- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00761228
Efficacy Study of NH001 in Vegetative State & Minimally Conscious State Following a Traumatic Brain Injury (NH001-2)
March 29, 2017 updated by: NeuroHealing Pharmaceuticals Inc.
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.
Study Overview
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 Type
Interventional
Enrollment (Anticipated)
76
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Spaulding Rehabilitation Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 48 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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 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 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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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.
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Placebo Comparator: Placebo
Patients will receive a continues subcutaneous infusion of saline solution.
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Patients will receive a continues subcutaneous infusion of saline solution.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
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Day 42 or the day that the drug treatment is discontinued, whichever happens earlier.
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
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Baseline, weekly during drug treatment and at follow up visits of days 90,180 and 360.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Elkan R Gamzu, PhD, NeuroHealing Pharmaceuticals Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2010
Primary Completion (Anticipated)
December 1, 2018
Study Completion (Anticipated)
December 1, 2018
Study Registration Dates
First Submitted
September 26, 2008
First Submitted That Met QC Criteria
September 26, 2008
First Posted (Estimate)
September 29, 2008
Study Record Updates
Last Update Posted (Actual)
March 31, 2017
Last Update Submitted That Met QC Criteria
March 29, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Brain Damage, Chronic
- Craniocerebral Trauma
- Trauma, Nervous System
- Unconsciousness
- Consciousness Disorders
- Brain Injuries
- Wounds and Injuries
- Brain Injuries, Traumatic
- Persistent Vegetative State
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Gastrointestinal Agents
- Dopamine Agonists
- Dopamine Agents
- Emetics
- Apomorphine
Other Study ID Numbers
- 3337
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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