Division of Neurosurgery, University of the Philippines-Philippine General Hospital, Manila , Philippines.
Section of Neurosurgery, Department of Surgery, Northern Mindanao Medical Center, Cagayan de Oro City , Misamis Oriental , Philippines.
Neurosurgery. 2023 Oct 1;93(4):939-951. doi: 10.1227/neu.0000000000002512. Epub 2023 May 2.
Traumatic brain injury (TBI) remains a leading cause of death and disability, affecting approximately 69 million individuals each year worldwide. A significant portion of TBI research has focused on treatments for neuroprotection and/or neurorecovery, with most failing to transition to successful clinical applications despite promising animal/in vitro study results. MLC901 (NeuroAiD II), with origins from a traditional Chinese medicine, has been shown to exhibit both neuroprotective and neuroregenerative properties in in vitro and animal studies for stroke and TBI. Clinical trials have demonstrated its safety with significant improvements in some functional outcome and cognitive domain measures. The objective of this study is to determine the efficacy and safety of MLC901 (NeuroAiD II) vs placebo in adult patients with moderate TBI.
This is a multicenter randomized double-blind placebo-controlled trial that aims to enroll 120 adult patients with moderate TBI receiving standard of care in 2 arms: MLC901 vs placebo for a treatment period of 6 months with a further follow-up of 3 months. The total duration of the study is 9 months. The primary end point is Glasgow Outcome Scale Extended (GOS-E) at 6 months. Other assessments include mortality at 6 months, GOS-E, Glasgow Coma Scale, Montreal Cognitive Assessment Filipino Version, Frontal Assessment Battery Conflicting Instructions and Go-No-Go, Rivermead Post-Concussion Symptom Questionnaire, Barthel Index, Hospital Anxiety and Depression Scale, and Health related Quality of life (EQ-5D) at 1, 3, 6, and 9 months. Cerebral swelling at baseline and at 1 and 2 weeks will also be documented. Adverse events and drug compliance will also be monitored.
We expect to find a significant improvement in functional and cognitive outcomes in patients who were given MLC901.
Previous studies on the effect of MLC901 in adult patients with moderate TBI showed positive results; However, these studies are limited by the small number of patients. This study will establish a more definitive role of MLC901 in improving functional and cognitive outcomes in patients with moderate TBI.
创伤性脑损伤（TBI）仍然是全球范围内导致死亡和残疾的主要原因，每年影响约 6900 万人。TBI 研究的很大一部分集中在神经保护和/或神经恢复的治疗上，尽管动物/体外研究结果有希望，但大多数治疗方法都未能成功转化为临床应用。MLC901（NeuroAiD II）源自一种中药，已在体外和动物研究中显示出对中风和 TBI 的神经保护和神经再生作用。临床试验表明，它在一些功能结局和认知领域测量方面具有安全性和显著改善。本研究的目的是确定 MLC901（NeuroAiD II）与安慰剂在成人中度 TBI 患者中的疗效和安全性。
这是一项多中心随机双盲安慰剂对照试验，旨在招募 120 名接受标准护理的成人中度 TBI 患者，分为 2 组：MLC901 与安慰剂治疗 6 个月，进一步随访 3 个月。研究总时长为 9 个月。主要终点是 6 个月时的格拉斯哥结局量表扩展版（GOS-E）。其他评估包括 6 个月时的死亡率、GOS-E、格拉斯哥昏迷量表、菲律宾版蒙特利尔认知评估、额叶评估电池冲突指令和 Go-No-Go、Rivermead 脑震荡后症状问卷、巴氏指数、医院焦虑抑郁量表和健康相关生活质量（EQ-5D）在 1、3、6 和 9 个月时。还将记录基线和 1 周和 2 周时的脑肿胀情况。还将监测不良事件和药物依从性。
我们预计给予 MLC901 的患者在功能和认知结果方面会有显著改善。
先前关于 MLC901 对成人中度 TBI 患者影响的研究显示出积极的结果；然而，这些研究受到患者数量较少的限制。本研究将确定 MLC901 在改善中度 TBI 患者功能和认知结局方面的更明确作用。
