Status:
SUSPENDED
Efficacy Study of NH001 in Vegetative State & Minimally Conscious State Following a Traumatic Brain Injury
Lead Sponsor:
NeuroHealing Pharmaceuticals Inc.
Collaborating Sponsors:
FDA Office of Orphan Products Development
Conditions:
Brain Injury
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to test the drug apomorphine in subjects who are in a Vegetative State or a Minimally Conscious State.
Detailed Description
This is a prospective, multi-center, randomized, double-blind, placebo-controlled study of the safety and efficacy of NH001 to improve the functional outcome of patients in a vegetative state or minim...
Eligibility Criteria
Inclusion
- Patient is between 18 and 50 years of age, inclusive.
- Male or non-pregnant female (females of child-bearing potential will be required to have undergone a pregnancy test with negative results prior to entry to the study).
- Patients will have sustained a severe closed head injury within one to four months.
- Patients will have remained in a vegetative or minimally conscious state between one and four months after injury.
- Patients will have reached a stabilized clinical state prior to admission to the study (e.g. afebrile, haemodynamic and electrolyte stability).
- Patients will have a mean DRS score between 17 and 29, when measured twice a day over two consecutive days.
- Informed consent from a legal representative will have been obtained, according to the procedures outlined in Section 8.1.2.
- Patients who, according to the investigator's opinion, are likely to be available for the required 180-day follow up evaluation.
Exclusion
- Patients who are not clinically stable at the time of entry into the study (infections, cardiovascular decompensation, etc.)
- Patients who require mechanical respiratory assistance.
- Patients who show signs of progressive neurological deterioration post-TBI.
- Patients with a known history of medically relevant substance abuse.
- Patients with history of cardiac disease.
- Patients who suffered an anoxic event.
- Patients who have received an investigational drug within 30 days of the study.
- 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.
- Patients who are receiving dopamine blockers (e.g. risperidone, haloperidol, chlorpromazine, flupenthixol, clozapine, olanzapine, quetiapine)
- Patients who are receiving drugs of the 5HT3 antagonist class, including, for example, ondansetron, granisetron, dolasetron, palonosetron and alosetron.
- Patients who are receiving tricyclic antidepressants drugs
- Patients who are receiving type I antiarrhythmics (i.e. quinidine).
- Patients who have a known history of cardiac arrhythmias or congenital QTc prolongation.
- Patients who have a known history of previous neurological functional impairment (e.g. stroke, spinal cord injury, dementia, epilepsy, psychiatric diseases).
- Patients who experienced seizures within the first week post injury or have ongoing seizures.
- Patients receiving prophylactic anti-convulsive medications.
- Patients with known allergies to apomorphine, morphine, sulfites or trimethobenzamide.
- Patients who are receiving nitrates or other vasodilators.
- Patients receiving CNS acting agents such as barbiturates, morphine, belladonna, opiates.
- For male patients, patients who are receiving trazodone or any other drug that is known to produce priapism.
- Patients without a relative or legal guardian to consent to the study.
- Patients who, according to the investigator's opinion, are unlikely to be available for the required 180-day follow up evaluation.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2018
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT00761228
Start Date
July 1 2010
End Date
December 1 2018
Last Update
March 31 2017
Active Locations (1)
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1
Spaulding Rehabilitation Hospital
Boston, Massachusetts, United States, 02114