MLC901 may be effective in treatment of post-concussion symptoms in phase III study

1. MLC901 significantly improved post-concussion symptoms, quality of life, and mood at 6 and 9 months.

2. MLC901 was safe and well tolerated with high adherence and no serious adverse events.

3. MLC901 did not significantly improve complex attention compared to placebo at 6 months.

Evidence Rating Level: 1 (Excellent)

This double-blind, placebo-controlled, multicenter phase III trial evaluated the efficacy and safety of MLC901 (NeuroAiD™II), a botanical supplement derived from traditional Chinese medicine, for treating cognitive impairment following mild traumatic brain injury (TBI). Given the absence of effective pharmacological treatments for cognitive sequelae of mild TBI—affecting up to 40% of patients—this study aimed to assess MLC901’s effect on complex attention, using the CNS Vital Signs (CNS-VS) test as the primary outcome at 6 months. A total of 182 adults aged 18–65 years, 1–12 months post-mild TBI and with cognitive complaints, were randomized to receive MLC901 or placebo for 6 months. While the primary outcome (complex attention) showed no significant difference between groups at 6 months (LSMD = −1.18; p = 0.58), secondary outcomes demonstrated statistically and clinically significant improvements in post-concussion symptoms (Rivermead Post-Concussion Symptoms Questionnaire), quality of life (QOLIBRI), and mood (Hospital Anxiety and Depression Scale) at both 6 and 9 months in the MLC901 group. Importantly, benefits persisted after treatment cessation. MLC901 was well tolerated with no serious adverse events. Although cognitive improvements as measured by CNS-VS were not observed—possibly due to cultural and linguistic limitations of the tool—the consistent improvements in clinical outcomes support MLC901’s potential utility in managing post-concussion symptoms.

Click to read the study in PLOSONE

Image: PD

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