Efficacy Study of NH001 in Vegetative State & Minimally Conscious State Following a Traumatic Brain Injury

Exclusion Criteria

• •1. Patients who are not clinically stable at the time of entry into the study (infections, cardiovascular decompensation, etc.)
• •2. Patients who require mechanical respiratory assistance.
• •3. Patients who show signs of progressive neurological deterioration post-TBI.
• •4. Patients with a known history of medically relevant substance abuse.
• •5. Patients with history of cardiac disease.
• •6. Patients who suffered an anoxic event.
• •7. Patients who have received an investigational drug within 30 days of the study.
• •8. Patients who have previously used NH001, other dopaminergic agent (e.g. levodopa, amantadine, domperidone) or any known neuro-stimulant (e.g. methylphenidate, amphetamines, atomoxetine, modafinil) within the last 7 days days.
• •9. Patients who are receiving dopamine blockers (e.g. risperidone, haloperidol, chlorpromazine, flupenthixol, clozapine, olanzapine, quetiapine)
• •10. Patients who are receiving drugs of the 5HT3 antagonist class, including, for example, ondansetron, granisetron, dolasetron, palonosetron and alosetron.
• •11. Patients who are receiving tricyclic antidepressants drugs
• •12. Patients who are receiving type I antiarrhythmics (i.e. quinidine).
• •13. Patients who have a known history of cardiac arrhythmias or congenital QTc prolongation.
• •14. Patients who have a known history of previous neurological functional impairment (e.g. stroke, spinal cord injury, dementia, epilepsy, psychiatric diseases).
• •15. Patients who experienced seizures within the first week post injury or have ongoing seizures.
• •16. Patients receiving prophylactic anti-convulsive medications.
• •17. Patients with known allergies to apomorphine, morphine, sulfites or trimethobenzamide.
• •18. Patients who are receiving nitrates or other vasodilators.
• •19. Patients receiving CNS acting agents such as barbiturates, morphine, belladonna, opiates.
• •20. For male patients, patients who are receiving trazodone or any other drug that is known to produce priapism.
• •21. Patients without a relative or legal guardian to consent to the study.
• •22. Patients who, according to the investigator's opinion, are unlikely to be available for the required 180-day follow up evaluation.