Brain InjuryPhase 2NH001-2NCT00761228
Efficacy Study of NH001 in Vegetative State & Minimally Conscious State Following a Traumatic Brain Injury
A Phase 2 study testing Apomorphine in people with Brain Injury, run by NeuroHealing Pharmaceuticals Inc. at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Brain Injury
- What is being tested?
- Apomorphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Dec 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Spaulding Rehabilitation Hospital
Boston, Massachusetts, 02114
About this study
Official title: A Double-blind, Placebo-controlled, Randomized Study of the Safety and Efficacy of NH001 in Improving the Functional Outcome of Patients in a Vegetative State or Minimally Conscious State Following a Severe Traumatic Brain Injury
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
- Brain Injury
- Being tested
- Apomorphine, Placebo
- Keywords
- Vegetative State, Minimally Conscious State, Coma, Traumatic Brain Injury
- Medical subject headings
- Brain Injuries, Persistent Vegetative State, Coma, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApomorphineDrug
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.
PlaceboDrug
Patients will receive a continues subcutaneous infusion of saline solution.
| Study group | Role | What they receive |
|---|---|---|
| Apomorphine | Active comparator | Patients will receive an ascending dosing schedule to reach a maximum infusion rate of up to 6 mg/hour for 12 hours a day. Receives: Drug: Apomorphine |
| Placebo | Placebo comparator | Patients will receive a continues subcutaneous infusion of saline solution. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence or absence of meaningful responses to external commands based on Coma Recovery Scale-Revised
Measured: Day 42 or the day that the drug treatment is discontinued, whichever happens earlier.
Secondary outcomes (1)
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.
Measured: Baseline, weekly during drug treatment and at follow up visits of days 90,180 and 360.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2008 (estimated)
- Study startJul 2010
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NeuroHealing Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- FDA Office of Orphan Products Development
- Responsible party
- Sponsor
- Investigators
- Elkan R Gamzu, PhD, Principal investigator, NeuroHealing Pharmaceuticals Inc.Ross D Zafonte, DO, Principal investigator, Spaulding Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00761228
- Sponsor's protocol ID
- 3337
- Acronym
- NH001-2
- Status last verified
- Mar 2017
- First submitted
- 26 Sep 2008
- Last updated
- 31 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled, Randomized Study of the Safety and Efficacy of NH001 in Improving the Functional Outcome of Patients in a Vegetative State or Minimally Conscious State Following a Severe Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT00761228
- Acronym / sponsor ID
- NH001-2 / 3337
- Conditions
- Brain Injury
- Keywords
- Vegetative State, Minimally Conscious State, Coma, Traumatic Brain Injury
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Suspended
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- NeuroHealing Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Collaborators
- FDA Office of Orphan Products Development
- Study start
- Jul 2010
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 29 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 minimally conscious state following a severe traumatic brain injury (TBI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apomorphine | Active comparator | Drug: ApomorphinePatients will receive an ascending dosing schedule to reach a maximum infusion rate of up to 6 mg/hour for 12 hours a day. |
| Placebo | Placebo comparator | Drug: PlaceboPatients will receive a continues subcutaneous infusion of saline solution. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ApomorphinePatients 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. | Drug | Apomorphine |
| PlaceboPatients will receive a continues subcutaneous infusion of saline solution. | Drug | Placebo |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elkan R Gamzu, PhD principal investigator
NeuroHealing Pharmaceuticals Inc.
Ross D Zafonte, DO principal investigator
Spaulding Rehabilitation Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Apomorphine in people with Brain Injury, run by NeuroHealing Pharmaceuticals Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 31 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2017.