Safety and Pharmacokinetics of Riluzole in Patients With Traumatic Acute Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 8
- 主要终点
- American Spinal Injury Association Impairment Scale
研究概览
简要总结
The purpose of the study is to find out if the use of the drug Riluzole is both safe and improves outcome in patients with acute traumatic spinal cord injury (SCI).
详细描述
The primary aim of the study is to develop acute care safety and pharmacokinetic profiles of riluzole in patients who have sustained a acute traumatic spinal cord injury. Secondary objectives are to conduct exploratory analyses of functional outcomes for purposes of planning a subsequent Phase II randomized study of the efficiency of Riluzole for the treatment of acute traumatic spinal cord injury.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age equal to or greater than 18 years and less than or equal to 70 years;
- •Willing to give written informed consent to participate in the study. The informed consent may require legally authorized representative to sign if arm/hand function is compromised.
- •No other life-threatening injury
- •Spinal cord injury at the neurologic level from C4 to T12
- •ASIA Impairment Scale level A, B or C
- •No cognitive impairment which would preclude an informed consent (including moderate or severe traumatic brain injury)
- •Less than 12 hours since injury
排除标准
- •Equal or more than 12 hours since injury
- •Hypersensitivity to riluzole or any of its components
- •Unable to receive riluzole orally or via nasogastric tube
- •History of liver or kidney disease (e.g. Hepatitis A, B or C, Cirrhosis, etc.)
- •Has a recent history of regular substance abuse (illicit drugs, alcohol)
- •Unconscious
- •Penetrating spinal cord injury
- •Pregnancy as established by urine pregnancy test
- •Breastfeeding
- •Life expectancy less than 12 months
- •Is currently involved in another therapeutic SCI research study that precludes or complicates participation in this study (e.g. study of another therapeutic drug aiming for spinal cord injury recovery, any study that substantially interferes with the follow -up schedule (f/u) schedule, or any high risk study that complicates evaluation of safety outcomes. Types of studies that would not preclude participation are e.g. behavioral adaptation studies, mental health interventions)
- •Has a mental disorder or other illness, which in the view of the site investigator, would preclude accurate evaluation (e.g. schizophrenia, severe cognitive disability, Parkinson disease)
- •Unable to commit to the follow-up schedule
- •Is a prisoner
- •Unable to converse, read or write English at the elementary school level
结局指标
主要结局
American Spinal Injury Association Impairment Scale
时间窗: Baseline, days 3 and 14, 6 weeks, 3 and 6 months and unscheduled follow-up
Neurological assessment and classification of spinal cord injury
次要结局
未报告次要终点
研究者
Robert G. Grossman, MD
Professor, Department of Neurosurgery
The Methodist Hospital Research Institute