MLC901 for Moderate to Severe Traumatic Brain Injury: Pilot, Randomized, Double-Masked, Placebo-controlled Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- functional outcome 5
研究概览
简要总结
Patients with a diagnosis of moderate to severe traumatic brain injury (TBI) will be enrolled. Subjects will be randomly assigned to receive either MLC901 (Specified Drug Code) or placebo capsules three times per day over 6 months. Evaluation of patients will be carried out at baseline as well as at 3-month and 6-month follow-up visits. Modified Rankin Scale (mRS) and Glasgow outcome scale (GOS) will be used to examine patients. Efficacy will be evaluated by comparing these two scores between the 2 groups at follow-up visits.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 15 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 15 and 65
- •non-penetrating moderate (Glasgow Coma Scale score [GCS] 9-12) or severe (GCS 3-8) traumatic brain
- •injury less than 24 hrs from traumatic injury
- •anticipated intensive care unit length of stay at least 48 hrs
排除标准
- •GCS = 3 and fixed dilated pupils or penetrating injury
- •coexisting injury or medical conditions which could adversely affect our study outcome measures
- •dependence for everyday activities before the injury
- •pregnancy or breastfeeding
- •known allergy to any of MLC901 components
研究组 & 干预措施
Drug
MLC901 capsules three times per day over 6 months
干预措施: MLC901 or Placebo (Drug)
Placebo
Placebo capsules three times per day over 6 months
干预措施: MLC901 or Placebo (Drug)
结局指标
主要结局
functional outcome 5
时间窗: at 3rd month post-injury
functional outcome scales of MRS
functional outcome 1
时间窗: at baseline
functional outcome scales of GOS
functional outcome 2
时间窗: at 3rd month post-injury
functional outcome scales of GOS
functional outcome 3
时间窗: at 6th month post-injury
functional outcome scales of GOS
functional outcome 6
时间窗: at 6th month post-injury
functional outcome scales of MRS
functional outcome 4
时间窗: at baseline
functional outcome scales of MRS
次要结局
未报告次要终点
研究者
Ali Amini Harandi
Prof
Shahid Beheshti University