24.May.2012

Regulatory Approval of the New Study in Multiple Sclerosis Received

This early phase study was awarded to OCT-Clinical Trials in Eastern and Central Europe by one of our Russian sponsors. OCT have obtained the Russian Ministry of Health and Social Development approval of a new clinical study in Multiple Sclerosis.

This early phase study was awarded to OCT-Clinical Trials in Eastern and Central Europe by one of our Russian sponsors. OCT have obtained the Russian Ministry of Health and Social Development approval of a new clinical study in Multiple Sclerosis. The clinical trial is to be conducted at 7 investigational sites in Russia to enroll 26 patients within one month period. Thorough feasibility performed prior to the regulatory application gives us confidence in successful on-time enrollment in this study. The geography of 7 approved centers in Russia covers all the major cities in the European part of Russia.

OCT medical writers and clinical team have prepared documents required for regulatory and ethics submission for this trial. Key opinion leaders have been involved in the process of medical writing in order to guarantee successful trial application and approval. This multiple sclerosis study has been approved with no comments from MoH side within 35 working days.

Multiple Sclerosis (MS) is a chronic, immune-mediated disease of the central nervous system. It is caused by damage to the myelin, which forms the protective covering around nerve cells. When this covering is damaged, nerve impulses are slowed down or stopped. There is no one clear sign, which factors stipulate progress of MS. Globally, the median estimated incidence of MS is 2.5 per 100,000. Over 2 million people around the world have MS, including about 200.000 Russian and about 20.000 Ukrainian citizens.

OCT have conducted 3 studies in this therapeutic area since 2005. We will perform full-service clinical trial support for the sponsoring company including data management and final statistical report preparation. OCT wide network of investigative sites specialized in the neurology therapeutic area, and close relationships with these sites makes the on-time conduct of the study and adherence to the budget absolutely realistic.