This is a double-blind placebo-controlled randomized multi-center phase II clinical trial to estimate the efficiency and safety of the investigational drug in patients with alcohol abuse. The study will be held in adaptive design in two periods.
The adaptive design presumes that in the first period of the study 72 patients with alcohol addiction that have undergone detoxification procedures within 5-10 days prior to start of treatment will be randomized into 4 groups. Those patients will be treated with one of the two doses of either the investigational drug or placebo. Upon completion of their treatment, interim data analysis will be conducted and one of those two doses will be chosen for the second period of the investigation, when approximately 48 more patients will be randomized into two equal groups. During the second study period, efficiency and safety of the investigational drug will be confirmed.
Thus, the total number of 142 patients are planned to be recruited for the current study so as to randomize 120 of them during the two study periods. For this aim, OCT have involved 6 investigational sites in Russia which are planning to enroll 72 patients for the first period within 4 months and the rest number of the patients for the second period within 3 months. The estimated mean enrollment rate per 1 medical center will thus be about 6 patients per site per month.
Project team expects that patients enrollment will be completed within the necessary timelines for the both study periods since OCT has strong relations with the principal investigators and the selected medical sites. Moreover, incidence rates of alcoholism in Russia can confirm the expected enrollment rates: according to the World Health Organization reports of the last several years, alcohol consumption in Russia is among the highest in the world. Annual per capita consumption of alcohol among Russians stays about 16 litres which is fourth highest volume in Europe.
OCT is providing full support to the Sponsor within the current project. OCT activities have started at the stage of medical writing and preparation of the package of documents for the regulatory submission. After the approval for this clinical trial conduct was released by the Ministry of Healthcare of the Russian Federation, OCT has started sites initiation. Now that the project has moved to the stage of patients enrollment, OCT Project team is managing the study process, providing timely monitoring visits and controlling enrollment process. OCT team is planned to be involved in the current project for about 24 months until the final study report is prepared and sent to the Sponsor.