Loberamisal Improves Functional Recovery After Acute Ischemic Stroke: JAMA
China: A new study published in JAMA has revealed that intravenous loberamisal, compared with placebo, increased the likelihood of achieving a full functional outcome at 90 days among patients with acute ischemic stroke treated within 48 hours of symptom onset. However, further studies are needed to confirm these findings and determine whether the benefits extend to a broader patient population.
The Loberamisal for Acute Ischemic Stroke (LAIS) randomized clinical trial was conducted by Shuya Li, Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China, and colleagues. The multicenter, double-blind, placebo-controlled phase 3 trial examined whether loberamisal could improve recovery following acute ischemic stroke.
Despite advances in reperfusion treatment, effective therapies aimed at protecting brain tissue and supporting neurological recovery after ischemic stroke remain limited. Loberamisal is a small-molecule agent designed to act on two pathways involved in neuronal injury and recovery: the postsynaptic density 95 (PSD-95) pathway and the α2 GABA-A receptor.
The trial enrolled 998 adults aged 18 to 80 years with acute ischemic stroke at 32 hospitals across China. Participants had a baseline National Institutes of Health Stroke Scale (NIHSS) score between 7 and 20, no significant prestroke disability, and presented within 48 hours of symptom onset. Recruitment occurred from July 2024 through December 2024, with final follow-up completed in April 2025.
Participants were randomly assigned to receive either 40 mg of intravenous loberamisal or matching placebo once daily for 10 consecutive days, alongside standard stroke treatment. The primary endpoint was a modified Rankin Scale (mRS) score of 0 to 1 at 90 days, indicating no symptoms or minimal disability in daily activities.
Of the randomized participants, 997 received at least one dose and were included in the primary analysis. The median age was 64 years, 33.7% were women, and the median baseline NIHSS score was 8.
The researchers reported:
- 69.7% of patients receiving loberamisal achieved an mRS score of 0 to 1 at 90 days, compared with 56.3% receiving placebo.
- Loberamisal was associated with a 24% higher relative likelihood of achieving a full functional outcome (RR, 1.24).
- The absolute difference between groups was 13.28 percentage points.
- Adverse events occurred in 87.8% of the loberamisal group and 88.7% of the placebo group.
- Serious adverse events were reported in 8.6% versus 10.7%, respectively.
- All-cause mortality occurred in 1.2% of loberamisal-treated patients versus 2.0% with placebo.
The study had several limitations, including no significant differences in some secondary outcomes, such as early NIHSS improvement and achieving a Barthel Index score ≥95 at 90 days. Its generalizability was also limited by enrollment at Chinese centers, underrepresentation of very mild and severe strokes, exclusion of patients undergoing endovascular thrombectomy, and the absence of biomarker or imaging analyses.
Overall, loberamisal improved functional recovery without an apparent increase in adverse events. Further studies in broader and more diverse stroke populations are needed to confirm these findings and establish its neuroprotective and neuroreparative potential.
Reference:
Li S, Feng B, He D, et al. Loberamisal for Acute Ischemic Stroke: The LAIS Randomized Clinical Trial. JAMA. Published online September 10, 2026. doi:10.1001/jama.2026.16557
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