Pivotal study in TBI

There are no specific pharmaceutical therapies available for TBI. Since 2001, ICON staff have participated in managing multinational TBI trials with several drugs including endopeptidase inhibitor and endothelin converting enzyme inhibitors, involving more than 1,000 TBI patients.

Most recently, ICON has participated in clinical trials evaluating the administration of a nitric oxide synthase inhibitor for its potential to improve clinical outcomes after TBI, while minimising any potential risks. One such study ICON was tasked with managing is the multi-center phase III trial in Europe, which aims to determine whether the administration of the drug compared to a placebo improves neurological outcomes in patients with moderate or severe TBI¹.

The trial will recruit a total of 220 patients in 31 centres in France, the UK, Spain, Austria and Germany between 18 and 60 years of age. Trial patients receive a 48 hour intravenous infusion of either Ronopterin or a placebo starting at the earliest six hours and at the latest 18 hours after injury. Patients will also receive a catheter placement for monitoring and managing increased intracranial pressure. The primary outcome will be the extended Glasgow Outcome Score at six months. Additionally, effects on mortality, intracranial pressure and cerebral perfusion pressure will be evaluated.

References:

¹ Efficacy of VAS203 (Ronopterin) in Patients With Moderate and Severe Traumatic Brain Injury (NOSTRA-III) https://clinicaltrials.gov/ct2/show/NCT02794168