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. After the approval for the trial conduct are received from the Ministries of Healthcare of the Russian Federation and Ukraine, the required LEC approvals are received and the investigational product is shipped to the investigational sites, OCT will start sites initiation in Russian and Ukrainian medical centers. As for Russia, 12 sites are planned to be involved in the study; as for Ukraine, the number of sites to be initiated is 8. Thus, 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 (according to the
OCT has serious experience in conducting phase III studies in Russia, Ukraine and other countries of our operations. For this project, we are providing full-service support and will do our best to do it on the highest level.