Society, European Academy of Otology and Neurotology and International Classification of Vestibular Disorders published in 2015.
2. Age > 18 years at the start of the trial.
Exclusion Criteria
1.Bilateral MD.
2.Severe disability (e.g. neurological, orthopedic, cardiovascular) or serious concurrent illness that might interfere with treatment or follow-up.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Complete control of vertigo or reduction in vertigo attack frequence related to the dose of betahistine. <br>
- Secondary Outcome Measures
Name Time Method 1.Frequency of co-interventions including: use of escape medication (metoclopramide) and intratympanic injections (dexamethason or gentamicin). <br /><br>2. Change in pure tone audiometry scores. <br /><br>3. Change in Functional Level Scale scores.<br /><br>4. Change in Dizziness Handicap Index scores.<br /><br>5. Change in Tinnitus Handicap Index scores.<br /><br>6. Change in Multifrequency Tympanometry scores (Y width).<br /> <br>7. Frequency of adverse events.