This is a randomized, double-blind, double-dummy, parallel-group, international, multicenter study to compare the effect of the investigational drug in the formulation of orodispersible tablets and tablets on vertigo attacks in subjects with Ménière’s disease or vestibular vertigo.
The clinical trial is planned to take place in Russia and Ukraine. In Ukraine, the local ethics committees have reviewed the application package in parallel with the ministry of health. Now the import license is being applied for and the study drug is being prepared for the import into the country. In two weeks OCT will start sites initiation in the Ukrainian medical centers. As for Russia, the Ministry of healthcare took longer to review the submission package. Twelve sites are planned to be involved in Russia and eight sites will be included in Ukraine. The total number of 20 investigational sites will be recruiting the target number of 120 patients to be allocated to treatment within the planned enrollment period of 8 months. For this aim, up to 200 subjects will be screened according to the inclusion and exclusion criteria.
The primary objective of this study is to demonstrate non-inferiority of 12 weeks treatment with the investigational product in the formulation of orodispersible tablets (ODT) to 12 weeks treatment with the formulation of tablets, with regard to the total number of vertigo attacks in subjects with Ménière’s disease or vestibular vertigo.
The secondary objective is to compare the duration and the severity of vertigo attacks and subjects’ well-being.
Ménière’s disease is a chronic, incurable vestibular disorder which produces a recurring set of symptoms as a result of abnormally large amounts of a fluid called endolymph collecting in the inner ear.
Ménière’s disease can develop at any age, but it is more likely to happen to adults between 40 and 60 years of age. The exact number of people with Ménière’s disease is difficult to measure accurately because no official reporting system exists. The National Institutes of Health estimates that about 615,000 people in the U.S. have Ménière’s disease and that 45,500 new cases re-diagnosed each year.