SuspendedNCT00761228NH001-2Updated Mar 31, 2017

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

A Phase 2 interventional study of Apomorphine and Placebo in Brain Injury, sponsored by NeuroHealing Pharmaceuticals Inc.. Suspended at 1 site in United States. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2017-03-31.

Primary conditionBrain Injuries, TraumaticRegistry: Brain InjuriesReclassifiedWhy we changed it

Registry

Brain Injuries — the first condition term the registry derived for this study.

ClinicalTrials.gg

Brain Injuries, Traumatic

Why

The study's title name Brain Injuries, Traumatic, a narrower term within Brain Injuries.

Confidence

High: the new condition is named in the study's own title. Of 46 hand-checked studies reclassified this way, 72% were exactly right and 89% in the right disease family; the registry's first term was right for 4% (measured 2026-10-21). How we classify →

Wrong?

Tell us the study's main condition →

Sponsored by NeuroHealing Pharmaceuticals Inc. · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 76
Allocation: Randomized
Ages: 18 Years to 50 Years
Sex: All

Study 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.

Read the 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 minimally conscious state following a severe traumatic brain injury (TBI).

Conditions studied

Brain Injury

Browse trials for

Brain Injuries 946Registry's first term
Persistent Vegetative State 88
Coma 138
Brain Injuries, Traumatic 1,721Primary · reclassified

Keywords

Vegetative State
Minimally Conscious State
Coma
Traumatic Brain Injury

In context

Brain Injuries, Traumatic Reclassified

1,721 studies on the registry are indexed under Brain Injuries, Traumatic; 447 are open to participants now.

This study's planned enrollment of 76 is above the median of 52 across 1,088 interventional studies indexed under Brain Injuries, Traumatic.

Browse Brain Injuries, Traumatic studies →

Lead sponsor

NeuroHealing Pharmaceuticals Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.

Compared within Brain Injuries, Traumatic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Brain Injuries. The counts are of registry records indexed under each term, refreshed daily. How we classify →

Who can participate

Ages eligible: 18 Years to 50 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Patient is between 18 and 50 years of age, inclusive.
Male or non-pregnant female (females of 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.
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 criteria

Exclusion Criteria:

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 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 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.

Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 76 participants (estimated)

Study arms

Active comparator
Apomorphine
Patients will receive an ascending dosing schedule to reach a maximum infusion rate of up to 6 mg/hour for 12 hours a day.
Drug: Apomorphine
Placebo comparator
Placebo
Patients will receive a continues subcutaneous infusion of saline solution.
Drug: Placebo

Interventions

DrugApomorphine
Patients will receive an ascending dosing schedule of continuous subcutaneous apomorphine to reach a maximum infusion rate of up to 6 mg/hour for 12 hours a day.
DrugPlacebo
Patients will receive a continues subcutaneous infusion of saline solution.

What researchers measure

Primary outcomes

Presence or absence of meaningful responses to external commands based on Coma Recovery Scale-Revised
Time frame: Day 42 or the day that the drug treatment is discontinued, whichever happens earlier.

Secondary outcomes

Coma/Near Coma Scale (CNC) Disability Rating Scale (DRS), Glasgow Outcome Scale Extended (GOS-E), ability to participate in 3 hours a day of active rehabilitation, and a clinical impression of change.
Time frame: Baseline, weekly during drug treatment and at follow up visits of days 90,180 and 360.

Study locations

1 site

Spaulding Rehabilitation Hospital
Boston, Massachusetts 02114, United States

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2010, a primary completion of Dec 2018 and a completion of Dec 2018. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered: Sep 26, 2008
First posted: Sep 29, 2008
Start: Jul 2010
Primary completionEst.: Dec 2018
CompletionEst.: Dec 2018
Last update: Mar 31, 2017

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Mar 31, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00761228
Lead sponsor: NeuroHealing Pharmaceuticals Inc.
Collaborators: FDA Office of Orphan Products Development
Responsible party: Sponsor
First posted: Sep 29, 2008
Start date: Jul 2010
Primary completion: Dec 2018 (estimated)
Completion: Dec 2018 (estimated)
Last update: Mar 31, 2017

Study contacts

Elkan R Gamzu, PhD

principal investigator · NeuroHealing Pharmaceuticals Inc.

Ross D Zafonte, DO

principal investigator · Spaulding Rehabilitation Hospital

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is suspended, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Studies of the drug tested here: Apomorphine

Other studies in this condition

Brain Injuries, Traumatic →

Other studies from this sponsor

NeuroHealing Pharmaceuticals Inc.

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