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

Paused · Phase 2 · Has a placebo group

Conditions studied: Brain Injury

In brief

The purpose of this study is to test the drug apomorphine in subjects who are in a Vegetative State or a Minimally Conscious State.

Key facts

Study ID

NCT00761228

Run by

NeuroHealing Pharmaceuticals Inc.

People needed

76

Starts

2010-07-01

Expected to finish

2018-12-01

Last updated by the study team

2017-03-31

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Spaulding Rehabilitation Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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