NOSTRA III

Testing theefficacy of VAS203 in patients with moderate and severe Traumatic brain injury (TBI).

Aim

Vasopharm, a pharmaceutical company, have developed VAS203; a compound that rapidly lowers excessive nitric oxide production. Thus far the application of VAS203 has positively affected neurological outcomes. The primary objective of this trial is to investigate the safety and tolerability as well as effects of this drug in patients with TBI, in comparison to placebo.

Background/method

This study will evaluate the efficacy of the study drug: VAS203, on clinical outcomes at 6 months in patients suffering from moderate to severe traumatic brain injury (TBI). TBI is the leading cause of death and disability among young adults in developed countries. Neurological damage after TBI is caused not only by the impact itself, but evolves afterwards (secondary injury). Indeed, secondary injury, including raised intracranial pressure (ICP), is the major cause of death after TBI. Nitric Oxide (NO) is one of the key factors regulating the dilation of blood vessels and is involved in inflammatory processes. It has also been demonstrated to be an important component in the development of secondary brain injury. The compound, VAS203, has a similar structure to BH4; a potent inhibitor of nitric oxide synthase (NOS). Results from the Nostra phase II trial showed a beneficial effect of VAS203 on the clinical outcomes as measured by eGOS-I (extended Glasgow Outcome Scale Interview) after 6 and 12 months. Recruitment of patients is continued until up to 232 patients are randomised in a ratio of 1:1 to VAS203 and placebo respectively. The study is completed with the full analysis of 220 evaluable patients.