Abstract Background and aims Recovery after a moderately severe ischaemic stroke remains limited. MLC601 (NeuroAiD) has been investigated as a neurorestorative therapy enhancing long-term functional recovery beyond spontaneous improvement. We will present meta-analytic findings on functional outcomes with MLC601 over 24 months. Methods A meta-analysis of published clinical studies of MLC601 in stroke was conducted, comparing MLC601 with placebo in patients with moderately severe ischaemic stroke, defined by a baseline NIH Stroke Scale (NIHSS) score of 8-14. Functional recovery was defined as a modified Rankin Scale (mRS) score of 0-1 at 3, 6, 12, 18, and 24 months. Adjusted odds ratios (ORs) with 95% confidence intervals were calculated, accounting for relevant covariates. Subgroup analyses focused on patients with significant baseline motor impairment, defined as a baseline NIHSS Limb Motor Score ≥3. Results In the overall population with moderately severe stroke, MLC601 was associated with higher odds of good functional recovery, with statistically significant benefits at 6 and 12 months and a peak clinical impact during this period. In patients with baseline motor impairment, the benefit was evident as early as Month 3 and remained statistically significant through Month 24, with consistently favourable ORs (1). No attenuation or reversal of the treatment effect was observed over time. Conclusions This comprehensive meta-analysis indicates that MLC601 significantly increases the likelihood of achieving functional independence after a moderately severe ischaemic stroke, particularly in patients with early motor deficits. The early onset and long-term benefits support a neurorestorative mechanism of action addressing an important unmet need in stroke recovery. Conflict of interest Dr. N. Venketasubramanian: nothing to disclose. Pr. C. Chen: nothing to disclose
Venketasubramanian et al. (Fri,) studied this question.