Safety and Use of MLC601/MLC901 (NeuroAiDTM) in Primary Intracerebral Hemorrhage: A Cohort Study from the NeuroAiD Safe Treatment Registry

Brain Sci. 2020 Jul 30;10(8):499. doi: 10.3390/brainsci10080499.


Background: MLC601/MLC901 (NeuroAiD™) is a combination of natural products shown to be safe and to aid neurological recovery after brain injuries, especially ischemic stroke. Few studies have investigated NeuroAiD in primary intracerebral hemorrhage (ICH). The NeuroAiD Safe Treatment (NeST) Registry explores NeuroAiD use in the real-world setting. This cohort study aimed to assess its use and safety in ICH.

Methods: The online NeST Registry of subjects with ICH given NeuroAiD prospectively collected clinical data at baseline and monthly visits (V) 1 to 3. Outcome measures included compliance, side effects, Glasgow Coma Scale (GCS), National Institutes of Health Stroke Scale (NIHSS), modified Rankin Scale (mRS), and Short Orientation-Memory-Concentration Test (SOMCT).

Results: Sixty-six subjects were included. NeuroAiD was well-tolerated with fair compliance over three months. Two non-serious side effects were reported. Mean scores significantly improved on all outcome scales. The proportion of subjects with favorable outcomes significantly improved from baseline to V3: NIHSS 0-4, from 12% to 59% (p < 0.0001); GCS 13-15, from 64% to 88% (p = 0.007); mRS 0-1, from 9% to 37% (p = 0.004); and SOMCT score 0-8, from 44% to 68% (p = 0.029).

Conclusions: NeuroAiD in the real-world setting was safe and showed potential for a sustained positive effect on neurological recovery after ICH.

Keywords: MLC601; MLC901; clinical outcomes; hemorrhagic stroke; intracerebral hemorrhage; registry.