About 24 centres in 6 countries including France, Hungary, Romania, Lithuania, Latvia and Russia are planned to be involved in the current study to enroll 142 patients. However, the study design implicates that an interim analysis will be performed on the first 71 patients having completed the study in order to evaluate the criteria to stop for futility and decide on the continuation of the trial. The results of this interim analysis will be kept blinded from the Sponsor and the investigators and reviewed by an Independent Data Monitoring Committee (IDMC).
The initiation of the medical sites is planned for late April 2014, and the first patient to be enrolled in May 2014. The estimated time of the Last Patient In for interim analysis is Feb 2015, following which the recruitment will be put on hold until the Interim analysis is performed and the results are derived. The trial is planned to be resumed in May 2015, enrolling the last patient in October 2015.
The Investigational product is hard capsules of 10 mg strength that will be administrated 4 capsules a day in comparison with placebo over 6 weeks in patients with acute exacerbation of schizophrenia.
The current study is a proof of concept one, and the primary objective of the trial is to assess the efficacy of the proposed design, dose and administration scheme.
The secondary objective is to assess safety of the tested product and to describe the pharmacokinetics of the investigational drug in the current patient population, as well as to assess the genotype-efficacy relationship.
Proof-of-concept (POC) clinical trials are carefully designed to give preliminary evidence of efficacy and safety of the investigational drug in the target population, aiming to support a decision about proceeding into full development of the drug or stopping for the reason of futility. It also helps to explore the relationship between the dose and desired activity.
The decision made as a result of a POC is usually based on whether a required effect is achieved in comparison to placebo or a comparator treatment, and whether the trial is able to answer the addressed question within a reasonable time frame and budget. Such a study should be as small as possible; however, large enough to be able to detect the defined drug effect at the same time exposing a minimum number of subjects to an experimental drug.
OCT has a serious experience in neurology and CNS – 10 studies have been conducted since 2010, and now our proven track record has widened with a schizophrenia indication. Close relations with principal investigators and key opinion leaders in a great number of therapeutic areas make us feel confident in the speedy enrollment and quality of data derived from the clinical trials we conduct all over Russia, CIS countries, Baltic States and other regions of our operation.