NCT00761228SuspendedPhase 2
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
NeuroHealing Pharmaceuticals Inc.1 site in 1 country76 target enrollmentStarted: July 2010Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Suspended
- Enrollment
- 76
- Locations
- 1
- Primary Endpoint
- Presence or absence of meaningful responses to external commands based on Coma Recovery Scale-Revised
Study Overview
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 minimally conscious state following a severe traumatic brain injury (TBI).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •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.
Arms & Interventions
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.
Intervention: Apomorphine (Drug)
Placebo
Placebo Comparator
Patients will receive a continues subcutaneous infusion of saline solution.
Intervention: Placebo (Drug)
Outcomes
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.(Baseline, weekly during drug treatment and at follow up visits of days 90,180 and 360.)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Not Applicable
A randomized, double blind, placebo-controlled, phase 2a study of the efficacy, safety and pharmacokinetics of MLN3897 in patients with rheumatoid arthritis taking methotrexate.Rheumatoid arthritis (RA)NL-OMON27198Millennium Pharmaceuticals Inc.186
Active, not recruiting
Not Applicable
A randomized. double-blind, placebo-controlled, phase III trial for the efficacy of Traumeel S in the prevention and treatment of chemotherapie-induced Mucositis in Patients undergoing allogeneic stem cell transplantation - TraumeelTreatment of chemotherapie-induced oral mucositisMedDRA version: 8.1Level: LLTClassification code 10028130Term: Mucositis oralEUCTR2006-000821-74-DEniversity Hospital of Muenster
Active, not recruiting
Not Applicable
A double-blind, randomised, placebo controlled, phase I/IIa dose escalation study to investigate the safety and the effect of different doses of Oralgen House Dust Mite in patients with house dust mite induced allergic rhinoconjunctivitisEUCTR2008-003879-49-GBArtu Biologicals Europe B.V.
Active, not recruiting
Not Applicable
A double-blind, randomised, placebo controlled, phase I/IIa dose escalation study to investigate the safety and tolerability of Oralgen Birch Pollen immunotherapy in patients with allergic rhinoconjunctivitisAllergic rhinoconjunctivitisMedDRA version: 9.1Level: LLTClassification code 10001728Term: Allergic rhinoconjunctivitisEUCTR2008-003861-17-SEArtu Biologicals Europe B.V.
Active, not recruiting
Not Applicable
Fulvestrant +/- vandetanib in advanced aromatase inhibitor resistant breast cancer.Metastatic breast cancer that has become resistant to aromatase inhibitor therapyEUCTR2014-001208-23-GBVelindre NHS Trust