Date: 2011-03-03
Type of information: Clinical research agreement
Compound: NeuroSTAT®
Company: NeuroVive Pharmaceutical (Sweden) European Brain Injury Consortium (EBIC - network of European neurological research and medical units highly experienced in the care of patients with brain injuries)
Therapeutic area: CNS diseases - Traumatology
Type agreement: clinical collaboration
Action mechanism:
Disease: neuroprotection in patients with traumatic brain injury
Details: NeuroVive has signed an agreement with the European Brain Injury Consortium (EBIC) to conduct a European multi-center Phase II/III clinical trial of NeuroSTAT® for neuroprotection in patients with traumatic brain injury (TBI). The goal of the collaboration is to secure the highest possible study quality and compliance with clinical standards to support NeuroSTAT®\'s rapid progress toward commercialization. To this end, NeuroVive will work closely with EBIC\'s key European experts in the field of neurotrauma and acute brain injuries. NeuroVive will manage the study in close collaboration with the EBIC group and a clinical research organization (CRO) to be selected. The collaboration with EBIC includes development of the study protocol, site selection, patient recruitment, and statistical support. This adaptive design Phase II/III study will determine the safety and efficacy of NeuroSTAT® in moderate to severe TBI.
Financial terms:
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