The decision to file the protocol was made after the FDA accepted without comment the report on the results of the traumatic brain injury (TBI) Phase II-a safety study.
The company’s planned multi-center, double-bind, placebo-controlled study would enroll up to 300 patients. Approximately 200 patients will be allowed for enrollment through a recently approved $1.9 million grant from the US Department of Defense to Ross Bullock, of the University of Miami Miller School of Medicine, department of Neurosurgery. Dr Bullock is the principal investigator for the planned Phase II-b clinical trial. The company plans to do an interim analysis after enrolling 100 patients and then may elect to enroll up to 300.