? Each year 1.4 million Americans sustain a TBI. Of these patients, 50,000 people die and 235,000 people are hospitalized and survive. The survivors often remain in a state of altered consciousness (coma, VS or MCS) for an extended period of time. These states of altered consciousness are characterized by the lack of awareness and lack of interaction with the environment. Patients that remain in a VS or a MCS for one month after a TBI, have a poor prognosis. Thirty-three percent die, 43% remain in a vegetative state or are severely disabled and only 24% make a moderate or good recovery. ? ? Dopamine agonists have been shown to help in regaining consciousness and facilitating rehabilitation. They induce awareness, accelerate the recovery and improve the functional outcome of post-TBl coma VS and MCS patients. ? ? In 2006, NeuroHealing Pharmaceuticals received an orphan drug designation for NH001 for the treatment of patients in a VS or MCS. Apomorphine is a FDA approved drug for the treatment of Parkinson's disease. It is a more powerful dopamine agonist than any of the dopamine agents previously tried in post-TBI unconscious patients. It is administered subcutaneously using a portable infusion pump for 12 hours per day. A steady high level of dopamine stimulation is achieved during the diurnal hours and the patient is allowed to rest during the night. ? ? NeuroHealing is currently conducting a 10-patient open-label clinical study of NH001 to test this hypothesis. Six patients have been treated thus far. All have regained consciousness, recovered their ability to follow commands, and their capacity to participate in active physical and cognitive rehabilitation. Three patients have been followed for over one year with no lapses back into unconsciousness. ? ? The investigators propose to conduct a clinical study to evaluate the hypothesis that patients treated with NH001 will experience a more rapid return to consciousness with better functional outcomes than patients receiving placebo. ? ? ?
