NOSTRA III

Full title: EFFICACY OF VAS203 IN PATIENTS WITH MODERATE AND SEVERE TRAUMATIC BRAIN INJURY 

Aim: evaluate if the new drug VAS203 (produced by vasopharm GmbH, Würzburg, Germany) is effective in preventing and/or reducing the swelling of brain in patients, who have suffered from an acute moderate to severe head trauma and so improve their outcome.  Also the tolerability and safety of this new treatment is being closely evaluated.

Background: Traumatic Brain Injury (TBI) is the leading cause of death and disability among young adults in developed countries. Doctors and pharmaceutical companies are investigating new types of treatment in order to improve the treatment options for this condition.  Clinical studies must be carried out in patients before new drugs can be launched on the market. VAS203 is an experimental new drug (study drug) and has not yet been approved to be sold in your country.

may cause life threatening swelling of your brain (also called “intracranial pressure”), which elevates the pressure within your skull. This increased pressure could damage your brain.

The study drug VAS203 is believed to prevent the excessive production of a substance produced naturally in your body which when produced excessively after head injury- plays a key role in brain swelling and increased pressure within the skull.

The study drug VAS203 is being developed to treat life-threatening increased intracranial pressure which may develop following head injury.

The new drug has been tested for safety and tolerance in 33 healthy volunteers and in 32 patients suffering from accident induced head injury in three clinical studies completed in Europe.

This clinical study is being carried out in order to evaluate if the new drug VAS203 (produced by vasopharm GmbH, Würzburg, Germany) is effective in preventing and/or reducing the swelling of brain in patients, who have suffered from an acute moderate to severe head trauma and so improve their outcome.  Also the tolerability and safety of this new treatment is being closely evaluated.

The study drug will be administered in addition to the standard treatment.

Whereas the period of drug treatment will be only 48 hours the initial study procedures to assess the effect of the treatment will occur during the first 14 days and each patient will be seen 3 and 6 months after their injury.

This study is carried out in accordance with current UK legislation and internationally recognised principles.