|- candidate number||22700|
|- NTR Number||NTR5379|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||11-aug-2015|
|- Secondary IDs||GELRE.ADC.BETMEN.2015. |
|- Public Title||The effect of a high dose compared to a low dose of betahistine in the treatment of vertigo attacks in Meničre's disease|
|- Scientific Title||A multicenter, double-blinded, randomised, 12 month, parallel group study to compare the efficacy of 48 mg BETahistine versus 8 [three times per day, tid] in the treatment of vertigo attacks in MENičre's disease.|
|- ACRONYM||BETMEN trial |
|- hypothesis||High dose betahistine (48 mg three times per day, tid) is superior to low dose betahistine (8 mg tid) in reducing the frequency of vertigo attacks in patients diagnosed with definite unilateral MD. |
|- Healt Condition(s) or Problem(s) studied||Meniere's disease, Betahistine|
|- 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.
3. ≥ 4 vertigo attacks over the last 6 months.
4. Willing to adhere to daily trial medication and the follow-up assessments.
|- 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.
3. Active additional neuro-otologic disorders that may mimic MD (e.g. vestibular migraine, recurrent vestibulopathy, phobic postural vertigo, vertebro-basilar TIAs, acoustic neuroma).
4. Otitis media with effusion or perforation of the eardrum based on tympanogram results.
5. Contraindication for usage of betahistine e.g. known pheochromocytoma, bronchial asthma or allergy to this agent.
6. History of intratympanic injections with corticosteroids, gentamicin or ear surgery for treating MD.
7. Use of other antihistaminic agents or MAO inhibitors.
8. Women of child bearing age not using contraception, pregnant women or nursing women.
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-dec-2016|
|- planned closingdate|
|- Target number of participants||74|
|- Interventions||Betahistine 48 mg three times per day or betahistine 8 mg three times per day. |
|- Primary outcome||Complete control of vertigo or reduction in vertigo attack frequence related to the dose of betahistine.
|- Secondary outcome||1.Frequency of co-interventions including: use of escape medication (metoclopramide) and intratympanic injections (dexamethason or gentamicin). |
2. Change in pure tone audiometry scores.
3. Change in Functional Level Scale scores.
4. Change in Dizziness Handicap Index scores.
5. Change in Tinnitus Handicap Index scores.
6. Change in Multifrequency Tympanometry scores (Y width).
7. Frequency of adverse events.
|- Trial web site||Not applicable |
|- CONTACT FOR PUBLIC QUERIES||MD, PhD Candidate Babette van Esch|
|- CONTACT for SCIENTIFIC QUERIES||MD, PhD Candidate Babette van Esch|
|- Sponsor/Initiator ||Prof. Dr. P.P.G. van Benthem|
(Source(s) of Monetary or Material Support)
|Dr. J.D.E. van Suijlen|
|- Publications||Not applicable|
|- Brief summary||The effect of betahistine on vertigo attacks in patients with Meniere’s Disease (MD) has been investigated in several placebo-controlled randomized cross-over and parallel designed trials. Generally the authors concluded betahistine reduced vertigo attack frequency. A Cochrane review investigating this matter stated that due to the lack of high quality studies its clinical efficacy remains inconclusive. However, recent publications claim the existence of a dose-related effect of betahistine which needs to be further elucidated. As betahistine is registered as the only long-term treatment for MD patients in the Netherlands, performing a placebo-controlled trial would be unethical. Therefore, performing a dose-finding study is essential to clarify if a high dose betahistine (48 mg three times per day, tid) is superior to low dose betahistine (8 mg tid) in reducing the frequency of vertigo attacks in patients diagnosed MD. |
|- Main changes (audit trail)|
|- RECORD||11-aug-2015 - 6-okt-2015|