Relevant information about our clinical development activities is provided below. At Desitin, we are proud of the fact that for decades we have consistently produced global innovations that have considerably improved and simplified drug treatment for doctors and patients, and have already become standard treatments. These innovations, which were and are always developed in close cooperation with leading experts and treatment centres, are the basis of our success and our reputation among health professionals, pharmacists, patients and other businesses in the pharmaceutical industry. A list of our most important innovations can be found under Innovative Technologies.
As well as recognised expertise in the area of product development, conducting clinical studies is an essential step on the path of a new product to doctor and patient. In its clinical development department, Desitin has extensive expertise in carrying out phase I, III and IV clinical studies.
In clinical development, all innovations from our product development undergo extensive clinical testing based on the latest standards. Our work focuses on epilepsy and parkinson's disease. As well as bioavailability studies and medicinal product interaction studies, we concentrate on multi-centre studies of the efficacy and tolerability of our medicinal products. In doing so, we work closely with renowned hospitals and contract research organisations.
Some of our most important projects are presented below.
Recently, two Phase I bioequivalence studies with an innovative oral dosage form of a new-generation anti-epileptic, developed by Desitin, were completed.
In cooperation with a total of eleven German hospitals specialising in parkinson's disease, an open, randomised, parallel-group, phase III study of the non-ergot dopamine agonist CLARIUM® (active substance: piribedil) has been commenced (PiViCog-PD). The aim is to compare piribedil with standard therapies for its effect on cognitive and alertness parameters in a total of 76 patients.
In addition, concomitant post-marketing non-interventional studies (NIS) of tolerability and safety are being conducted. We recently completed two NIS projects with our parkinson's disease product CLARIUM®. In June 2009 we commenced a third NIS in the field of parkinson's disease. The aim of this study is to collect long-term data on tolerability and the change in Parkinson's symptoms during treatment with CLARIUM®, paying particular attention to quality of life and treatment satisfaction.
For the indication epilepsy, a NIS with our extended-release formulation Apydan® extent (active substance: oxcarbazepine) has started at the beginning of 2010. Again, the primary aim is to generate long-term data on the safety and efficacy of the treatment after switching from other treatments or in patients being treated for the first time. By undertaking these research activities, we ensure that our products always reflect the latest scientific knowledge.
A summary of the main study parameters was published in the following study database: clinicaltrials.gov/ct2/home.