NCT00761228暂停2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Presence or absence of meaningful responses to external commands based on Coma Recovery Scale-Revised
研究概览
简要总结
The purpose of this study is to test the drug apomorphine in subjects who are in a Vegetative State or a Minimally Conscious State.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Apomorphine (Drug)
Placebo
Placebo Comparator
Patients will receive a continues subcutaneous infusion of saline solution.
干预措施: Placebo (Drug)
结局指标
主要结局
Presence or absence of meaningful responses to external commands based on Coma Recovery Scale-Revised
时间窗: Day 42 or the day that the drug treatment is discontinued, whichever happens earlier.
次要结局
- 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.)
研究者
研究点 (1)
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